NCT05729061

Analysis of Human Movement With Assistive Devices

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Orthocare Innovations, LLC · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization. Because this research focuses on evaluating how different people move about in different settings with different assistive devices/components, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.

Conditions

• Limb Loss
• Limb Weakness
• Limb Paralysis
• Movement Disorders

Interventions

Type	Name	Description
DEVICE	Assist-Knee	Investigational prosthetic knee-ankle device
DEVICE	Prosthetic Knee	Commercially available prosthetic knee devices
DEVICE	Prosthetic Ankle	Commercially available prosthetic ankle devices
DEVICE	Prosthetic Foot	Commercially available prosthetic foot devices
DEVICE	Ankle-Foot Orthosis	Commercially available ankle-foot orthosis devices

Timeline

• Start date: 2022-11-28
• Primary completion: 2024-11-28
• Completion: 2024-11-28
• First posted: 2023-02-15
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study