Self-Management for Amputee Rehabilitation Using Technology.

NCT04953364 | Recruiting DMC

• 1 other identifier: H20-03316
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Ten weeks

• 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

  Ten weeks

Secondary Outcomes (12)

• Self-Report Habit Index (SRHI)

  Ten weeks

• Physical Activity Identity (PAI)

  Ten weeks

• The Revised Amputee Body Image Scale (ABIS-R)

  Ten weeks

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Ten weeks

• Self-Report Habit Index (SRH)

  Ten weeks

Study Arms (2)

SMART

EXPERIMENTAL

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.

Behavioral: SMART

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

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.

SMART

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

Related Publications (1)

• Esfandiari E, Miller WC, King S, Payne M, Mortenson WB, Underwood H, MacKay C, Ashe MC. 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. PLoS One. 2023 Mar 23;18(3):e0278418. doi: 10.1371/journal.pone.0278418. eCollection 2023.

  PMID: 36952517 DERIVED

MeSH Terms

Conditions

Behavior; Wounds and Injuries

Study Officials

• William C Miller, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William C Miller, PhD

CONTACT

+1 (604) 312-5245; bill.miller@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial (RCT)

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: July 8, 2021
• Study Start: October 14, 2022
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CA (1)