Self-Management for Amputee Rehabilitation Using Technology

NCT04120038 | Completed

• 1 other identifier: H19-02241
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the walking capacity and confidence of individuals with unilateral lower limb amputation (LLA). Our primary hypothesis is that SMART can improve walking capacity in individuals with LLA. Our secondary hypothesis is that SMART can improve ambulation confidence, body function, depression, body image, pain, balance confidence, activities of daily living, satisfaction with life and habit formation for skin monitoring and prosthetic cleaning in individuals with LLA. A post-intervention one on one interview will be conducted to understand SMART acceptability. The entirety of the study, including intervention administration, assessment, and interviews will be conducted online.

Conditions

Unilateral Trans Tibial/Femoral Lower Limb Amputation

Keywords

Occupational Therapy; Rehabilitation; Lower-Limb Amputations; Amputees; Telehealth; Remote Rehabilitation; Telerehabilitation; E-learning; Education; Self-Management; Ambulation; Coping Strategies; Outcomes; Prevalence

Outcome Measures

Primary Outcomes (1)

• Timed Up & Go Test (TUG)

  Functional assessment of walking capacity measured in seconds over 3 meters walkway

  6 weeks

Secondary Outcomes (2)

• Ambulatory Self-Confidence Questionnaire (ASCQ)

  6 weeks

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

  6 weeks

Other Outcomes (10)

• Revised Amputee Body Image Scale (ABIS-R)

  6 weeks

• Pain Questionnaire

  6 weeks

• Activities Specific Balance Confidence Scale (ABC).

  6 weeks

Study Arms (1)

SMART & Peer Support

EXPERIMENTAL

Device: Self-Management for Amputee Rehabilitation using Technology [SMART]

Interventions

Self-Management for Amputee Rehabilitation using Technology [SMART] DEVICE

Participants will complete a 6-week tablet-based education program for individuals with LLA that will provide them with self-management education.

SMART & Peer Support

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults who are 19 years of age or older.
• individuals who are post unilateral transtibial/transfemoral amputation and casted an initial prosthesis within the past year.
• English speaking.
• living in British Columbia or Ontario, Canada.
• have access to an internet connectable device (e.g., computer or tablet)

You may not qualify if:

• \) people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator
• GF Strong Rehabilitation Centre: collaborator

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z2G9, Canada

Location

Related Publications (1)

• B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

  PMID: 37276273 DERIVED

Study Officials

• William C Miller, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: January 26, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

CA (1)