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NCT03433300

Microprocessor Knees in Early Rehabilitation

Completed NA Last updated 11 September 2020
What this trial tests

NA trial testing Ottobock Kenevo/C-Leg in Amputation in 19 participants. Completed in 15 May 2020.

Timeline
13 April 2018
Primary endpoint
15 May 2020
15 May 2020

Quick facts

Lead sponsorUniversity of Washington
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment19
Start date13 April 2018
Primary completion15 May 2020
Estimated completion15 May 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Amputation

Currently open trials in the same condition.

Other University of Washington 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/NCT03433300.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing