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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05729061
Other study ID # AD-001
Secondary ID R44HD097826
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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