Wearable Technology to Assess Gait Function in Spinal Muscle Atrophy and Duchenne Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Validation of Instrumented Insoles: Circle Walking
研究概览
简要总结
The purpose of this project is to devise instrumented insoles capable of accurately measuring gait at each footfall, over multiple hours in any environment. To achieve high accuracy, the investigators will develop a new learning-based calibration framework. Features will be tested in controlled lab settings 39 during a single visit in people with SMA (13), DMD (13) and healthy controls (13) and in 15 participants in real-life environments.
详细描述
Spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD) are genetic disorders that often result in progressive weakness and impaired function. Results from this study will help characterize how gait is affected in SMA and DMD. This novel device can serve as a more affordable and versatile measurement instrument for neuromuscular disorders that affect gait and balance. All participants will be observed and measured while wearing the instrumented insoles in the lab and in real-life environments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One of the following categories:
- •Genetic confirmation of spinal muscular atrophy
- •Genetic confirmation of Duchenne or Becker muscular dystrophy or evidence on muscle biopsy with a clinical presentation consistent with DMD/BMD
- •Healthy individuals.
- •Able to walk independently at least 25 meters
排除标准
- •Unable to walk 25 meters independently.
- •Use of investigational medications intended for the treatment of SMA or DMD/BMD within 30 days prior to study entry.
结局指标
主要结局
Validation of Instrumented Insoles: Circle Walking
时间窗: Baseline
To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway participants will be asked to walk a series of half-circles on the instrumented walkway.
Muscle Strength Testing with Hand-held Dynamometry (HHD)
时间窗: Baseline
HHD is used to assess strength of selected muscles.
Validation of Instrumented Insoles: Six Minute Walk Test
时间窗: Baseline
To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway participants will complete the Six Minute Walk Test. This test is an objective evaluation of functional exercise capacity, measures the maximum distance a person can walk in six minutes over a 25 meter course. This will be performed in a corridor and include the instrumented walkway.
Validation of Instrumented Insoles: 10 Meter Walk/Run
时间窗: Baseline
To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway, participants will walk, or run if able to, for 10 meters on the instrumented walkway.
Validation of Instrumented Insoles: Time Up and Go Test (TUG)
时间窗: Baseline
To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway, participants will complete the TUG test. This test is designed to test mobility after a person stands up from a seated position. This will be completed on the instrumented walkway.
Validation of Instrumented Insoles: Straight Line Walking
时间窗: Baseline
To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway, participants will be asked to walk in a straight line multiple times over the instrumented walkway.
次要结局
- Free-living Testing of Instrumented Insoles(One week)
研究者
Jacqueline Montes
Assistant Professor of Rehabilitation and Regenerative Medicine , Rehab & Regenerative Med PT
Columbia University