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NCT03433300
Microprocessor Knees in Early Rehabilitation
NA trial testing Ottobock Kenevo/C-Leg in Amputation in 19 participants. Completed in 15 May 2020.
15 May 2020
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 13 April 2018 |
| Primary completion | 15 May 2020 |
| Estimated completion | 15 May 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ottobock Kenevo/C-Leg
- Ottobock 3R60/3R62
Conditions studied
- Amputation — all drugs for Amputation →
Sponsor
University of Washington
Who can join
18 and older, any sex, with Amputation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury. The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation.
Barr S, Howe TE. · · 2018 · cited 8× · PMID 30350430 · DOI 10.1002/14651858.cd005260.pub4 -
The effects of microprocessor prosthetic knee use in early rehabilitation: A pilot randomized controlled trial.
Morgan SJ, Friedly JL, Nelson IK, Rosen RE, et al · · 2025 · cited 2× · PMID 39895150 · DOI 10.1002/pmrj.13321
Verify or expand the search:
- PubMed search for NCT03433300
- 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 NCT03433300 (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 Washington
- Last refreshed: 11 September 2020
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/NCT03433300.
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