Limb Loss, Limb Paralysis, Limb Weakness, Movement Disorders
Conditions
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.
Interventions
DEVICEAssist-Knee
Investigational prosthetic knee-ankle device
DEVICEProsthetic Knee
Commercially available prosthetic knee devices
DEVICEProsthetic Ankle
Commercially available prosthetic ankle devices
DEVICEProsthetic Foot
Commercially available prosthetic foot devices
DEVICEAnkle-Foot Orthosis
Commercially available ankle-foot orthosis devices
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Orthocare Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactAdam Arabian, PhD
Outcome results
None listed