Ignite Creation Date:
2024-05-06 @ 1:47 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04120038
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2019-10-07
Brief Title:
Self-Management for Amputee Rehabilitation Using Technology
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Self-Management for Amputee Rehabilitation Using Technology SMART Phase 2
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART
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 nutritionweight 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None