Original article| Volume 93, ISSUE 11, P2075-2079, November 2012

New Monitoring Technology to Objectively Assess Adherence to Prescribed Footwear and Assistive Devices During Ambulatory Activity


      Bus SA, Waaijman R, Nollet F. New monitoring technology to objectively assess adherence to prescribed footwear and assistive devices during ambulatory activity.


      To assess the validity and feasibility of a new temperature-based adherence monitor to measure footwear use.


      Observational study.


      University medical center and participants' homes.


      Convenience sample of healthy subjects (n=11) and neuropathic diabetic patients at high risk for foot ulceration (n=14).


      In healthy subjects, the validity of the in-shoe attached adherence monitor was investigated by comparing its registrations of donning and doffing of footwear during 7 days to an accurately kept log registration. In diabetic patients, the feasibility of using the adherence monitor for 7 days in conjunction with a time-synchronized ankle-worn step activity monitor to register prescribed footwear use during walking was assessed. Furthermore, a usability questionnaire was completed.

      Main Outcome Measures

      For validity, the mean time difference and 95% confidence interval (CI) between moments of donning/doffing footwear recorded with the adherence monitor and in the log were calculated. For feasibility, technical performance, usability, and the percentage of steps that the footwear was worn (adherence) were assessed.


      The mean time difference between the adherence monitor and log recordings was 0.4 minutes (95% CI, 0.2–0.6min). One erroneous recording and 2 incomplete recordings were obtained in diabetic patients. Three patients reported discomfort with the step activity monitor, and 4 patients would not favor repeated testing. Patients used their footwear for between 9% and 99% of their walking steps.


      The adherence monitor shows good validity in measuring when footwear is used or not, and is, together with instrumented monitoring of walking activity, a feasible and objective method to assess treatment adherence. This method can have wide application in clinical practice and research regarding prescribed footwear and other body-worn assistive devices.

      Key Words

      List of Abbreviations:

      CI (confidence interval)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Archives of Physical Medicine and Rehabilitation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Knowles E.A.
        • Boulton A.J.
        Do people with diabetes wear their prescribed footwear?.
        Diabet Med. 1996; 13: 1064-1068
        • Macfarlane D.J.
        • Jensen J.L.
        Factors in diabetic footwear compliance.
        J Am Podiatr Med Assoc. 2003; 93: 485-491
        • Armstrong D.G.
        • Lavery L.A.
        • Kimbriel H.R.
        • Nixon B.P.
        • Boulton A.J.
        Activity patterns of patients with diabetic foot ulceration: patients with active ulceration may not adhere to a standard pressure off-loading regimen.
        Diabetes Care. 2003; 26: 2595-2597
        • Armstrong D.G.
        • Nguyen H.C.
        • Lavery L.A.
        • van Schie C.H.
        • Boulton A.J.
        • Harkless L.B.
        Off-loading the diabetic foot wound: a randomized clinical trial.
        Diabetes Care. 2001; 24: 1019-1022
        • Helfenstein A.
        • Lankes M.
        • Ohlert K.
        • et al.
        The objective determination of compliance in treatment of adolescent idiopathic scoliosis with spinal orthoses.
        Spine (Phila Pa 1976). 2006; 31: 339-344
        • Hommel K.A.
        • Davis C.M.
        • Baldassano R.N.
        Objective versus subjective assessment of oral medication adherence in pediatric inflammatory bowel disease.
        Inflamm Bowel Dis. 2009; 15: 589-593
        • LaFleur J.
        • Oderda G.M.
        Methods to measure patient compliance with medication regimens.
        J Pain Palliat Care Pharmacother. 2004; 18: 81-87
        • Takemitsu M.
        • Bowen J.R.
        • Rahman T.
        • Glutting J.J.
        • Scott C.B.
        Compliance monitoring of brace treatment for patients with idiopathic scoliosis.
        Spine (Phila Pa 1976). 2004; 29: 2070-2074
        • Hunter L.N.
        • Sison-Williamson M.
        • Mendoza M.M.
        • et al.
        The validity of compliance monitors to assess wearing time of thoracic-lumbar-sacral orthoses in children with spinal cord injury.
        Spine (Phila Pa 1976). 2008; 33: 1554-1561
        • Havey R.
        • Gavin T.
        • Patwardhan A.
        • et al.
        A reliable and accurate method for measuring orthosis wearing time.
        Spine (Phila Pa 1976). 2002; 27: 211-214
        • Crews R.T.
        • Armstrong D.G.
        • Boulton A.J.
        A method for assessing off-loading compliance.
        J Am Podiatr Med Assoc. 2009; 99: 100-103
        • Altman D.G.
        Practical statistics for medical research.
        Chapman and Hall, London1999
        • Crews R.T.
        • Bowling F.L.
        • Boulton A.J.
        Controversies in off-loading: should big brother be watching?.
        Curr Diab Rep. 2009; 9: 417-419