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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03632252
• Other study ID #: HUM00139671
• Secondary ID: R03HD092639
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: January 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 15, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum metabolic cost	The minimum oxygen consumption rate required for walking	3 minutes