Collaborative-care Rehabilitation After Dysvascular Amputation

Overview

The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.

Full Title of Study: “Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 27, 2017

Interventions

  • Behavioral: Exercise
    • Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
  • Behavioral: Walking Program
    • A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
  • Behavioral: Health Self-Management Support
    • Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.

Arms, Groups and Cohorts

  • Experimental: Exercise, activity, and self-management
    • Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
  • No Intervention: Home and phone visit
    • No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.

Clinical Trial Outcome Measures

Primary Measures

  • Timed Up-and-Go Test
    • Time Frame: Baseline, 12-weeks, and 24 weeks
    • Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.

Secondary Measures

  • Two-Minute Walk Test
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
  • Five Meter Walk Test
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Performance-based physical function test measures the time to walk 5 meters at the participant’s “normal, everyday pace”.
  • Prosthesis Evaluation Questionnaire – Mobility Section
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.
  • Houghton Scale
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.
  • Patient-Specific Function Scale
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.
  • Physical Activity Step Counts
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Instrumented physical activity measure, average step counts per day
  • Self-Efficacy in Managing Chronic Disease Questionnaire
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.
  • World Health Organization Disability Assessment Scale
    • Time Frame: Baseline, 12 weeks, and 24 weeks
    • Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).

Participating in This Clinical Trial

Inclusion Criteria

1. Diabetes and/or Peripheral Artery Disease 2. Unilateral transtibial amputation < 6 months prior to screening 3. Household ambulation using definitive prosthesis prior to baseline testing 4. Participation in physical rehabilitation at time of baseline testing 5. Live within 45 minutes of a participating clinic Exclusion Criteria:

1. Require wheelchair for mobility (use prosthesis for transfers only) 2. Ankle-level or above amputation on contralateral limb 3. Traumatic or cancer-related amputation 4. Uncontrolled heart condition 5. Acute systemic infection 6. Pregnancy 7. Decisionally challenged 8. Prisoners

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cory L Christiansen, PT, PhD, Principal Investigator, University of Colorado, Denver

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.