Collaborative-care Rehabilitation After Dysvascular Amputation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01929018|
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Complications Peripheral Arterial Disease||Behavioral: Exercise Behavioral: Walking Program Behavioral: Health Self-Management Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation|
|Actual Study Start Date :||October 9, 2013|
|Actual Primary Completion Date :||March 27, 2017|
|Actual Study Completion Date :||June 29, 2017|
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.
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.
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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929018
|United States, Colorado|
|University of Colorado Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Cory L Christiansen, PT, PhD||University of Colorado, Denver|