Analysis of Human Movement With Assistive Devices

Movement Disorders Clinical Trial

Official title:

Analysis of Human Movement With Assistive Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729061
• Other study ID #: AD-001
• Secondary ID: R44HD097826
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: November 28, 2024

Study information

• Verified date: October 2023
• Source: Orthocare Innovations, LLC
• Contact: Adam Arabian, PhD
• Phone: 425-771-0797
• Email: arabian[@]orthocareinnovations.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 28, 2024
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria for Nondisabled Participants:

• Age 18 - 90 years
• Has bilateral normal range of motion
• Able to perform a variety of movement activities
• Able to communicate and write individual perceptions in English
• Able to provide written informed consent
• Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill

Exclusion Criteria for Nondisabled Participants:

• Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may not represent a nondisabled condition
• Pregnancy
• Not able to read and understand English

Inclusion Criteria for Participants with a Disability:

• Age 18 - 90 years
• Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders
• Medically stable
• Has stable balance
• Able to perform a variety of movement activities
• Able to communicate and write individual perceptions in English
• Able to provide written informed consent
• Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
• Able to safely complete the movements being tested and/or safely use the assistive devices being tested

Exclusion Criteria for Participants with a Disability:

• Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may result in mixed effects of multiple sources of disability
• Pregnancy
• Not able to read and understand English

Related Conditions & MeSH terms

• Limb Loss
• Movement Disorders
• Paralysis

Intervention

Device:
• Assist-Knee
Investigational prosthetic knee-ankle device
• Prosthetic Knee
Commercially available prosthetic knee devices
• Prosthetic Ankle
Commercially available prosthetic ankle devices
• Prosthetic Foot
Commercially available prosthetic foot devices
• Ankle-Foot Orthosis
Commercially available ankle-foot orthosis devices

Locations

Country	Name	City	State
United States	Orthocare Innovations, LLC	Edmonds	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Orthocare Innovations, LLC	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	Walking Speed with no intervention	Walking speed determined over 8 meters of walking	Collection at baseline
Primary	Walking Speed with intervention	Walking speed calculated over 8 meters of walking	Collection immediately after acclimation with intervention
Secondary	Time to Complete Sit-to-Stand with no 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.	Collection at baseline
Secondary	Time to Complete Sit-to-Stand 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.	Collection immediately after acclimation with intervention
Secondary	Timed Up and Go (TUG) Test	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.	Collection at baseline
Secondary	Timed Up and Go (TUG) Test 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.	Collected immediately after acclimation with intervention