NCT04953364 Self-Management for Amputee Rehabilitation Using Technology.
| NCT ID | NCT04953364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-10-14 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2022-10-14 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee amputation.
Eligibility Criteria
Inclusion Criteria: * Has a unilateral LLA (transtibial or transfemoral) due to diabetes or vascular disease * Received initial casting of their prosthesis within the past 2 years * Be aged ≥ 50 years (85% of adults with LLA) * Self-identifies as being able to speak and read English. * Has access to computer or tablet and internet. * Individuals living in British Columbia or Ontario, Canada. Exclusion Criteria: * Substantial health conditions (e.g., congestive heart failure, diagnosed dementia) * Those anticipating further surgery (e.g. LLA revision) as identified by our study sites' physiatrists * an inability to use a tablet (e.g. using hands for typing).
Contact & Investigator
William C Miller, PhD
PRINCIPAL INVESTIGATOR
The University of British Columbia
Frequently Asked Questions
Who can join the NCT04953364 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04953364 currently recruiting?
Yes, NCT04953364 is actively recruiting participants. Contact the research team at bill.miller@ubc.ca for enrollment information.
Where is the NCT04953364 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT04953364 clinical trial?
NCT04953364 is sponsored by University of British Columbia. The principal investigator is William C Miller, PhD at The University of British Columbia. The trial plans to enroll 82 participants.