Immersive Versus Non-immersive Virtual Reality in Enhancing Upper Limb Functions Among Individuals With Subacute Stage Hemiplegia - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment for upper extremity (FMA-UE)
研究概览
简要总结
The goal of this randomized controlled trial is to compare the effectiveness of immersive virtual reality combined with conventional therapy to the effectiveness of non-immersive virtual reality combined with conventional therapy in enhancing upper limb function in subacute hemiplegic stroke patients.
详细描述
The study is a single blinded randomized controlled trial in which the assessor will be blinded. Male and female participants aged between 28-55 years are included in the study. Participants are selected based on inclusion and exclusion criteria and are later randomly assigned to Group 1 and Group 2.
Group 1 - Conventional therapy and Immersive Virtual Reality Group 2 - Conventional therapy and Non-Immersive Virtual Reality
Primary Outcome measures include the Fugl Meyer Assessment for Upper limb and Graded Wolf Motor Function test for upper limb.
Secondary Outcome measure is the Stroke Specific Quality of Life Scale (SS-QOL) Questionnaire.
Therapy session starts with 15 minutes of stretching and strengthening exercises of the affected arm followed by 45 minutes of Immersive / Non Immersive virtual reality training.
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
- 28 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 28-55 years.
- •Diagnosed with hemiplegia due to stroke.
- •≤ Grade 2 on Modified Ashworth scale.
- •≤ Stage 2 on Brunnstrom stages of motor recovery.
- •Score of ≥ 35/36 on Cognitive assessment scale for stroke patients (CASP)
排除标准
- •Contraindications for VR therapy, such as severe motion sickness or photosensitive epilepsy, impaired spatial awareness.
- •Pre-existing neurological conditions such as spinal cord injury, Multiple sclerosis and so affecting upper limb function.
结局指标
主要结局
Fugl-Meyer Assessment for upper extremity (FMA-UE)
时间窗: From enrollment to the end treatment at 6 weeks
A valid, reliable, and comprehensive measurement tool with an intra-rater reliability of ICC 0.96 and interrater reliability of ICC 0.98, used to evaluate motor impairment, balance, sensation, and joint function in the upper extremities after stroke.
Graded Wolf Motor function test - The WMFT
时间窗: From enrollment to the end treatment at 6 weeks
This test is designed to assess motor function, strength, and coordination in individuals with upper extremity impairments. It is a reliable measure with inter-rater reliability of 0.97 and intra-rater reliability of 0.90.
次要结局
- Stroke Specific Quality of Life Scale (SS-QOL)(From enrollment to the end treatment at 6 weeks)
研究者
Athira George
Principal Investigator
Gulf Medical University