| | Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans: Defense and Veterans Brain Injury Center Randomized Controlled Trial of Two Rehabilitation ApproachesAbstract Vanderploeg RD, Schwab K, Walker WC, Fraser JA, Sigford BJ, Date ES, Scott SG, Curtiss G, Salazar AM, Warden DL, for the Defense and Veterans Brain Injury Center Study Group. Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches. ObjectivesTo determine the relative efficacy of 2 different acute traumatic brain injury (TBI) rehabilitation approaches: cognitive didactic versus functional-experiential, and secondarily to determine relative efficacy for different patient subpopulations. DesignRandomized, controlled, intent-to-treat trial comparing 2 alternative TBI treatment approaches. SettingFour Veterans Administration acute inpatient TBI rehabilitation programs. ParticipantsAdult veterans or active duty military service members (N=360) with moderate to severe TBI. InterventionsOne and a half to 2.5 hours of protocol-specific cognitive-didactic versus functional-experiential rehabilitation therapy integrated into interdisciplinary acute Commission for Accreditation of Rehabilitation Facilities–accredited inpatient TBI rehabilitation programs with another 2 to 2.5 hours daily of occupational and physical therapy. Duration of protocol treatment varied from 20 to 60 days depending on the clinical needs and progress of each participant. Main Outcome MeasuresThe 2 primary outcome measures were functional independence in living and return to work and/or school assessed by independent evaluators at 1-year follow-up. Secondary outcome measures consisted of the FIM, Disability Rating Scale score, and items from the Present State Exam, Apathy Evaluation Scale, and Neurobehavioral Rating Scale. ResultsThe cognitive-didactic and functional-experiential treatments did not result in overall group differences in the broad 1-year primary outcomes. However, analysis of secondary outcomes found differentially better immediate posttreatment cognitive function (mean ± SD cognitive FIM) in participants randomized to cognitive-didactic treatment (27.3±6.2) than to functional treatment (25.6±6.0, t332=2.56, P=.01). Exploratory subgroup analyses found that younger participants in the cognitive arm had a higher rate of returning to work or school than younger patients in the functional arm, whereas participants older than 30 years and those with more years of education in the functional arm had higher rates of independent living status at 1 year posttreatment than similar patients in the cognitive arm. ConclusionsResults from this large multicenter randomized controlled trial comparing cognitive-didactic and functional-experiential approaches to brain injury rehabilitation indicated improved but similar long-term global functional outcome. Participants in the cognitive treatment arm achieved better short-term functional cognitive performance than patients in the functional treatment arm. The current increase in war-related brain injuries provides added urgency for rigorous study of rehabilitation treatments. (http://ClinicalTrials.gov ID# NCT00540020.) List of Abbreviations: CARF, Commission for Accreditation of Rehabilitation Facilities, DRS, Disability Rating Scale, DVBIC, Defense and Veterans Brain Injury Center, PTA, posttraumatic amnesia, RCT, randomized controlled trial, RLAS, Rancho Los Amigos Scale, TBI, traumatic brain injury, VAMC, Veterans Administration Medical Centers EACH YEAR APPROXIMATELY 1.5 million Americans sustain a TBI.1, 2 Direct medical costs and indirect costs such as lost productivity from TBI totaled an estimated $60 billion in the United States in 2000.3 Over 5 million Americans are estimated to be living with longstanding disability from TBI including cognitive, physical, psychosocial, occupational, and emotional difficulties.2, 4, 5, 6 Rehabilitation is an integral component of the medical treatment for persons with TBI. The theoretical basis for acute rehabilitation rests partly on the benefits of managing and preventing secondary complications of TBI and related trauma, and partly on direct augmentation of neurologic recovery. Experiments with brain-injured animals have repeatedly shown the efficacy of enriched environments, physical activity, and various training paradigms.7 Conventional acute medical rehabilitation in the U.S. entails 15 or more hours a week of physician-directed physical, occupational, and speech therapy, together with social services and around-the-clock rehabilitation nursing. An interdisciplinary model with cross-discipline goal-setting and frequent team communication is considered optimal and is the U.S. standard of care. Therapies commonly focus on minimizing physical (eg, range of motion of extremities, ambulation, dressing, feeding, grooming, contractures) or cognitive impairments (eg, speech, aphasic syndromes, swallowing). This expected standard of care ethically precludes efficacy studies using randomized nonrehabilitation controls. However, several quasi-experimental studies support the efficacy of specialized, acute interdisciplinary rehabilitation for patients with moderate and severe TBI.8, 9, 10, 11, 12, 13, 14 Within the framework of acute rehabilitation, the optimal type and quantity of specific rehabilitation approaches and treatments are unknown, because acute rehabilitation has not undergone the same degree of scientific scrutiny for effectiveness as other medical therapies.15, 16, 17, 18, 19, 20 Most often studied have been rehabilitation treatments using cognitive-centered approaches because of the prominent role of cognitive impairment in TBI-related disability. Recent systematic evidence-based literature reviews21, 22 indicate fair scientific support of efficacy for several cognitive rehabilitation interventions in persons with stroke and TBI. However, most are of quasi-experimental design, are set postacutely, and/or did not address real-world effectiveness by including important functional or participation measures such as independent living and productive work. The enormous challenges of controlling for spontaneous recovery and other confounders and ethical constraints have undoubtedly limited the conduct of studies assessing cognitive strategies or other specific rehabilitation interventions during acute rehabilitation. Two quasi-experimental studies of acute TBI rehabilitation showed higher therapy intensity correlated with better outcomes but differed on which therapies mattered.23, 24 One RCT of acute cognitive rehabilitation after TBI, by Salazar et al,25 used a military sample with moderate to severe injury who had recovered to Rancho Los Amigos cognitive level of 7 (ie, oriented and appropriate) within 3 months of injury. Many of these patients would not typically receive acute comprehensive rehabilitation in the civilian sector. Although the overall results were negative, post hoc analysis revealed that subjects with more severe injury (>1h coma) had better long-term global outcomes after cognitive rehabilitation than those receiving telephone follow-up and counseling intervention, which by itself has demonstrated efficacy.26 Another RCT, by Novack et al,27 compared 2 different methods of attention training during acute rehabilitation of patients with moderate to severe TBI. No differences in short-term neuropsychologic performance or functional outcomes were found between subjects receiving 30-minute sessions daily of structured, hierarchic intervention versus nonsequential, nonhierarchic intervention. Of note, the experimental treatment approaches were isolated in modules and not integrated through the remaining 3 hours of daily therapy treatments. Thus, available data on cognitive strategies or any other specific rehabilitation interventions during acute TBI rehabilitation are scant and difficult to generalize, and further well designed studies including comparison trials are needed.18, 22 The DVBIC28 seeks to provide best treatment practices for active duty members and veterans with TBI. The objective of the current DVBIC study was to compare the effect of integrating cognitive-didactic rehabilitation versus functionally based rehabilitation activities into a conventional interdisciplinary acute TBI rehabilitation program on 1-year functioning, as measured by work status and level of independence. Both approaches promote use and practice of impaired abilities (either cognitive or functional in nature) and, if successful, both treatments involve new learning and adaptation. Therefore, forced-use and new learning are common to both approaches. However, the learning environment differed between the 2 approaches. The cognitive-didactic approach emphasized explicit learning in an environment permitting and even encouraging errors to assist clients to develop cognitive self-awareness. In addition, by targeting specific cognitive processes, this approach attempted to enhance underlying cognitive abilities. In contrast, a functional-experiential approach did not entail explicit awareness or learning, but rather emphasized motor and other forms of implicit learning. Therefore, in the functional-experiential approach, an errorless learning paradigm was used as much as possible to enhance procedural learning mechanisms. In addition, the functional approach emphasized environmental support to help brain-injured persons compensate for impaired abilities. Details of the methodology and rationale have been reported elsewhere.29 Per our review, this is the first RCT to compare different approaches to rehabilitation or schedules of treatment during acute rehabilitation. In this article, we report the results of this multicenter, parallel-group, prospective RCT comparing these 2 acute inpatient rehabilitation approaches to TBI rehabilitation in a military and veteran sample. In the absence of a nontreatment control group, this study compares these 2 rehabilitation approaches (cognitive-didactic and functional-experiential) on 1-year posttreatment global functional outcome measures (return to work and living independently). Methods  Participants All patients admitted to the CARF-accredited acute inpatient rehabilitation brain injury programs at 4 participating VAMCs (Minneapolis, Palo Alto, Richmond, and Tampa) during the study enrollment period were screened for eligibility. Inclusion criteria were (1) moderate-to-severe nonpenetrating TBI within the preceding 6 months, manifested by a postresuscitation Glasgow Coma Scale score of 12 or less, or coma of 12 hours or more, or PTA of 24 hours or more, and/or focal cerebral contusion or hemorrhage on computed tomography or magnetic resonance imaging; (2) RLAS cognitive level of 5 to 7 at time of randomization; (3) age 18 years or older; (4) active duty military member or veteran; and (6) anticipated length of needed acute interdisciplinary TBI rehabilitation of 30 days or more. Exclusion criteria were (1) history of prior inpatient acute rehabilitation for the current TBI and (2) history of a prior moderate to severe TBI or other preinjury severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury. The institutional review boards of all 4 participating VAMCs and the Uniformed Services University of the Health Sciences approved the study. All participants (or surrogates) provided written, informed consent. Figure 1 depicts patient flow. Study Design The design was a RCT with 2 treatment arms (cognitive-didactic and functional-experiential), both embedded within an interdisciplinary TBI rehabilitation program. All treatment was hospital-based. The interactive nature of the experimental conditions precluded subject blinding. Because each participating site serves a wide geographic area, the protocol permitted 1-year postprotocol treatment outcome assessments by structured telephonic interview, to minimize dropout. Participants completed baseline assessment, then received by random assignment 1 of the 2 standardized protocol rehabilitation programs (summarized below in “Study Interventions” and described in detail elsewhere).29 Baseline assessments consisted of demographic and preinjury functioning variables, injury severity characteristics, current postinjury functional capacity, and neuropsychologic functioning on those who were able to participate meaningfully in formal assessment. Study Interventions Participants received 1.5 to 2.5 hours daily of protocol-specific therapy plus another 2 to 2.5 hours daily of occupational and physical therapy. Independent teams of therapists functioned at each site to deliver the separate treatments, and by necessity were not blinded to treatment. All study therapists had at minimum several years of experience, and were certified or licensed in their respective professions (speech language therapy, occupational therapy, physical therapy, neuropsychology, or physical therapy). Protocol training occurred initially in centralized meetings, and was updated in monitoring site visits, conference calls every 2 weeks, and twice-yearly investigator meetings in order to ensure uniformity of protocol treatment over time. Cognitive-didactic treatment Appendix 1 summarizes elements of the 2 protocol treatment approaches. The cognitive-didactic protocol treatment (cognitive) implemented interventions and approaches developed by Sohlberg and Mateer30, 31, 32to target 4 cognitive domains often impaired by TBI: attention, memory, executive functions, and pragmatic communication. Subjects practiced progressively more difficult paper-and-pencil or computerized cognitive tasks in 1:1 cognitive therapy sessions (1.5–2.5h daily). A trial-and-error learning approach was used across rehabilitation therapy sessions (occupational therapy, physical therapy, speech/cognitive therapy). Therapists frequently asked questions calling attention to patients' self-awareness (eg, How do you think you did? What went wrong there? What do you need to do now?). The theoretical basis for the cognitive-didactic arm is that directly rehabilitating the cognitive deficits that underlie most functional deficits after TBI will result in a generalized functional improvement. Functional-experiential treatment The works of Giles and colleagues33, 34, 35 and Hartley36 guided the basic concepts and treatment of the functional-experiential arm (functional). The objective of the functional protocol was to use real-life performance situations and common tasks to remediate or compensate for functional deficits after brain injury. Functional protocol treatment interventions (1.5–2.5h daily) typically occurred in group settings and natural environments (hospital recreation areas, group rooms, simulated home environments in the dining room, community outings, and so forth). Treatment focused on learning-by-doing functional daily activities using an errorless treatment strategy. Therapists emphasized instructional cues and attempted to anticipate and minimize patient errors by providing structure or directions. Therapists guided patients through activities by breaking them down into component parts and adding more complex skills as simpler skills were mastered. The assumption of the functional approach was that repeated performance of real-life tasks through the use of an errorless learning approach would rebuild core functional behaviors. Differential treatment approaches throughout remaining occupational, physical, and speech therapy (2–2h daily) All treating therapists used differential intervention approaches depending on the treatment arm. In the cognitive arm, therapists questioned patients on their task performance to enhance awareness and encouraged trial-and-error problem-solving. In the functional arm, therapists provided necessary support and direction to complete tasks in an errorless learning manner. Shared program elements across both treatment arms Essential CARF standard of care interdisciplinary rehabilitation services were integrated into both treatment arms. A physiatrist was responsible for medical care and direction of the treatment team, and rehabilitation nurses provided care on the unit and assisted with basic activities of daily living and on-unit mobility. All participants received occupational and physical therapy for basic activities of daily living, range of motion, mobility, speech therapy if aphasia or dysphagic problems were present, rehabilitation counseling, TBI patient and family education, and psychologic or social work support services. Memory notebooks were maintained for all participants, but utilization approach differed between study arms, as described above in “Study Interventions.” Duration of protocol-specific intervention The protocol allowed for a range of treatment days (20–60, Monday to Friday; 26–84 calendar days) depending on the clinical needs and progress of each participant. Protocol treatment continued until participants (1) were clinically judged ready to be discharged to a home environment (with or without supervision) or to a community transitional rehabilitation program, or (2) had completed 60 days of protocol-specific treatment. If further hospitalization and interdisciplinary rehabilitation were still indicated after 60 days of protocol treatment, then participants continued to receive CARF-accredited standard of care rehabilitation (approximately 3 hours of formal therapy daily without the experimental interventions or approaches). Outcome Assessment Primary outcome measures at 1-year postprotocol treatment were functional independence (ie, ability to live independently with less than 3 hours of assistance a week) and return to work and/or school (ie, current status of paid employment or school enrollment, either full or part time, not sheltered workshop). These were determined by structured interview questions probing the amount of help received and details of any vocational activities over the year since completing the study protocol intervention. The protocol prespecified multiple secondary outcomes. The FIM37, 38 consisting of motor and cognitive scores and the DRS score39 were measured at discharge from protocol treatment, while quality of life, and psychosocial function, behavior, and mood state were measured at 1-year postprotocol treatment. The Present State Exam40 was used to capture mood and behavioral variables, the Apathy Evaluation Scale41, 42 captured motivation, and the Neurobehavioral Rating Scale43 (interview version) assessed self-perceived memory problems. Life satisfaction and change in marital status were captured by self-ratings and clinical interview, respectively. Two subset analyses were also prespecified in the protocol: analysis of treatment effects by center and baseline cognitive functioning (RLAS 5–6 vs RLAS 7). Sample Size Determination and Statistical Analyses For power calculation purposes, we estimated a 50% favorable 1-year outcome (eg, independent living status) for this population. Power analyses revealed that with a sample size of 364 participants, we would have 80% power to detect a 15% difference between the 2 arms on the primary outcomes with an α less than .05 in a 2-tailed test. The study was not powered for subset analyses, but several were planned in order to provide additional information on the usefulness of the 2 treatments for subgroups that could inform future studies. Data were analyzed using an intent-to-treat analysis including all randomized patients. All preplanned and exploratory analyses are reported. As specified in the protocol, for categorical variables including the primary outcome, contingency table analyses using the chi-square statistic were used. For continuous measures, t tests were used to compare groups. Analysis of secondary outcomes were not controlled for multiple comparisons because these were considered exploratory to guide future research. Randomization and Blinding Participants were randomized to the comparative treatments by an independent study statistician (K.S.) using random number tables. Randomization was stratified by center and blocked in randomly ordered block sizes. This method provides approximately even group assignments across centers and is recommended for multicenter clinical trials.44 Notification of treatment arm assignments occurred after consent and central confirmation of eligibility, in order to shield those enrolling participants from knowledge of the next treatment assignment. Given the interactive nature of the interventions, patients and treating clinicians could not remain blinded. However, independent evaluators collected the outcome data and were blinded to treatment arm assignment. Results Recruitment During enrollment (July 19, 1996–May 16, 2003), 476 patients out of the 897 total rehabilitation admissions fit eligibility criteria and were invited to participate. Of these, 366 subjects consented and were randomized (fig 1). Five subjects rescinded consent before study procedures began, and 1 withdrew consent later, leaving 360 subjects, 180 in each treatment arm, for the intent-to-treat sample. These were distributed among the 4 study sites as follows: Minneapolis (n=65), Palo Alto (n=91), Richmond (n=118), and Tampa (n=86). Protocol Adherence The mean ± SD duration of protocol treatment was 32.7±12.9 calendar days overall and was similar for the cognitive arm (32.2±12.2d) and functional arm (33.3±13.6d; t358=0.79, P=0.43), but it did vary over time (longer during the first half of accrual [1996–1999], 35.2±15.2 calendar days versus 29.9±8.9 calendar days; t358=4.07, P<.001). Seventy-four participants (20.6%) received less than the intended minimum 20 protocol treatment days (26 calendar days), and 3 participants (0.8%) received over the intended maximum of 60 protocol treatment days (84 calendar days). Underexposed or overexposed participants were equally distributed across the 2 arms (38 cognitive arm vs 39 functional arm). Therapist knowledge of and adherence to the differential treatment interventions were monitored qualitatively by site visits but not measured quantitatively. Baseline Data Participants' mean ± SD age was 32.4±13.2 years, 93% were men, 90% had PTA duration greater than 1 week, and only 1% had neuroimaging as their sole severity eligibility criteria. Treatment arms were similar on all baseline demographic (table 1) and injury characteristics (table 2) including age, sex, education, race, ethnicity, active military duty status, percent working prior to injury, and type and severity of brain injury. | | |  | Characteristics | Cognitive Rehabilitation | Functional Rehabilitation | Test Statistic | P | |
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| Preinjury Demographic Characteristics | | | Age (y) | 33.2±13.5 (n=180) | 31.7±12.9(n=180) | t358=1.08 | .28 | | | Education | | | χ23,n=359=6.31 | .10 | | | <12y | 8/179(4.5%) | 15/180(8.3%) | | | | | 12y (high school graduate/vocational) | 110/179(61.5%) | 98/180(54.4%) | | | | | 13–15y (some college) | 44/179(24.6%) | 57/180(31.7%) | | | | | ≥16y | 17/179(9.5%) | 10/180(5.6%) | | | | | Sex | | | χ21,N=360=1.08 | .30 | | | Men | 165/180(91.7%) | 170/180(94.4%) | | | | | Women | 15/180(8.3%) | 10/180(5.6%) | | | | | Race | | | χ22,n=357=0.19 | .91 | | | White | 121/178(68.0%) | 124/179(69.3%) | | | | | Black | 36/178(20.2%) | 33/179(18.4%) | | | | | Other⁎ | 21/178(11.8%) | 22/179(12.3%) | | | | | Hispanic ethnicity | 17/176(9.7%) | 18/171(10.5%) | χ21,n=347=0.07 | .79 | | | Marital status | | | χ22,n=347=1.72 | .42 | | | Married | 44/172(25.6%) | 44/175(25.1%) | | | | | Single | 78/172(45.3%) | 90/175(51.4%) | | | | | Separated/divorced/widowed | 50/172(29.1%) | 41/175(23.4%) | | | | | Right-handed | 165/178(92.7%) | 150/173(86.7%) | χ22,n=351=3.98 | .14 | | | Working or in school | 154/179(86.0%) | 161/180(89.4%) | χ21,n=359=0.97 | .32 | | | Active duty at time of injury | 101/173(58.4%) | 120/177(67.8%) | χ21,n=350=3.33 | .07 | | | History of prior head injury | 12/166(7.2%) | 12/167(7.2%) | χ21,n=333=0.00 | .99 | | | | |
| ⁎ Includes American Indian, Asian, and other. |
Treatment arms also were similar in baseline cognitive, physical, and neurobehavioral functioning as measured by RLAS, cognitive and motor FIM, mental status examination,45 and overall scores on the Neurobehavioral Rating Scale43 (table 3). Neuropsychologic testing measures were all at least 2 SDs below normative values and similar between groups when obtainable at baseline; 78.1% completed the Memory, Orientation, and Amnesia Test (see table 2), and 75% completed the full battery (table 4). | | | | Characteristics | Cognitive Rehabilitation | Functional Rehabilitation | Test Statistic | P | |
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| Functional Status at Time of Randomization | | | Rancho Los Amigos Cognitive Functioning Level | | | χ22,N=360=0.91 | .91 | | | V | 76/180(42.2%) | 73/180(40.6%) | | | | | VI | 66/180(36.7%) | 70/180(38.9%) | | | | | VII | 38/180(21.1%) | 37/180(20.6%) | | | | | FIM | | | | | | | Motor score, total raw score | 60.1±24.8(n=178) | 57.8±24.9(n=178) | t354=0.87 | .38 | | | Cognitive score, total raw score | 19.1±8.0(n=178) | 18.4±7.4(n=178) | t354=0.78 | .44 | | | Total score, total raw score | 79.1±31.1(n=178) | 76.2±30.7(n=178) | t354=0.89 | .37 | | | Memory, Orientation, and Amnesia score, total raw score | 74.3±23.3(n=141) | 76.1±21.9(n=131) | t279=0.67 | .51 | | | Neurobehavioral Rating Scale total score, total raw score | 52.7±16.8(n=133) | 52.7±16.4(n=130) | t261=0.01 | 1.00 | | | MMSE score, total raw score | 21.5±7.1(n=153) | 22.1±6.2(n=146) | t297=0.78 | .43 | | | | |
| | | | Neuropsychologic Test | Cognitive Rehabilitation | Functional Rehabilitation | Test Statistic | P | |
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| CVLT Learning Acquisition Sum of 5 Learning Trials (reference mean±SD, 46.2±8.8) | 26.0±11.2(n=134) | 25.5±11.8(n=134) | t266=0.33 | .74 | | | CVLT Long Delay Free Recall (total words recall out of 16) (reference mean±SD, 9.9±2.7) | 2.9±3.3(n=134) | 3.4±3.6(n=134) | t266=1.09 | .28 | | | CVLT Delay Recognition Discriminability (reference mean±SD, 91.9±6.2) | 75.8±14.0(n=134) | 74.9±15.8(n=134) | t266=0.45 | .66 | | | Wechsler Memory Scale—Revised Visual Reproduction I (reference mean±SD, 32.5±5.3) | 25.5±8.9(n=134) | 24.4±9.4(n=128) | t260=1.01 | .32 | | | Wechsler Memory Scale—Revised Visual Reproduction II (reference mean±SD, 29.5±7.1) | 14.3±11.6(n=133) | 12.1±11.2(n=127) | t258=1.52 | .13 | | | Semantic Fluency (total Animals and Supermarket items) (reference mean±SD, 41.4±10.9) | 22.0±11.1(n=132) | 21.5±10.8(n=136) | t266=0.38 | .71 | | | Lexical Fluency (total words in three 60-s trials) (reference mean±SD, 35.1±10.9) | 19.1±8.7(n=133) | 18.2±9.6(n=138) | t69=0.85 | .40 | | | Trail-Making Test Part B (total seconds to completion) (reference mean±SD, 60.6±19.6) | 154.8±78.7(n=103) | 166.5±82.2(n=105) | t206=1.04 | .30 | | | WCST Total Perseverations (reference mean ±SD, 13.0±9.1) | 35.3±27.8(n=109) | 34.4±25.8(n=107) | t214=0.26 | .80 | | | | |
Primary Outcome Measures Primary outcome measures were completed on 92% of study participants (n=331) at 1 year, most by in-person evaluations (n=238) and the remainder by structured telephonic interview. Those who completed follow-up were more educated than those who did not (t329=1.97, P=.05), but otherwise were similar on age, sex, race, and marital status. Analysis of the primary outcome measures showed no between group difference for the 2 experimental treatments at 1 year (table 5). Percent return to work or school was 38.9% for the cognitive and 35.4% for the functional arm (χ21,n=329=0.45, P=.50). Percent living independently was 56.3% for the cognitive and 61.6% for the functional arm (χ21,n=329=1.20, P=.33). These findings of comparable long-term primary outcomes between treatment arms were consistent across the 4 study sites (P>.21 in all cases). | | | | Primary Outcome Measure | Cognitive Rehabilitation | Functional Rehabilitation | Test Statistic | P | |
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| Working or in school | 65/167(38.9%) | 58/164(35.4%) | χ21,n=329=0.45 | .50 | | | Living independently | 93/167(56.3%) | 101/164(61.6%) | χ21,n=329=1.20 | .27 | | | Preplanned secondary outcome measures | | | | | | | Cognitive FIM, total raw score | 27.3±6.2(n=171) | 25.6±6.0(n=163) | t332=2.56 | .01 | | | Motor FIM, total raw score | 82.7±14.1(n=171) | 80.5±14.7(n=163) | t332=1.38 | .17 | | | DRS, total raw score | 7.6±4.8(n=152) | 8.2±5.3(n=150) | t300=1.07 | .29 | | | Satisfied with life⁎ | 80/130(61.5%) | 81/124(65.3%) | χ21,n=254=0.39 | .53 | | | Change in marital status since injury⁎ | 23/151(15.2%) | 19/150(12.7%) | χ21,n=301=0.41 | .52 | | | Social withdrawal† | | | χ22,n=273=0.49 | .78 | | | Not present during last month | 100/140(71.4%) | 90/133(67.7%) | | | | | Present less than 50% of time | 31/140(22.1%) | 34/133(25.6%) | | | | | Present more than 50% of time | 9/140(6.4%) | 9/133(6.8%) | | | | | Worrying† | | | χ22,n=274=0.18 | .91 | | | Not present during last month | 92/141(62.5%) | 88/133(66.2%) | | | | | Present less than 50% of time | 33/141(23.4%) | 32/133(24.1%) | | | | | Present more than 50% of time | 16/141(11.3%) | 13/133(9.8%) | | | | | Depressed mood† | | | χ22,n=274=1.37 | .50 | | | Not present during last month | 98/141(69.5%) | 91/133(68.4%) | | | | | Present less than 50% of time | 29/141(20.6%) | 33/133(24.8%) | | | | | Present more than 50% of time | 14/141(9.9%) | 9/133(6.8%) | | | | | Irritability† | | | χ22,n=273=1.27 | .53 | | | Not present during last month | 77/140(55.0%) | 73/133(54.9%) | | | | | Present less than 50% of time | 38/140(27.1%) | 42/133(31.6%) | | | | | Present more than 50% of time | 25/140(17.9%) | 18/133(13.5%) | | | | | Angry behavior⁎ | | | χ22,n=262=2.36 | .31 | | | Not present during last month | 49/131(37.4%) | 61/131(46.6%) | | | | | Keeps irritation to himself | 40/131(30.5%) | 36/131(27.5%) | | | | | Shows anger outwardly | 42/131(32.1%) | 34/131(26.0%) | | | | | Exploratory secondary outcome measures | | | | | | | Memory problems‡ | | | χ22,n=278=5.94 | .05 | | | None | 32/144(22.2%) | 37/134(27.6%) | | | | | Mild | 82/144(56.9%) | 57/134(42.5%) | | | | | Moderate to severe | 30/144(20.8%) | 40/134(29.9%) | | | | | Feels motivated§ | | | χ22,n=273=0.51 | .77 | | | A lot | 77/144(53.5%) | 64/129(49.6%) | | | | | Slightly/somewhat | 59/144(41.0%) | 56/129(43.4%) | | | | | Not at all | 8/144(5.6%) | 9/129(7.0%) | | | | | Get away from house⁎ | | | χ21,n=282=0.39 | .54 | | | Daily | 114/144(79.2%) | 105/138(76.1%) | | | | | Several times a week or less | 30/144(20.8%) | 33/138(23.9%) | | | | | | |
| ⁎ From clinical interview and history questions. †From the Present State Examination. ‡From the Neurobehavioral Rating Scale. §From the Apathy Evaluation Scale. |
Secondary Outcome Measures Preplanned analyses The mean ± SD cognitive FIM at the end of protocol treatment was significantly higher in the cognitive arm (27.3±6.2) than the functional (25.6±6.0; t332=2.56, P=.01),whereas both motor FIM (t332=1.38, P=.17) and DRS (t300=1.07, P=.29) were similar between treatment arms at the end of the protocol treatment. None of the additional preplanned secondary outcome measures (quality of life, psychosocial function, behavior, and mood state measures) differed at 1-year follow-up by treatment arm (see table 5). Exploratory analyses Exploratory analyses were conducted on several additional secondary outcome measures not prespecified in the protocol: self-reported memory problems, motivation, and extent of activity outside the home. Memory problems at 1-year follow-up (χ22,n=278=5.94, P=.05) differed between groups; fewer cognitive arm participants reported moderate-to-severe memory problems. Planned Subset Analyses of Primary Outcome Measures Outcomes for planned subsets of patients did not differ by treatment approach by either center or baseline RLAS (table 6). | | | | Patient Subset | Cognitive Rehabilitation | Functional Rehabilitation | Test Statistic | P | |
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| Patients Working 1 Year After Randomization | | | Center | | | | | | | Minneapolis, MN | 9/30(30.0%) | 7/32(21.9%) | χ21,n=62=0.53 | .47 | | | Palo Alto, CA | 21/44(47.7%) | 17/39(43.6%) | χ21,n=83=0.14 | .71 | | | Richmond, VA | 24/53(45.3%) | 17/50(34.0%) | χ21,n=103=1.37 | .24 | | | Tampa, FL | 11/40(27.5%) | 17/43(39.5%) | χ21,n=83=1.34 | .25 | | | Rancho level at time of randomization | | | | | | | V or VI | 48/132(36.4%) | 46/131(35.1%) | χ21,n=263=0.43 | .83 | | | VII | 17/35(48.6%) | 12/33(36.4%) | χ21,n=68=1.04 | .31 | | | Patients Living Independently 1 Year After Randomization | | | Center | | | | | | | Minneapolis, MN | 13/30(43.3%) | 17/32(53.1%) | χ21,n=62=0.59 | .44 | | | Palo Alto, CA | 23/44(52.3%) | 25/39(64.1%) | χ21,n=83=1.19 | .28 | | | Richmond, VA | 38/53(71.7%) | 37/50(74.0%) | χ21,n=103=0.69 | .79 | | | Tampa, FL | 20/40(50.0%) | 22/43(51.2%) | χ21,n=83=0.01 | .92 | | | Rancho level at time of randomization | | | | | | | V or VI | 69/132(52.3%) | 72/131(55.0%) | χ21,n=263=0.19 | .66 | | | VII | 25/35(71.4%) | 29/33(87.9%) | χ21,n=68=2.81 | .09 | | | | |
Exploratory Subset Analyses of Primary Outcome Measures Two factors that might influence primary outcomes were preselected for subset study: severity of TBI (ie, length of PTA) and premorbid academic attainment (years of education). Each factor was dichotomized (table 7) for subgroup analyses of the primary outcomes. Education level had a differential effect. The more highly educated were more often living independently at 1 year from the functional arm (69.1%) compared with the cognitive arm (47.4%; χ21,n=112=5.42, P<.02). | | | | Patient Subset | Cognitive Rehabilitation | Functional Rehabilitation | Test Statistic | P | |
|---|
| Patients Working 1 Year After Randomization | | | Length of PTA (d) | | | | | | | ≤30 | 37/78(47.4%) | 37/76(48.7%) | χ21,n=154=2.76 | .88 | | | >30 | 26/83(31.3%) | 21/81(25.9%) | χ21,n=164=0.02 | .45 | | | Education | | | | | | | ≤HS | 43/109(39.4%) | 35/109(32.1%) | χ21,n=218=1.28 | .26 | | | >HS | 22/57(38.6%) | 23/55(41.8%) | χ21,n=112=0.12 | .73 | | | Age at randomization (y) | | | | | | | ≤30 | 49/92(53.3%) | 37/98(37.8%) | χ21,n=190=4.61 | .03 | | | 30 | 16/75(21.3%) | 21/66(31.8%) | χ21,n=141=1.99 | .16 | | | Postinjury days to randomization | | | | | | | ≤42 | 45/83(54.2%) | 40/77(51.9%) | χ21,n=160=0.83 | .77 | | | >42 | 20/84(23.8%) | 18/87(20.7%) | χ21,n=171=0.24 | .62 | | | Patients Living Independently 1 Year After Randomization | | | Length of PTA (d) | | | | | | | ≤30 | 56/78(71.8%) | 59/76(77.6%) | χ21,n=154=0.69 | .41 | | | >30 | 34/83(41.0%) | 39/81(48.1%) | χ21,n=164=0.86 | .36 | | | Education | | | | | | | ≤HS | 67/109(61.5%) | 63/109(57.8%) | χ21,n=218=0.31 | .58 | | | >HS | 27/57(47.4%) | 38/55(69.1%) | χ21,n=112=5.42 | .02 | | | Age at randomization (y) | | | | | | | ≤30 | 62/92(67.4%) | 62/98(63.3%) | χ21,n=190=0.36 | .55 | | | >30 | 32/75(42.7%) | 39/66(59.1%) | χ21,n=141=3.79 | .05 | | | Postinjury days to randomization | | | | | | | ≤42 | 59/83(71.1%) | 61/77(79.2%) | χ21,n=160=1.41 | .24 | | | >42 | 35/84(41.7%) | 40/87(46.0%) | χ21,n=171=0.32 | .57 | | | Cognitive FIM Change Score: From Randomization to End of Protocol Treatment | | | Baseline cognitive FIM, raw total score | | | | | | | 5–18 | 12.7±7.1 | 10.3±5.1 | t163=2.53 | .02 | | | 19–35 | 4.9±4.3 | 4.5±4.7 | t163=0.57 | .57 | | | | |
Additional confounder analyses were conducted for age and days from injury to protocol treatment. Both factors were dichotomized, and subgroup analyses were performed (see table 7). Age showed a differential effect for both outcomes, whereas days from injury showed no influence. Younger participants were more often working at 1 year posttreatment if they received cognitive (53.3%) rather than functional rehabilitation (37.8%; χ21,n=190=4.61, P<.03). In contrast, the older group more often achieved independent living status at 1 year posttreatment if they received functional (59.1%) versus cognitive rehabilitation (42.7%; χ21,N=141=3.79, P<.05). An additional analysis was conducted in order to determine whether there were cohort effects over the course of the study. Subjects recruited between 1996 and 1999 were compared with subjects recruited from 2000 until the end of the study. The results of the efficacy analysis on the 2 primary outcome measures did not differ for these 2 subject cohorts, suggesting that the period of time did not affect subjects' differential response to the 2 treatment arms. Exploratory Subset Analyses of the FIM Given the differences found in cognitive FIM outcome, we also examined the cognitive FIM change scores from beginning to end of protocol treatment. This analysis was done separately for persons who started with lower (5–18) versus higher (19–35) pretreatment cognitive FIM scores because FIM scores tend to have a ceiling effect limiting responsiveness for higher initial FIM scores. A beneficial effect of cognitive over functional rehabilitation was found in those who began treatment with lower cognitive FIM scores. The mean ± SD of cognitive FIM change was significantly higher in the cognitive arm (12.7±7.1) than the functional (10.3±5.1; t163=2.53, P<.02). Given that the cognitive FIM range is 30, this represents an overall differential benefit of 12.5% in cognitive independence in the cognitive arm participants. Adverse Events No serious adverse events attributable to the protocol interventions were identified. Discussion This study is the first randomized clinical head-to-head comparison of 2 acute inpatient interdisciplinary rehabilitation approaches to treating moderate to severe TBI. The competing treatment approaches, cognitive versus functional, were concurrently implemented in a large military and veteran sample using independent teams to maintain treatment purity. The primary outcomes were 1-year global functional measures rather than short-term impairment-based measures and did not differ between groups. Both of these treatment approaches have shown efficacy in previous studies,22, 33, 46, 47, 48 and the results of the current study also show long-term functional improvements within both groups. At 1 year postinjury, the overall rates of independent living and employment and/or student status were 58.9% and 37.2%, respectively. This is remarkable given that none were capable of work or independent living at baseline, 90% had severe TBIs (length of PTA greater than a week), and pretreatment neuropsychologic performance averaged more than 2 SDs under normative performance levels. Thus, primary outcomes imply that both interventions confer benefit, although natural recovery influences are entangled because we deemed nonrehabilitation controls unethical. Analysis of secondary cognitive outcomes showed a differential benefit for the cognitive treatment arm. Subjects in the cognitive arm had higher cognitive FIM scores at the completion of treatment, and those most impaired at baseline also showed differential improvement in cognitive FIM. Moreover, cognitive arm participants reported lower rates of memory problems at 1-year follow-up. Practice effect does not explain these differences because these outcome measures are very different from the actual cognitive interventions, which consisted of paper-and-pencil and computerized tasks of cognition in a didactically based trial-and-error learning setting. Thus, these better day-to-day functional measures of cognition reflect beneficial generalization of the didactic-based cognitive approach. This is the first study that shows an effect of cognitive rehabilitation interventions during the acute phase of rehabilitation in persons with severe brain injuries, most of whom were still in a posttraumatic confusional state (Rancho level VI or less) when protocol-based cognitive interventions began. Exploratory subgroup analyses found that younger participants in the cognitive arm had a higher rate of returning to work or school than younger patients in the functional arm. In contrast, participants older than 30 years and those with more years of education in the functional arm had higher rates of independent living status at 1 year posttreatment than similar patients in the cognitive arm. Taken together these findings suggest that the cognitive treatment not only better enhances cognitive recovery but also lays a stronger foundation for the development of work-related cognitive skills. This effect appears to be most prominent in younger patients who may benefit more from the higher level of structure and teaching provided in the cognitive approach to treatment. The functional approach generally provided less structure and did not offer problem-solving strategies and approaches. Older or more educated persons, who may already have internalized structure and independence, seemed to benefit more from the direct living skills training emphasized in the functional interventions. However, these interpretations should be considered tentative because they were derived from ad hoc subset analyses and await prospective confirmation. The current study is 1 of only a few large-sample RCTs in TBI rehabilitation; most TBI rehabilitation studies are based on small convenience samples. In part this is because large-sample RCTs in rehabilitation are resource-intensive and expensive. To have sufficient power to investigate treatment efficacy, this study required participant enrollment across 4 sites and 7 years. Also, TBI is a complex condition with multiple cognitive and physical problems that vary significantly in pattern and severity across patients. Because of this, some advocate case studies31, 47, 48 or focused rehabilitation trials with small homogenous samples.49 However, because TBI is a condition in which the natural course is improvement, case studies generally cannot provide strong evidence of efficacy without a control group. In addition, generalization across different TBI samples is much more difficult from case studies or small homogenous samples than from RCTs. Our success in completing this RCT suggests the field of rehabilitation has developed to the point that efficacy studies of comprehensive treatment approaches and long-term functional outcomes are possible. However, global outcomes such as return to work are not unitary. Different jobs have very different cognitive and physical requirements. Furthermore, there are numerous potential obstacles to working successfully, including cognitive, physical, or behavioral impairments, various combinations thereof, and non-TBI related factors such as inexperience, limited education, and lack of transportation. Consistent with these confounds, the present study's comparisons of various subgroups and analyses of secondary outcomes provided some initial determinations of which treatments have efficacy for different subgroups, specific problems, or desired outcomes. Age and education appear to play important and perhaps interactive roles with divergent treatments, either as independent variables or as markers for person-specific characteristics such as preinjury internalized problem-solving strategies, achievement orientation, and independent mindedness. These findings may help guide different intervention approaches. For older persons with a focus on independent functioning and not necessarily return to work, the functional approach may be more effective. In contrast, for younger persons or cases in which a return to work is a major focus, a cognitive approach should be considered. These hypotheses deserve further empirical exploration. Study Limitations Our study has limitations. First, although the cognitive and the functional approaches were based on divergent rehabilitation strategies and learning theories, these 2 approaches had overlap. Both arms used compensatory techniques, although more heavily in the functional arm. By design and because of standards of care issues, use of memory notebooks also was common to both approaches. Therapists in the cognitive arm used memory notebooks as a training tool to build awareness of memory deficits and assist participants in using it as a problem-solving tool. In contrast, therapists in the functional arm simply employed memory notebooks as a day-to-day functional compensatory technique. These types of overlap between the 2 treatment arms may have minimized the ability to find differential outcomes. In addition, the global primary outcome measures of return to work and ability to live independently are multiply determined and are not specifically dependent on either a cognitive or a functional treatment approach. Many intervening events transpired during the 1 year between completion of the protocol interventions and these measures, including additional outpatient therapy for many. Although discharge recommendations were made that further treatment continue with similar approaches for the randomized patients, cognitive versus functional, this was not controlled. These factors minimize the likelihood of finding potential group differences between study arms. Future studies should consider assessing functional outcomes at 6 months and 12 months after treatment. In addition, consideration should be given to other types of measures such as ecologically valid measures of executive and other cognitive abilities. Our goal to evaluate the overall effectiveness of these 2 comprehensive treatment approaches on important functional life activities was perhaps overly ambitious. Other limitations are that multiple secondary and subanalyses were conducted without adjustment for multiple comparisons, so some findings may be spurious. Also, the sample was composed primarily of male subjects (93%). Thus, findings may not generalize to female subjects. Despite our best efforts, approximately 8% of the sample was lost to follow-up, and primary outcomes were not obtained. However, these participants were equally divided between the 2 treatment arms, and their absence is unlikely to affect any of the outcomes obtained in this study. Conclusions The results from this trial, with the largest sample ever treated in a randomized controlled rehabilitation trial of TBI, indicated no difference between cognitive-didactic and functional-experiential approaches to brain injury rehabilitation on the primary 1-year global outcome measures of the study. However, patients in the cognitive treatment arm had better posttreatment cognitive performance than patients in the functional treatment arm. In addition, subgroup analyses found that younger participants benefited more from cognitive treatment in terms of return to work or school, while older participants and those with more education benefited more from functional treatment in terms of independent living status. Additional prospective research designed to investigate the effectiveness of these therapies on these and other subsets of the TBI patient population would be useful. Acknowledgments We thank the Defense and Veterans Brain Injury Center Study Group. Minneapolis VAMC: Barbara Sigford, MD, PhD, Rose Collins, PhD, Richard A. Lanham Jr, PhD, Jeanne Lojovich, PT, NCS, Donald MacLennan, MA, CCC/SLP, Michelle Peterson, DPT, NCS, Deborah Voydetich, OTR. Palo Alto VAMC: Elaine S. Date, MD, Rex A. Bierley, PhD, John H. Poole, PhD, Jill Storms, OTR/L, Sarah Eggen Thornhill, OTR/L, Rose Marie Salerno, RN. Richmond VAMC: William Walker, MD, Tripti Jena, MD, Micaela Cornis-Pop, PhD, CCC-SLP, John House, PhD, Ron Seel, PhD, Jame T. Magee, BS, Patricia Baggett, MEd, LaVerne Budd, MS. Tampa VAMC: Steven G. Scott, DO, Joel D. Scholten, MD, Rodney D. Vanderploeg, PhD, Glenn Curtiss, PhD, Linda M. Picon, MCD, CCC/SLP, Kathryn Kieffer, MCD, CCC/SLP. Walter Reed Army Medical Center/DVBIC Headquarters: Deborah L. Warden, MD, Andres M. Salazar, MD, Karen Schwab, PhD, Jamie A. Fraser, MPH. We thank Ralph Frankowski, PhD, for statistical consultation, and John Whyte, MD, PhD, and Jeffery Barth, PhD, for helpful comments on the manuscript. The opinions or assertions contained herein are the private views of the authors and are not to be construed as official, or as reflecting the views of the Department of the Army, the Department of Defense, or the Department of Veterans Affairs. 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49. 49Barrett AM, Levy CR, Gonzalez-Rothi LJ. Treatment innovation in the rehabilitation of cognitive and motor deficits after stroke and brain injury. Am J Phys Med Rehabil. 2007;6:423–425. a Department of Mental Health and Behavioral Sciences, and Defense and Veterans Brain Injury Center, James A. Haley Veterans Affairs Medical Center, Tampa, FL b Department of Psychiatry and Behavioral Medicine, University of South Florida, Tampa, FL c Department of Psychology, University of South Florida, Tampa, FL d Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC e Uniformed Services University of the Health Sciences, Bethesda, MD f Defense and Veterans Brain Injury Center, Hunter H. McGuire Veterans Affairs Medical Center, Richmond, VA g Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University School of Medicine, Richmond, VA h Physical Medicine and Rehabilitation, Minneapolis Veterans Affairs Medical Center, Minneapolis, MN; and Defense and Veterans Brain Injury Center i Comprehensive Rehabilitation Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA; and Defense and Veterans Brain Injury Center j Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA k Physical Medicine and Rehabilitation Service; Polytrauma Rehabilitation Center, James A. Haley Veterans Affairs Medical Center, Tampa, FL; and Defense and Veterans Brain Injury Center l Physical Medicine and Rehabilitation Section, Department of Internal Medicine, University of South Florida College of Medicine, Tampa, FL m Oncovir Inc, Washington, DC  Reprint requests to Rodney D. Vanderploeg, PhD, Mental Health and Behavioral Sciences—Psychology (116B), James A. Haley VAMC, 13000 N. Bruce B. Downs Blvd, Tampa, FL, 33612
Supported by the Defense and Veterans Brain Injury Center, Uniformed Services University of the Health Sciences, Bethesda, MD, the Department of Veterans Affairs, Veterans Health Administration, and a Department of Defense award administered through the Henry Jackson Foundation (grant no. MDA 905-03-2-0003). No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. PII: S0003-9993(08)01485-8 doi:10.1016/j.apmr.2008.06.015 Published by Elsevier Inc. | |
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