NCT04120038|Completed
Self-Management for Amputee Rehabilitation Using Technology
SMART
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SMART
Sponsor study identifier
interventional
12
1 country
1
Study Start
January 26, 2021
Actual (reported)Primary Completion
August 31, 2021
Actual (reported)Study Completion
August 31, 2021
Actual (reported)The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the walking capacity and confidence of individuals with unilateral lower limb amputation (LLA). Our primary hypothesis is that SMART can improve walking capacity in individuals with LLA. Our secondary hypothesis is that SMART can improve ambulation confidence, body function, depression, body image, pain, balance confidence, activities of daily living, satisfaction with life and habit formation for skin monitoring and prosthetic cleaning in individuals with LLA. A post-intervention one on one interview will be conducted to understand SMART acceptability. The entirety of the study, including intervention administration, assessment, and interviews will be conducted online.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2019
Actual (reported)October 9, 2019
Actual (reported)January 26, 2021
Actual (reported)August 31, 2021
Actual (reported)August 31, 2021
Actual (reported)Timed Up & Go Test (TUG)
Functional assessment of walking capacity measured in seconds over 3 meters walkway
6 weeks
Ambulatory Self-Confidence Questionnaire (ASCQ)
6 weeks
The Center for Epidemiologic Studies Depression Scale (CES-D)
6 weeks
Participants will complete a 6-week tablet-based education program for individuals with LLA that will provide them with self-management education.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z2G9, Canada
B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
William C Miller, PhD
University of British Columbia
12 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2019
First Posted
October 9, 2019
Study Start
January 26, 2021
Actual (reported)Revised Amputee Body Image Scale (ABIS-R)
6 weeks
Pain Questionnaire
6 weeks
Activities Specific Balance Confidence Scale (ABC).
6 weeks
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2021
Actual (reported)Study Completion
August 31, 2021
Actual (reported)Last Updated
October 15, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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