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临床试验/NCT02364700
NCT02364700已完成不适用

Hand Training Utilizing an Electromyography-triggered Hand Robot for Individuals After Chronic Stroke

Rehab-Robotics Company Limited2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Box and Blocks

研究概览

简要总结

This is an interventional pilot study investigating the feasibility of using the hand of hope (HOH) device for individuals with decreased hand function after stroke.

详细描述

The HOH will be used to provide hand training for patients with decreased hand ability after stroke. The HOH is a light-weight, non-invasive, portable hand robot that provides physical assistance when a patient activates the muscles that open and close the hand. The HOH works by detecting surface EMG muscle activity and therefore requires active participation from the patient throughout the session. Video games linked to the HOH device are specifically designed to work on opening and closing the hand facilitating mass practice and high repetition needed for improving strength and range of motion of muscles.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of stroke > 6 months ago
  • Presence of some active range of motion (AROM) in the affected hand, measured by a score of at least 1 on the Box and Block test.
  • Intact sensation in the affected hand
  • Full passive range of motion (PROM) in mass flexion and extension of the hand
  • MAS score < 3 for finger flexors and intrinsics
  • MAS score < 3 for finger extensors
  • Visual tracking is intact in all directions
  • Patient must be otherwise medically stable in the opinion of the principal investigator

排除标准

  • Patient is receiving active occupational or physical therapy for the affected arm
  • Patient has joint contractures that prevent proper fit into the HOH device
  • Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis
  • It has been less than 3 months since last botulinum toxin injection in the affected arm

结局指标

主要结局

Box and Blocks

时间窗: Baseline to 6 weeks (discharge)

The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.

Fugl-Meyer Assessment of Upper Extremity (FMA)

时间窗: baseline to 6 weeks (discharge)

The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.

Arm Motor Ability Test (AMAT)

时间窗: Baseline to 6 weeks (discharge)

The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.

次要结局

  • Stroke Impact Scale --Hand Sub Scale (SIS-H)(baseline to 6 weeks (discharge))
  • Stroke Upper Limb Capacity Scale (SULCS)(Baseline to 6 weeks (discharge))
  • Hand Dynamometry(baseline to 6 weeks (discharge))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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