Testing of the Somatosensation Device (SD) for Device Effectiveness While Enhancing Feedback in Lower Extremities
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Functional Gait Assessment (FGA)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.
Investigators
Arun Jayaraman, PT, PhD
Principle Investigator
Shirley Ryan AbilityLab
Eligibility Criteria
Inclusion Criteria
- •Have a below-knee amputation (either unilateral or bilateral) or neuropathy in their lower limbs.
- •Ability to wear the somatosensation device on their lower limbs
- •Ability to wear test equipment and heart rate monitors.
- •Ability to follow simple directions.
Exclusion Criteria
- •History of severe back pain in the last 3 months.
- •History of severe knee pain in the last 3 months.
- •Unable to walk for 3 minutes with or without an assistive device
- •Poor skin integrity (i.e open wounds, skin breakdown) that could be made worse by wearing the somatosensation device.
Outcomes
Primary Outcomes
Functional Gait Assessment (FGA)
Time Frame: Baseline, during the intervention
The Functional Gait Assessment is a test to assess an individual's postural stability and ability to perform multiple motor tasks while walking. Tests include walking at different speeds, walking with head turns, turns, stepping over obstacles, walking tandem, walking with eyes closed, walking backwards, and stair navigation. Scores are on a 0-30 scale, with higher scores showing better balance and mobility.
Secondary Outcomes
- Activities Specific Balance Confidence Scale (ABC)(Baseline, during the intervention)
- Mini-BESTest(Baseline, during the intervention)
- Vestibular Disorders Activities of Daily Living Scale (VADL)(Baseline, during the intervention)
- 10 Meter Walk Test(Baseline, during the intervention)