Last reviewed · How we verify
NCT04120038: SMART
Self-Management for Amputee Rehabilitation Using Technology
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.
31 August 2021
Quick facts
| Lead sponsor | University of British Columbia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 12 |
| Start date | 26 January 2021 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Self-Management for Amputee Rehabilitation using Technology [SMART]
Conditions studied
- Unilateral Trans Tibial/Femoral Lower Limb Amputation — all drugs for Unilateral Trans Tibial/Femoral Lower Limb Amputation →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04120038
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04120038 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of British Columbia
- Last refreshed: 15 October 2021
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing