NCT03632252

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

2.3 years

First QC Date

August 13, 2018

Last Update Submit

January 13, 2022

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

  • Minimum metabolic cost

    The minimum oxygen consumption rate required for walking

    3 minutes

Study Arms (1)

Powered ankle prosthesis

EXPERIMENTAL

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

Interventions

Powered ankle prosthesisDEVICE

This device is a custom designed ankle prosthesis. Motors control force on the device through cables but are not worn by the person.

Powered ankle prosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Deanna H Gates, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • C D Remy, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

May 1, 2019

Primary Completion

September 1, 2021

Study Completion

September 15, 2021

Last Updated

January 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)