Abstract
Objective
To quantify the long-term (>2y) effects of lower extremity (LE) neuroprostheses (NPs)
for standing, transfers, stepping, and seated stability after spinal cord injury.
Design
Single-subject design case series with participants acting as their own concurrent
controls, including retrospective data review.
Setting
Hospital-based clinical biomechanics laboratory with experienced (>20y in the field)
research biomedical engineers, a physical therapist, and medical monitoring review.
Participants
Long-term (6.2±2.7y) at-home users (N=22; 19 men, 3 women) of implanted NPs for trunk
and LE function with chronic (14.4±7.1y) spinal cord injury resulting in full or partial
paralysis.
Interventions
Technical and clinical performance measurements, along with user satisfaction surveys.
Main Outcome Measures
Knee extension moment, maximum standing time, body weight supported by lower extremities,
3 functional standing tasks, 2 satisfaction surveys, NP usage, and stability of implanted
components.
Results
Stimulated knee extension strength and functional capabilities were maintained, with
94% of implant recipients reporting being very or moderately satisfied with their
system. More than half (60%) of the participants were still using their implanted
NPs for exercise and function for >10min/d on nearly half or more of the days monitored;
however, maximum standing times and percentage body weight through LEs decreased slightly
over the follow-up interval. Stimulus thresholds were uniformly stable. Six-year survival
rates for the first-generation implanted pulse generator (IPG) and epimysial electrodes
were close to 90%, whereas those for the second-generation IPG along with the intramuscular
and nerve cuff electrodes were >98%.
Conclusions
Objective and subjective measures of the technical and clinical performances of implanted
LE NPs generally remained consistent for 22 participants after an average of 6 years
of unsupervised use at home. These findings suggest that implanted LE NPs can provide
lasting benefits that recipients value.
Keywords
List of abbreviations:
IPG (implanted pulse generator), LE (lower extremity), NP (neuroprosthesis), QUEST (Quebec User Evaluation of Satisfaction with assistive Technology), SCI (spinal cord injury), SCS (spinal cord stimulation), UE (upper extremity)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: September 09, 2017
Footnotes
Supported by the Department of Veterans Affairs, Veterans Health Administration, Rehabilitation Research and Development Service (award no. A9259-L, project no. B7368-R); the Advanced Platform Technology Center; the National Institute of Neurological Disorders and Stroke, National Institutes of Health (grant no. NS-040547); and the National Institute on Biomedical Imaging and Bioengineering, National Institutes of Health (grant no. EB001889).
The contents do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.
Clinical Trial Registration Nos.: NCT00004445, NCT00623389, NCT01474148, and NCT01570816.
Disclosures: none.
Identification
Copyright
Published by Elsevier Inc. on behalf of the American Congress of Rehabilitation Medicine
