Analysis of Human Movement With Assistive Devices
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Participant with normal assistive device Normal assistive device refers to the habitual assistive device that may be prescribed by a provider of care or no assistive device if the individual does not normally use. |
|
| Other: Participant with intervention Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study. |
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
|
Outcome Measures
Primary Outcome Measures
- Walking Speed with no intervention [Collection at baseline]
Walking speed determined over 8 meters of walking
- Walking Speed with intervention [Collection immediately after acclimation with intervention]
Walking speed calculated over 8 meters of walking
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria for Nondisabled Participants:
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Age 18 - 90 years
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Has bilateral normal range of motion
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Able to perform a variety of movement activities
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Able to communicate and write individual perceptions in English
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Able to provide written informed consent
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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:
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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
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Pregnancy
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Not able to read and understand English
Inclusion Criteria for Participants with a Disability:
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Age 18 - 90 years
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Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders
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Medically stable
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Has stable balance
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Able to perform a variety of movement activities
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Able to communicate and write individual perceptions in English
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Able to provide written informed consent
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Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
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Able to safely complete the movements being tested and/or safely use the assistive devices being tested
Exclusion Criteria for Participants with a Disability:
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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
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Pregnancy
-
Not able to read and understand English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orthocare Innovations, LLC | Edmonds | Washington | United States | 98020 |
Sponsors and Collaborators
- Orthocare Innovations, LLC
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Sarah Chang, PhD, Orthocare Innovations, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AD-001
- R44HD097826