Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy on Balance, Motor Function and Activities of Daily Living in Post Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Barthel Index
研究概览
简要总结
Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. In stroke patients, VR and MI combination has not been studied. This study aims to investigate the combined effects of Virtual Reality and Motor Imagery Techniques with Routine Physical Therapy in patients with post stroke patients.
详细描述
This randomized control trial will be conducted at Safi Hospital Faisalabad in 7 months after the approval of synopsis, involving a sample size of 75 participants selected through convenience sampling based on the inclusion criteria. Participants will be randomly assigned to three groups using lottery method, in which Group A, will receive Virtual Reality and Motor Imagery training in conjunction with routine physical therapy three days a week for 12 weeks. Group B will receive VR and routine physical therapy, supplemented by 10-15 minutes of cycling and walking and Group C will receive routine physical therapy with MI techniques, along with 10-15 minutes of cycling and walking.
Fugal-Meyer Scale will be used to motor function, Berg Balance Scale for balance and Barthel Index will be used to assess activities of daily living. Assessment will be carried out at baseline, 6th week, 8th week and at 12th week and at 16th week after the discontinuation of treatment. The data will be entered and analyzed by using SPSS 26
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)
盲法说明
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of stroke of any etiology
- •Age between 40 to 65 years
- •Both genders
- •At least 6 months post-stroke onset
- •Able to follow and understand visual and verbal commands.
- •Hemiparetic
- •No prior experience with VR-based rehabilitation.
- •Able to walk with the use of walking aids or assistive devices.
- •Mini-Mental State Examination (MMSE) score equal to or greater than 24
排除标准
- •Presence of aphasia, apraxia, and hemineglect
- •Serious cardiovascular disease (heart failure, arrhythmias, angina pectoris or myocardial infarction)
- •Cerebellar lesion
- •Multiple brain accidents
- •Muscular disorder effect upper and lower extremities
- •History of seizures or epilepsy.
- •Patients whose injury occurred fewer than 6 months previously, considering the expected time for spontaneous recovery;
- •Patients with associated disorders such as epilepsy, and sensory and perceptual deficits such as hemineglect and Pusher syndrome;
- •Patients with osteo degenerative disorders that would prevent participation in the games or that could influence the body balance; and individuals who had cognitive and communication disorders, affecting understanding, that could compromise performance in the games
- •Inability to commit to the study schedule or attend the required therapy sessions
研究组 & 干预措施
Group A: (Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy)
Participants in this group will receive Virtual Reality (VR) for and Motor Imagery (MI) training with routine physical therapy for every alternate day (3 days per week) for 12 weeks. Total 45 minutes of session.
Routine physical therapy protocol will be given for 30 minutes. VR techniques for 10-15 minutes MI techniques for 05-10 minutes
干预措施: Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy (Other)
Group B: (Virtual Reality + Routine Physical Therapy )
The VR system consisted of a wall-mounted display, a Nintendo Wii box, a Wii remote, and a Wii Fit board. The participants will be instructed to stand on Wii Fit board while interacting with the VR system and playing the selected games.
Routine physical therapy protocol will be given for 30 minutes along with cycling and walking for 10-15 minutes.
VR techniques for 10-15 minutes.
干预措施: Virtual Reality + Routine Physical Therapy (Other)
Group C: (Motor Imagery +Routine Physical Therapy)
During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video.
Routine physical therapy protocol will be given for 30 minutes along with Cycling and walking for 10-15 minutes MI techniques for 10-15 minutes
干预措施: Motor Imagery +Routine Physical Therapy (Other)
结局指标
主要结局
Barthel Index
时间窗: 16 weeks
Activities of Daily Living will be measured with Barthel Index. The Barthel Index for Activities of Daily Living is an ordinal scale which measures a person's ability to complete activities of daily living (ADL). A score of 95 or 100 (the Barthel Index was measured in 5-point increments between 0 and 100) was considered a favorable outcome.
Berg Balance Scale
时间窗: 16 weeks
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Fugal-Meyer Scale
时间窗: 16 weeks
Motor Function will be measured with Fugal-Meyer Scale. Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.
次要结局
未报告次要终点