Analysis of Human Movement With Assistive Devices

Not Applicable

Recruiting

• Conditions: Limb Loss; Limb Weakness; Limb Paralysis; Movement Disorders
• Interventions: Device: Assist-Knee; Device: Prosthetic Knee; Device: Prosthetic Ankle; Device: Prosthetic Foot; Device: Ankle-Foot Orthosis

• Registration Number: NCT05729061
• Lead Sponsor: Orthocare Innovations, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-28
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-11-28
• Study Completion: 2024-11-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participant with intervention	Assist-Knee	Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.
Participant with intervention	Prosthetic Foot	Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.
Participant with intervention	Prosthetic Knee	Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.
Participant with intervention	Prosthetic Ankle	Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.
Participant with intervention	Ankle-Foot Orthosis	Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.

Primary Outcome Measures

Name	Time	Method
Walking Speed with intervention	Collection immediately after acclimation with intervention	Walking speed calculated over 8 meters of walking
Walking Speed with no intervention	Collection at baseline	Walking speed determined over 8 meters of walking

Secondary Outcome Measures

Name	Time	Method
Time to Complete Sit-to-Stand with no intervention	Collection at baseline	The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least three trials of the sit-to-stand maneuver are collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition are calculated for each participant. The start of the transition will be determined by participant initiation; the end of the transition will be determined by the participant reaching full knee extension.
Time to Complete Sit-to-Stand with intervention	Collection immediately after acclimation with intervention	The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least three trials of the sit-to-stand maneuver are collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition are calculated for each participant. The start of the transition will be determined by participant initiation; the end of the transition will be determined by the participant reaching full knee extension.
Timed Up and Go (TUG) Test	Collection at baseline	The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant will complete the TUG test for three trials. Time is measured using a stopwatch. Average and standard deviation of the time to complete the TUG test are calculated for each participant.
Timed Up and Go (TUG) Test with intervention	Collected immediately after acclimation with intervention	The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant will complete the TUG test for three trials. Time is measured using a stopwatch. Average and standard deviation of the time to complete the TUG test are calculated for each participant.

Trial Locations

Locations (1)

Orthocare Innovations, LLC; 🇺🇸 Edmonds, Washington, United States