A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment- Lower Extremity
研究概览
简要总结
This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.
详细描述
This was single-blind randomized controlled intervention study. Each stroke subject underwent screening period, baseline assessment period, intervention period, endpoint assessment period.
The screening period include the verification of inclusion/exclusion criteria and the acquisition of informed consent.
Baseline and endpoint assessment period include motor function related scales were evaluated (muscle strength, muscle tone, Fugl-Meyer scale, Berg balance scale); cognitive function related scale assessment [Brief Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test, Shape connection test A.B, standardized digital modal experiment, auditory word Learning Test], emotional correlation scale assessment (Hamilton Depression Scale, Hamilton Anxiety Scale), and activity of daily living scale ADL scale. Meanwhile, quantitative evaluation of motor function three-dimensional gait detection and assessment of brain functional activation (fNIRs tests and fMRI) were synchronously completed.
The intervention period included multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity in the experimental group and only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
Preliminary validation of effectiveness assessment includes Fugl-Meyer scale, Berg balance scale, and three-dimensional gait detection. Preliminary validation of the safety assessment includes fall and dizzy incidents.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The first onset of stroke is diagnosed and confirmed according to the requirements of stroke
- •The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is less than
- •18-85 years of age.
- •Able to walk with minor assistance
- •MMSE score of 20-30 and ability to understand and follow instructions during the trial
- •Able to sign an informed consent form.
排除标准
- •Severe visual or hearing impairments.
- •Pregnant or breastfeeding women.
- •Patients with unrepaired cranial bone flaps or metallic implants following brain surgery.
- •Presence of other conditions affecting lower limb motor function, such as osteoarthritis or recent lower limb fractures.
- •History of severe psychiatric disorders, other neurological diseases, acute cardiopulmonary dysfunction, multiple organ failure, brain tumours, or epilepsy.
研究组 & 干预措施
VR+treadmill training group
Multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
干预措施: multi-sensory stimulation immersive VR+ treadmill training (Device)
treadmill training group
Only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
干预措施: treadmill training (Device)
结局指标
主要结局
Fugl-Meyer Assessment- Lower Extremity
时间窗: 30 days (Adjust according to the actual situation of patients)
The Fugl-Meyer Assessment of Motor Recovery after Stroke - Lower Extremity (FMA-LE) evaluates lower extremity motor impairment through 17 items assessing reflexes, synergy patterns, and coordination. Each item is scored 0-2 (total range 0-34), with higher scores indicating better motor function. The total is the sum of all items, including motor (0-30) and coordination (0-4) subcomponents.
次要结局
- Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2)(30 days (Adjust according to the actual situation of patients))
- Berg balance scale(30 days (Adjust according to the actual situation of patients))
- 3D Gait Analysis - Affected Side Step Width(30 days (Adjust according to the actual situation of patients))
- Montreal Cognitive Assessment（MoCA）(30 days (Adjust according to the actual situation of patients))
- Mini-Mental State Examination (MMSE)(30 days (Adjust according to the actual situation of patients))
研究者
Dingqun Bai
Director, Clinical Professor
First Affiliated Hospital of Chongqing Medical University