Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
Healthy Volunteers
ID04953364

Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation

Led by University of British Columbia · Updated on 2024-07-23

82

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Lower Limb Amputations (LLAs) pose significant challenges for patients, impacting mobility, mental health, and social life, especially in adults aged 50 and over. This research evaluates the Self-Management for Amputee Rehabilitation using Technology (SMART) program, an online platform designed to support people with unilateral above or below knee amputation. The study aims to assess how SMART influences patients' confidence in walking and their ability to manage daily activities compared to traditional paper-based education. Participants are randomly assigned to two groups: one receives the SMART program via a tablet for six weeks, which includes mental and physical wellness education, prosthetic limb management, and weekly peer support through calls or video chats. The other group receives a care booklet and weekly contact for six weeks. Both groups continue their usual care during the study. The program also allows participants to communicate asynchronously with trainers through a secure website. During the study, participants will be monitored remotely via Zoom for confidence in walking using the Ambulatory Self-Confidence Questionnaire and walking ability using the Timed Up and Go test at ten weeks. Additional assessments include mood, body image, pain, physical function, and quality of life. Researchers will also explore participants' experiences through interviews. The study tracks the program's reach, effectiveness, adoption, and long-term maintenance, with all data collection and support conducted online. The total study period includes a six-week intervention and a four-week follow-up.

CONDITIONS

Brief Title

Self-Management for Amputee Rehabilitation Using Technology.

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Has a unilateral lower limb amputation (transtibial or transfemoral) due to diabetes or vascular disease
  • Received initial casting of their prosthesis within the past 2 years
  • Aged 50 years or older
  • Can speak and read English
  • Has access to a computer or tablet and internet
  • Lives in British Columbia or Ontario, Canada
Not Eligible

You will not qualify if you...

  • Has substantial health conditions such as congestive heart failure or diagnosed dementia
  • Anticipates further surgery like lower limb amputation revision
  • Unable to use a tablet, for example, difficulty typing with hands

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (remote via Zoom)

Outpatient Treatment

Duration - 6 weeks

Participants receive either the SMART self-management program using a tablet with weekly peer-support calls or a care booklet with weekly contacts, both lasting 6 weeks. This includes mental and physical wellness support, prosthetic limb management, and motivation through goal setting.

Weekly remote visits via Zoom

Follow-up

Duration - 4 weeks

Participants are monitored for retention effects and outcomes such as confidence in ambulation and walking capacity after completing the 6-week intervention.

Remote follow-up visits via Zoom

Trial Site Locations

Total: 1 location

1

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada, V5Z 2G9

Actively Recruiting

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Research Team

W

William C Miller, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Protocol for a randomized controlled trial to assess the effect of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for individuals with lower limb loss.

Elham Esfandiari, W C Miller, Sheena King...

https://pubmed.ncbi.nlm.nih.gov/36952517