Collaborative-care Rehabilitation After Dysvascular Amputation

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Diabetes Complications
• Interventions: Behavioral: Exercise; Behavioral: Walking Program; Behavioral: Health Self-Management Support

• Registration Number: NCT01929018
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-27
• Study Start: 2013-10-09
• Primary Completion: 2017-03-27
• Study Completion: 2017-06-29
• Results First Submitted: 2018-05-29
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-18
• Last Update Submitted: 2019-07-18
• Results First Posted: 2019-08-14
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise, activity, and self-management	Health Self-Management Support	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.
Exercise, activity, and self-management	Exercise	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.
Exercise, activity, and self-management	Walking Program	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.

Primary Outcome Measures

Name	Time	Method
Timed Up-and-Go Test	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 Outcome Measures

Name	Time	Method
Five Meter Walk Test	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	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.
Physical Activity Step Counts	Baseline, 12 weeks, and 24 weeks	Instrumented physical activity measure, average step counts per day
World Health Organization Disability Assessment Scale	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).
Two-Minute Walk Test	Baseline, 12 weeks, and 24 weeks	Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
Patient-Specific Function Scale	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.
Self-Efficacy in Managing Chronic Disease Questionnaire	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.
Houghton Scale	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.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States