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

Not Applicable

Withdrawn

• Conditions: Amputation
• Interventions: Device: Powered ankle prosthesis

• Registration Number: NCT03632252
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2019-05-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Powered ankle prosthesis	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.

Primary Outcome Measures

Name	Time	Method
Minimum metabolic cost	3 minutes	The minimum oxygen consumption rate required for walking

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States