The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke: a Pilot Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change in Box and Blocks Test
研究概览
简要总结
Stroke often results in impairments of upper extremity, including coordination deficits, reducing of force, weakness and changes in the kinetic and kinematic workspace of fingers with 75% of stroke survivors facing difficulties performing activities of daily living.
The ability to oppose the fingertip of the thumb to each fingertip of the same hand is the basis of grasping objects of various sizes and operating tools and assessing and improving distal upper extremity function is of primary goal in the rehabilitation of stroke survivors. Moreover, repetitive movement practice seems to be crucial for maximizing therapeutic benefits.
Recent studies, proposed an engineered glove to assess motor performance during finger-to-thumb opposition movements and to provide objective and reproducible measures.
The same tool can be integrated with Virtual Reality and serious games to provide repetitive practice of activities improving motivation and adherence with therapy.
the investigators developed a new integrated glove and virtual reality to facilitate the recovery of hand functionality.
The aim of this study is to investigate the feasibility of the engineered glove in the assessment and treatment of hand dysfunction in people with Stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a single stroke,
- •some movement of the fingers,
- •any technical and difficulties with wearing the glove on the paretic hand
排除标准
- •visual or cognitive deficits that would prevent them for performing the task
研究组 & 干预措施
experimental group
Each subject will perform a variety of VR exercises to reduce impairments in their finger range of motion, speed and strength.
It includes a glove-shaped sensor device and a software application.
干预措施: experimental group (Other)
control group
Each subject will perform usual care rehabilitation aimed at improving manual dexterity
干预措施: control group (Other)
结局指标
主要结局
Change in Box and Blocks Test
时间窗: baseline- immediately after the intervention
Block and Box Test assesses grasp and transport and upper limb functional disorders and measures unilateral gross manual dexterity.
次要结局
- Change in the instrumented indexes(baseline- immediately after the intervention)
- Change in 9-Hole Peg Test(baseline- immediately after the intervention)
- Change in Manual Ability Measurement(baseline- immediately after the intervention)
研究者
Davide Cattaneo
Principal Investigator
Fondazione Don Carlo Gnocchi Onlus