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Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait

NCT06433648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-30

No results posted yet for this study

Summary

The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees.

Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle.

Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only.

Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle).

Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.

Conditions

  • Amputation
  • Amputation, Traumatic
  • Amputation of Knee
  • Amputation; Traumatic, Limb

Interventions

DEVICE

Ottobock CLeg4 + Ottobock foot

Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.

DEVICE

SRALAB Hybrid Knee + Polycentric Ankle

Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.

DEVICE

SRALAB Hybrid Knee + Passive Ankle

Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.

DEVICE

Ottobock CLeg 4 + Polycentric Ankle

Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.

Sponsors & Collaborators

  • Shirley Ryan AbilityLab

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2028-06-30
Completion
2029-06-30

Countries

  • United States

Study Locations

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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 NCT06433648 on ClinicalTrials.gov