Immediate Effect of 360° Virtual Reality Video-viewing on Parameters of Gait in Individuals with Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1) Wisconsin Gait Scale (WGS)
研究概览
简要总结
Stroke can lead to severe physical dysfunction of limbs, impaired balance, cognition and sensation which leads to functional limitations and disabilities.
Gait re-training after a stroke requires constant, reinforced real-world like environmental conditions and situations during training. Virtual reality is used to artificially stimulate visual and proprioceptive information by providing an immersive experience.
Movements practiced in such a virtual environment that closely mimics real-world tasks have been shown to maximize the effects of training which is an advantage of VR therapy.
The purpose of this study is therefore to give stroke patients an immersive 360° VR experience of walking that is more correct than their present activity pattern and ascertain its immediate effect on improving gait may also be more feasible to practice in clinical setting.
It is one-time experimental study requiring a total of 1 or 2 routine visits in which participants will be screened and evaluated for 10-15 minutes and VR treatment will take 15-20 minutes. Sample size of the study is 30 participants who will come routinely to neuro physiotherapy rehabilitation OPD.
If they agree to give consent to participate in this study, they will be asked about a) previous medical and surgical history, current health status and medications. b) undergo a brief physical examination i.e. observational gait analysis and one leg stance time.
The study staff will review the results of these evaluation and test. If you are eligible to participate you will be taken in the study. In that visit pre-evaluation of observational gait analysis and one leg stance time. 360° VR video-viewing treatment will be given via a head-mount VR headset, for total of 2 minutes, twice. Post intervention evaluation of gait parameters and single leg stance time will be done.
The collected data will be tabulated and analyzed using Microsoft Excel and SPSS version 26 (IBM). The difference between pre-intervention and postintervention gait parameters will be calculated and their clinical significance will be investigated.
The statistical analysis will be carried out by first checking the values of WGS Score and Single limb stance test parameters for normality. Normality of the data will be checked. Depending on normality, Paired T Test (Parametric) or Wilcoxon Signed Rank test (non-parametric) will be used to compare pre post total score, sub scales and sub items of Wisconsin Gait Scale and the Single Limb Stance time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Stroke patients between the ages of 30 to 60 who are medically stable Patients of both genders with incidence of first stroke Ambulatory hemiparetic patients Patients willing to participate in the study.
排除标准
- •Severe cognitive impairment (MMSE score less than 18) Severe forms of unilateral spatial neglect, screened using the Bell’s Test (cut off score more than or equal to 50 percent) Severe ideomotor apraxia screened using the Apraxia Screen of TULIA (AST) (cut off score less than 5) Severe anosognosia screened using the Visual- Analogue Test Assessing Anosognosia for Motor Impairment (VATA-M) (cut off score for lower limb more than or equal to +6) Severe visual field of view deficits screened using Confrontation Visual Fields method VAS for pain during ambulation is more than 4 Drug resistant epilepsy or hypertension.
结局指标
主要结局
1) Wisconsin Gait Scale (WGS)
时间窗: 1. Baseline | 2. Pre-intervention | 3. Post-intervention
2) Single Limb Stance Time (SLT)
时间窗: 1. Baseline | 2. Pre-intervention | 3. Post-intervention
次要结局
未报告次要终点