Recruiting

Amputee Rehabilitation

Sponsor:

University of British Columbia

Code:

NCT04953364

Conditions

Behavior

Amputation

Lower Limb Amputation Above Knee (Injury)

Lower Limb Amputation Below Knee (Injury)

Lower Limb Amputation Knee

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

SMART

Control

Study Details

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.

Conditions

Behavior

Amputation

Lower Limb Amputation Above Knee (Injury)

Lower Limb Amputation Below Knee (Injury)

Lower Limb Amputation Knee

Study ID

NCT04953364

Start date

Oct 14, 2022

Status verified date

Jul, 2024

Completion date

Feb 1, 2026

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: SMART

The experimental group will receive access to SMART online platform (6 weeks). 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. SMART will also allow asynchronous contact with trainers through a secure website.

active comparator: Control

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

Interventions

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.

Control

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

Primary outcome measure

  • TUG, Timed Up and Go test [ Time Frame: Ten weeks ]
  • ASCQ, the Ambulatory Self-Confidence Questionnaire [ Time Frame: Ten weeks ]

Central Contacts and Locations

Central contacts

Locations

GF Strong Rehabilitation Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 2G9

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-07-23.