Self-Management for Amputee Rehabilitation Using Technology

Study Overview
=================
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.

Official Title
-----------------
Self-Management for Amputee Rehabilitation Using Technology (SMART) Phase 2

Conditions
-----------------
Unilateral Trans Tibial/Femoral Lower Limb Amputation

Intervention / Treatment
-----------------
* Device: Self-Management for Amputee Rehabilitation using Technology [SMART]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 1) people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMART & Peer Support<br> | Device: Self-Management for Amputee Rehabilitation using Technology [SMART]<br>* Participants will complete a 6-week tablet-based education program for individuals with LLA that will provide them with self-management education.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up & Go Test (TUG) | Functional assessment of walking capacity measured in seconds over 3 meters walkway | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory Self-Confidence Questionnaire (ASCQ) | 22-item questionnaire where participants are asked to rate questions on a scale from 0 (not confident at all) to 10( extremely confident) | 6 weeks | 
| The Center for Epidemiologic Studies Depression Scale (CES-D) | Self-rating measure assessing depression, with final scores ranging from 0 to 60, with total score above 23 indicating clinical depression | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Occupational Therapy, Rehabilitation, Lower-Limb Amputations, Amputees, Telehealth, Remote Rehabilitation, Telerehabilitation, E-learning, Education, Self-Management, Ambulation, Coping Strategies, Outcomes, Prevalence