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临床试验/NCT06582303
NCT06582303已完成不适用

Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation

National University of Science and Technology, Pakistan2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

研究概览

简要总结

The study was a randomized control trial conducted to determine whether VR games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. An investigation has been conducted to assess the efficacy of virtual reality games that enhance hand motor functions to attain long-lasting improvements. Patients were randomly assigned to the experimental and control groups. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week, for a total duration of 6 weeks. Developed four VR-based hand games that include hitting a rolling ball, grasping a balloon, swapping hands, and gripping a pencil.

详细描述

The field of stroke rehabilitation frequently faces limitations in therapies and struggles to achieve long-lasting improvements in hand motor function. The integration of fully immersive virtual reality (VR) games with visual training feedback significantly improves the efficacy of stroke rehabilitation. Virtual reality (VR) games that incorporate repetitive and particular tasks stimulate the gradual activation of brain pathways linked to motor activities. VR research has the potential to enhance VR intervention games by combining cognitive engagement with visual feedback.

The objective of this study was to develop and evaluate virtual reality games that utilize an approach of cognitive engagement within visual feedback in order to enhance hand-motor capabilities. The study utilized completely immersive virtual reality (VR) games specifically designed for subacute stroke patients. The implementation of fully immersive virtual reality (VR) games as an intervention proved to be highly effective in significantly maintaining the motor recovery of patients who had experienced a stroke in the subacute phase. Stroke patients exhibited enhanced dexterity, heightened range of motion, greater hand strength, and improved grip.

Developed VR games utilize a virtual reality device and are designed to be controlled by hand movements such as flexion/extension, close/open, supination/pronation, and pinch. Patients were randomly assigned to the experimental and control groups. The experimental group received a VR hand game intervention with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks.

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
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

  • Montreal Cognitive Assessment (MOCA ≥ 21)
  • Modified Ashworth Scale (MAS< 4)
  • Fugl-Meyer Assessment (FMA between 25 and 55)
  • Age ≥ 18 years
  • Stroke patient type (Subacute patients)

排除标准

  • Wrist Impairments
  • Contractures
  • Patients with vestibular issues
  • Permanent external fixation

结局指标

主要结局

Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

时间窗: Baseline, 4th week, 6th week, and 9th week (follow-up)

The Fugl-Meyer Assessment-Upper Extremity subscale was employed to examine the motor function restoration in the upper extremity of stroke patients following interventions. The Fugl-Meyer Assessment-Upper Extremity consists of 33 items that assess motor function, with a scoring range of 0-66, The minimum score 0 represents severe impairment, and maximum score 66 represents normal motor function. Higher scores indicate better motor function.

Action Research Arm Test (ARAT)

时间窗: Baseline, 4th week, 6th week, and 9th week (follow-up)

The Action Research Arm Test is utilized to examine the functional capabilities of stroke patients upper extremities, specifically in terms of reaching, gripping, pinching, and overall movement tasks. Each item is allocated a rating score of 4 points, with the potential total values ranging from 0 to 57. The minimum score 0 represents severe impairment, and the maximum score 57 represents normal upper extremity function. Higher scores on the Action Research Arm Test indicate better functional capabilities of the upper extremities.

Box and Block Test (BBT)

时间窗: Baseline, 4th week, 6th week, and 9th week (follow-up)

The BBT evaluated the manual dexterity of individuals who had suffered a stroke. During this assessment, participants are required to transfer blocks from one container to another within a one-minute time limit.

Correlation between electromyography signal features and clinical outcomes

时间窗: Baseline, 4th week, 6th week, and 9th week (follow-up)

Electromyography signals are obtained in order to evaluate the electrical activity generated by muscles. Electromyography was utilized for the objective assessment of the effectiveness of immersive VR-based hand games. The objective assessment includes the evaluation of the correlation between electromyography signal features and clinical outcomes, which includes the Fugl-Meyer Assessment-Upper Extremity, Action Research Arm Test, and Box and Block Test.

Movement performance

时间窗: Baseline, 4th week, 6th week, and 9th week (follow-up)

The weekly movement performance was evaluated by machine learning algorithms that include k-nearest neighbors, random forest, and support vector machine classifiers on the electromyography signals of stroke patients.

次要结局

  • Modified Barthel Index (MBI)(Baseline and 9th week (follow-up))
  • Stroke-Specific Quality of Life (SSQOL)(Baseline and 9th week (follow-up))

研究者

发起方
National University of Science and Technology, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Asim Waris

Dr

National University of Science and Technology, Pakistan

研究点 (2)

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