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NCT04120038: SMART

Self-Management for Amputee Rehabilitation Using Technology

Completed NA Last updated 15 October 2021
What this trial tests

NA trial testing Self-Management for Amputee Rehabilitation using Technology [SMART] in Unilateral Trans Tibial/Femoral Lower Limb Amputation in 12 participants. Completed in 31 August 2021.

Timeline
26 January 2021
Primary endpoint
31 August 2021
31 August 2021

Quick facts

Lead sponsorUniversity of British Columbia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment12
Start date26 January 2021
Primary completion31 August 2021
Estimated completion31 August 2021
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

Adults 19 to 100, any sex, with Unilateral Trans Tibial/Femoral Lower Limb Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes.
    B Aledi L, Flumignan CD, Trevisani VF, Miranda F. · · 2023 · cited 5× · PMID 37276273 · DOI 10.1002/14651858.cd013711.pub2

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Other University of British Columbia trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04120038.

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