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Assist-Knee: Energy-Harvesting Knee Prosthesis

NCT04023045 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-10-18

Study results available
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Summary

The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .

Conditions

  • Transfemoral Amputation
  • Artificial Limbs

Interventions

DEVICE

Assist-Knee

Assist-Knee is an experimental lower limb knee prosthesis.

DEVICE

Habitual Prosthesis

Habitual baseline prosthesis prescribed by participant's clinician.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Orthocare Innovations, LLC

    lead INDUSTRY

Principal Investigators

  • Sarah Chang, PhD · Orthocare Innovations, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2020-02-26
Completion
2020-02-26
FDA Device
Yes

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 NCT04023045 on ClinicalTrials.gov