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Self-Management for Amputee Rehabilitation Using Technology

NCT ID: NCT04120038

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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Participants will receive an online link to access the SMART platform. Online training on using the SMART platform will be provided for participants. Participants will be asked to complete one education module per week at their own convenience and weekly online meetings with a peer over the 6-week intervention period. The educational modules include psychological adaptation, residual limb management, nutrition/weight control, managing a prosthetic limb, managing chronic conditions and enhancing mobility. The modules include instructional movies, goal setting logs, and quizzes. A module can be stopped or "re-wound" at any point, and the participant's place and work-to-date is automatically saved. The SMART platform will be asynchronously monitored through a web portal by the trainer, who will be a PhD candidate in Rehabilitation Sciences and observe participant progress and provide feedback if required. If there is no online activity within a 7-day (consecutive) period, the trainer will contact the participant to inquire the reasons for inactivity and troubleshoot any problems including technical issues. Clinical outcomes measures will be collected at two timepoints (T1 \& T2). A post-intervention one on one interview will be conducted to explore SMART acceptability.

Conditions

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Unilateral Trans Tibial/Femoral Lower Limb Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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SMART & Peer Support

Group Type EXPERIMENTAL

Self-Management for Amputee Rehabilitation using Technology [SMART]

Intervention Type DEVICE

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

Interventions

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Self-Management for Amputee Rehabilitation using Technology [SMART]

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vancouver Coastal Health Research Institute

OTHER

Sponsor Role collaborator

GF Strong Rehabilitation Centre

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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William C. Miller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William C Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 37276273 (View on PubMed)

Other Identifiers

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H19-02241

Identifier Type: -

Identifier Source: org_study_id