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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
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 will be delivered with weekly meetings between the researcher and participant over a 12-week period.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
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.
Time frame: Baseline, 12-weeks, and 24 weeks
Two-Minute Walk Test
Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Baseline, 12 weeks, and 24 weeks
Physical Activity Step Counts
Instrumented physical activity measure, average step counts per day
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 12 weeks, and 24 weeks