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

NCT ID: NCT03632252

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-09-15

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.

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.

Conditions

Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Powered ankle prosthesis

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Deanna H Gates

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deanna H Gates, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

C D Remy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

R03HD092639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00139671

Identifier Type: -

Identifier Source: org_study_id