Self-Management for Amputee Rehabilitation Using Technology.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of British Columbia

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • SMART

    Behavioral

    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

    Behavioral

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

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: SMARTExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

TUG, Timed Up and Go test

The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.

Time frame
Ten weeks
2

ASCQ, the Ambulatory Self-Confidence Questionnaire

This questionnaire measures how confident you are in your ability to walk. Type of Administration: Self-Report. Response Scale: 0 (not confident at all) - 10 (extremely confident) Scoring: Participants' total score is derived by calculating a mean score Interpretation: Higher scores = higher level of self-confidence regarding ambulation

Time frame
Ten weeks

Secondary outcomes

1

Self-Report Habit Index (SRHI)

12-item questionnaire based on the 7-point Likert scale with the range of total score between 0 to 84, which higher scores show the stronger habit strength

Time frame
Ten weeks
2

Physical Activity Identity (PAI)

Physical activity self-identification 7 point likert scale. Higher score = higher physical activity identification PAI items relate to how much the participant identifies with being physically active.

Time frame
Ten weeks
3

The Revised Amputee Body Image Scale (ABIS-R)

This questionnaire is designed to measure how you see and feel about your body image. It is not a test so there are no right or wrong answers. Please answer each item as carefully and as accurately as you can by placing the appropriate number beside each question as follows. Scale of 0, 1, 2. 0 = none of the time, 2 = most of the time High scores indicate high body image disturbance.

Time frame
Ten weeks
4

Center for Epidemiologic Studies Depression Scale (CES-D)

Below is a list of the ways you might have felt or behaved. Please tell me how often you have felt this way during the past week. 20 items Scoring: 0, 1, 2, 3 representing "rarely" to "most of the time", respectively. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

Time frame
Ten weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator