Self-Management for Amputee Rehabilitation Using Technology
- Conditions
- Unilateral Trans Tibial/Femoral Lower Limb Amputation
- Interventions
- Device: Self-Management for Amputee Rehabilitation using Technology [SMART]
- Registration Number
- NCT04120038
- Lead Sponsor
- University of British Columbia
- Brief Summary
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.
- Detailed Description
Participants will receive an online link to access the SMART platform. Online training on using the SMART platform will be provided for participants. Participants will be asked to complete one education module per week at their own convenience and weekly online meetings with a peer over the 6-week intervention period. The educational modules include psychological adaptation, residual limb management, nutrition/weight control, managing a prosthetic limb, managing chronic conditions and enhancing mobility. The modules include instructional movies, goal setting logs, and quizzes. A module can be stopped or "re-wound" at any point, and the participant's place and work-to-date is automatically saved. The SMART platform will be asynchronously monitored through a web portal by the trainer, who will be a PhD candidate in Rehabilitation Sciences and observe participant progress and provide feedback if required. If there is no online activity within a 7-day (consecutive) period, the trainer will contact the participant to inquire the reasons for inactivity and troubleshoot any problems including technical issues. Clinical outcomes measures will be collected at two timepoints (T1 \& T2). A post-intervention one on one interview will be conducted to explore SMART acceptability.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- adults who are 19 years of age or older.
- individuals who are post unilateral transtibial/transfemoral amputation and casted an initial prosthesis within the past year.
- English speaking.
- living in British Columbia or Ontario, Canada.
- have access to an internet connectable device (e.g., computer or tablet)
- people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SMART & Peer Support Self-Management for Amputee Rehabilitation using Technology [SMART] -
- Primary Outcome Measures
Name Time Method Timed Up & Go Test (TUG) 6 weeks Functional assessment of walking capacity measured in seconds over 3 meters walkway
- Secondary Outcome Measures
Name Time Method Ambulatory Self-Confidence Questionnaire (ASCQ) 6 weeks 22-item questionnaire where participants are asked to rate questions on a scale from 0 (not confident at all) to 10( extremely confident)
The Center for Epidemiologic Studies Depression Scale (CES-D) 6 weeks Self-rating measure assessing depression, with final scores ranging from 0 to 60, with total score above 23 indicating clinical depression
Trial Locations
- Locations (1)
GF Strong Rehabilitation Centre
🇨🇦Vancouver, British Columbia, Canada