Analysis of Human Movement With Assistive Devices

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of Human Movement With Assistive Devices

Conditions
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Limb Loss, Limb Weakness, Limb Paralysis, Movement Disorders

Intervention / Treatment
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* Device: Assist-Knee
* Device: Prosthetic Knee
* Device: Prosthetic Ankle
* Device: Prosthetic Foot
* Device: Ankle-Foot Orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Participant with normal assistive device<br>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<br>Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study. | Device: Assist-Knee<br>* Investigational prosthetic knee-ankle device<br>Device: Prosthetic Knee<br>* Commercially available prosthetic knee devices<br>Device: Prosthetic Ankle<br>* Commercially available prosthetic ankle devices<br>Device: Prosthetic Foot<br>* Commercially available prosthetic foot devices<br>Device: Ankle-Foot Orthosis<br>* Commercially available ankle-foot orthosis devices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Speed with no intervention | Walking speed determined over 8 meters of walking | Collection at baseline | 
| Walking Speed with intervention | Walking speed calculated over 8 meters of walking | Collection immediately after acclimation with intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |