Self-Management for Amputee Rehabilitation Using Technology.

NCT04953364 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Behavior
  • Amputation
  • Lower Limb Amputation Above Knee (Injury)
  • Lower Limb Amputation Below Knee (Injury)
  • Lower Limb Amputation Knee

Interventions

BEHAVIORAL

SMART

SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. The tablet will also allow asynchronous contact with trainers through a secure website.

BEHAVIORAL

Control

The control group will receive a care booklet and weekly contacts for 6 weeks.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • University of British Columbia

    lead OTHER

Principal Investigators

  • William C Miller, PhD · The University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2025-01-01
Completion
2026-02-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04953364 on ClinicalTrials.gov