Evaluating and Improving Assistive Robotic Devices Continuously and in Real-time

January 13, 2022 updated by: Deanna H Gates, University of Michigan
The goal of this research is to determine a quick, accurate and unobtrusive way to optimize the performance of powered assistive devices like ankle exoskeleton or prostheses.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Lower limb assistive robotic devices, such as active prosthesis, orthoses, and exoskeletons have the potential to restore function for the millions of Americans who experience mobility challenges due to injury and disability. Since individuals with mobility challenges have an increased metabolic costs of transport, the benefit of such assistive devices is commonly assessed via the reduction in the metabolic work rate of the individual who is using the device. Currently, metabolic work rate can only be obtained in a laboratory environment, using breath-by-breath measurements of respiratory gas analysis. To obtain a single steady state data point of metabolic work rate, multiple minutes of data must be collected, since the signals are noisy and slow. In addition, the user has to wear a mask and bulky equipment. The investigators propose an improved way to obtain such estimates of metabolic work rate in real-time. In this project, the investigators will use various small sensors to optimize push-off timing for an active ankle prosthesis.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has a unilateral amputation
  • Has used a prosthesis for at least 6 months

Exclusion Criteria:

  • History of orthopedic or neurologic disorders to their intact limb
  • History of cardiovascular disease
  • Unable to walk for 30 minutes at a time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Powered ankle prosthesis
We will use data from various sensors to optimize the amount of power provided by custom ankle ankle prosthesis. This is a single session study lasting about 4 hours.
Device: Powered ankle prosthesis
This device is a custom designed ankle prosthesis. Motors control force on the device through cables but are not worn by the person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum metabolic cost
Time Frame: 3 minutes
The minimum oxygen consumption rate required for walking
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

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

Investigators

  • Principal Investigator: Deanna H Gates, PhD, University of Michigan
  • Principal Investigator: C D Remy, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HUM00139671
  • R03HD092639 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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