Collaborative-care Rehabilitation After Dysvascular Amputation

Peripheral Arterial Disease Clinical Trial

Official title:

Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929018
• Other study ID #: 13-0179
• Status: Completed
• Phase: N/A
• Start date: October 9, 2013
• Est. completion date: June 29, 2017

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 29, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Exercise
Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
• 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.
• Health Self-Management Support
Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Physical Activity Step Counts	Instrumented physical activity measure, average step counts per day	Baseline, 12 weeks, and 24 weeks
Secondary	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
Secondary	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