Collaborative-care Rehabilitation After Dysvascular Amputation

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation

Conditions
-----------------
Diabetes Complications, Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Walking Program
* Behavioral: Health Self-Management Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes and/or Peripheral Artery Disease Unilateral transtibial amputation < 6 months prior to screening Household ambulation using definitive prosthesis prior to baseline testing Participation in physical rehabilitation at time of baseline testing Live within 45 minutes of a participating clinic Exclusion Criteria: Require wheelchair for mobility (use prosthesis for transfers only) Ankle-level or above amputation on contralateral limb Traumatic or cancer-related amputation Uncontrolled heart condition Acute systemic infection Pregnancy Decisionally challenged Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise, activity, and self-management<br>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. | Behavioral: Exercise<br>* Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.<br>Behavioral: Walking Program<br>* A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.<br>Behavioral: Health Self-Management Support<br>* Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.<br>|
| No Intervention: Home and phone visit<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up-and-Go Test | 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. | Baseline, 12-weeks, and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-Minute Walk Test | Performance-based physical function test measures total number of meters walked in two minutes on a level walkway. | Baseline, 12 weeks, and 24 weeks | 
| Five Meter Walk Test | Performance-based physical function test measures the time to walk 5 meters at the participant's normal, everyday pace. | Baseline, 12 weeks, and 24 weeks | 
| Prosthesis Evaluation Questionnaire - Mobility Section | 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. | Baseline, 12 weeks, and 24 weeks | 
| Houghton Scale | 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. | Baseline, 12 weeks, and 24 weeks | 
| Patient-Specific Function Scale | 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. | Baseline, 12 weeks, and 24 weeks | 
| Physical Activity Step Counts | Instrumented physical activity measure, average step counts per day | Baseline, 12 weeks, and 24 weeks | 
| Self-Efficacy in Managing Chronic Disease Questionnaire | 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. | Baseline, 12 weeks, and 24 weeks | 
| World Health Organization Disability Assessment Scale | 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). | Baseline, 12 weeks, and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amputation, Rehabilitation, Exercise, Movement