Testing of the Somatosensation Device (SD) for Device Effectiveness While Enhancing Feedback in Lower Extremities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Functional Gait Assessment (FGA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Baseline (Without Somatosensation Device)
Participants will perform all outcome measures without wearing the somatosensation device.
干预措施: Baseline (Other)
With Somatosensation Device
Participants will perform all outcome measures while wearing the somatosensation device.
干预措施: Somatosensation Device (Device)
结局指标
主要结局
Functional Gait Assessment (FGA)
时间窗: 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.
次要结局
- 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)
研究者
Arun Jayaraman, PT, PhD
Principle Investigator
Shirley Ryan AbilityLab