Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Sustained grip strength
研究概览
简要总结
The primary objective of this study is to evaluate pinch strength improvements and improvements in coordination and functional ability. Pinch strength measurements are made on subjects both with and without the device to evaluate the potential improvements. Also, coordination and functional testing is performed both with and without the device to compare performance under both conditions and evaluate potential improvement.
详细描述
This study tests the powered hand orthosis device on a small number of participants (up to 6). Research participants with neuromusculoskeletal impairments were recruited for the study and consented with an approved protocol. The study was conducted during 1 visit to LTI in Holliston, MA . The study consists of several assessments. Participants are surveyed for cognitive limitations and self-assessment of difficulties in completing tasks of daily living by completing surveys such as the Quickdash Questionnaire [1], the Mini-Mental State test [2], and the McGann Feedback form [3]. Pinch strength without and with the powered orthosis is evaluated. A selection of functional outcome measures are performed such as the Southampton Hand Assessment Procedure (SHAP) [4], the Nine-Hole Peg Test (NHP) [5], and the Box and Blocks Test (BBT) [6].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Participants in this study must meet the following inclusion/
排除标准
- •Subjects diagnosed with one of these conditions- ALS, brachial plexus injuries, CVA hemiplegia, multiple sclerosis, muscular dystrophy, spinal cord injury, and traumatic brain injury
- •Range of motion (ROM) and strength characterized by one of the following limitations:
- •Range of motion within functional limits (as determined by our OT consultant Deb Latour), but with limited pinch strength measured by a pinch meter of less than 2 pounds or manual muscle test grade of
- •Limited range of motion of the wrist, thumb, index, and middle fingers as determined by a clinical occupational therapist
- •Passive ROM within functional limits as determined by our OT consultant Deb Latour
- •No tremors in the hand or arm
- •Must be able to understand and follow up to 3 step directions for testing
- •No other comorbidities that may affect their ability to use the device
- •Modified Ashworth Scale assessment for spasticity of less than 2
- •Greater than 18 years old
- •Must be able to wear a powered hand orthosis device.
- •Be able to make the required visit(s) to LTI for testing
- •Mini-mental test [2] score greater than 18
研究组 & 干预措施
Experimental Power Hand Orthosis
Participants will test the improved grip strength using the powered hand orthosis system.
干预措施: Powered Hand Orthosis (Device)
Experimental Power Hand Orthosis - Tasks of Daily Living
Participants will test the improved ability to perform tasks of daily living using the powered hand orthosis system.
干预措施: Powered Hand Orthosis (Device)
结局指标
主要结局
Sustained grip strength
时间窗: 1 minute
The sustained grip available for achieving activities of daily living that require a sustained grip
次要结局
- Maximum Grip Strength(10 seconds)
- Accomplishing activities of daily living(10 minutes)