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临床试验/NCT03039764
NCT03039764撤回不适用

The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy

Montefiore Medical Center1 个研究点 分布在 1 个国家开始时间: 2018年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test

研究概览

简要总结

To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their hand in supplementation with conventional occupational therapy to assess whether it improves motor function and speed recovery during inpatient rehabilitation versus conventional occupational therapy alone. Also, what impact does this have on quality of life.

详细描述

The American Stroke Association states that stroke is 5th leading cause of death in the United States and one of the leading causes of disability and loss of motor function. Approximately 80% of stroke survivors have upper extremity limitations where the distal upper extremity motor function is severely affected and is the last body part to recover. Restoration of arm function is essential to regaining activities of daily living (ADL) such as holding objects like utensils, turning a doorknob, writing or telephone use. Literature search shows that intensive and repetitive training may be necessary to modify neural organization and recover functional motor skills. Along with traditional rehabilitation methods, virtual reality (VR) based rehabilitation has emerged in recent years. VR-based rehabilitation is more intensive, of longer duration and more repetitive. Using VR rehabilitation, repetitive dull exercises can turn into a more challenging and motivating tasks such as games. Moreover, VR-based rehabilitation can provide a quantitative measure of the rehabilitation progress.

The investigators propose a study comparing conventional occupational services versus virtual reality-based rehabilitation intervention for participants during acute phase of stroke in the inpatient rehabilitation setting. The investigators hypothesize that by using VRA, will see a significant increase in the overall motor function, shorter hospital course and improved quality of life for the participants.

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

  • •Minimum age of 18 years' old
  • •Unilateral upper extremity functional deficits after stroke
  • •First ever clinical diagnosis of stroke in the dominant hemisphere
  • •Diagnosis of ischemic or hemorrhagic stroke with unilateral paresis of dominant hand

排除标准

  • •Age less than 18 years' old
  • •Cognitive impairment resulting in inability to participate
  • •Severe aphasia resulting in inability to communicate to give consent or participate.

研究组 & 干预措施

Standard occupational therapy

No Intervention

This group will receiving standard occupational therapy for the treatment of acute stroke.

SOT plus VR Rapael

Experimental

This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.

干预措施: Rapael (Device)

结局指标

主要结局

Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test

时间窗: 3 Months

Scores on the Wolf Motor Function test measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.

次要结局

  • Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire(3 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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