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Evaluation of Transfemoral Amputees When Transitioning From a Mechanical to a Microprocessor Prosthetic Knee

NCT03829202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-10-08

No results posted yet for this study

Summary

The central hypothesis of this proposal is that real-life benefits of microprocessor knees (MPK) are largely underappreciated because of the lack of sensitive and ecologically valid methods for evaluating motor performance. This makes it difficult to justify MPKs for many amputees who could benefit from it. Using recently developed outcome measures shown to be more effective in evaluating prosthesis users than commonly employed metrics, 7 transfemoral prosthesis users who exclusivity utilize a non-microprocessor mechanical knee were evaluated as they transitioned to and from an MPK in an ABA/BAB single subject design protocol. Subjects were also evaluated with existing clinical measures established for lower limb amputees.

Conditions

  • Amputation of Lower Limb Above Knee

Interventions

DEVICE

Own mechanical knee

Daily use of own mechanical knee

DEVICE

RheoKnee microprocessor prosthetic knee

Daily use of RheoKnee microprocessor prosthetic knee

Sponsors & Collaborators

  • Össur Iceland ehf

    collaborator INDUSTRY

  • Methodist Rehabilitation Center

    lead OTHER

Principal Investigators

  • Dobrivoje Stokic, MD, DSc · Methodist Rehabilitation Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-19
Primary Completion
2014-08-12
Completion
2014-08-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829202 on ClinicalTrials.gov