The Effect of Virtual Reality Therapy on Upper Extremity Functions in Subacute Stroke Patients Receiving Conventional Rehabilitation and Action Observation Therapy: A Randomized Controlled Single-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Upper Extremity
研究概览
简要总结
Stroke ranks second among the leading causes of death worldwide and third among the causes of disability. In stroke patients, motor impairment typically affects facial movements and the upper and lower extremities unilaterally. Upper extremity involvement, in particular, negatively impacts patients' activities of daily living, such as eating and dressing. Various rehabilitation methods are used to improve the function of the paretic upper extremity in stroke patients. Action Observation Therapy and Virtual Reality are among the rehabilitation approaches currently used to support upper extremity rehabilitation.
In our study, patients will be randomly divided into two groups: one group will receive conventional rehabilitation and Action Observation Therapy, while the other group will additionally receive Virtual Reality therapy. This study aims to investigate the contribution of Virtual Reality therapy, when added to conventional rehabilitation and Action Observation Therapy, to the recovery of the paretic upper extremity in patients with subacute stroke.
详细描述
Methodology
All volunteer patients will be evaluated at the beginning of the treatment using the following assessment tools: Fugl-Meyer Assessment-Upper Extremity, Brunnstrom Stages-Upper Extremity/Hand, Wolf Motor Function Test, Motricity Index-Arm, Stroke Impact Scale 3.0, and Task-Based Exercises (number of times the patient can bring their hand to the mouth, behind the head, and to the sacrum in one minute).
Patients will be randomly assigned to two groups using computerized randomization.
One group will receive conventional therapy 5 days per week plus Action Observation Therapy (AOT) 3 times per week for 30 minutes.
Each AOT session will consist of videos featuring goal-oriented tasks prepared according to the individual needs of the patient. The videos will change weekly. The first session each week will be supervised by the physician, while the other two sessions will be performed independently by the patient.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18
- •Patients in the subacute phase of stroke (between 6 weeks and 6 months post-stroke)
- •Patients with a first-ever stroke
- •Brunnstrom stage 3 or above for both upper extremity and hand
- •Mini-Mental State Examination (MMSE) score >=20
- •No major medical condition that would prevent participation in the treatment
排除标准
- •Presence of pain in the paretic shoulder severe enough to prevent exercise
- •History of bilateral stroke
- •Patients with global aphasia and/or cognitive impairment that significantly affects treatment compliance
- •Patients with severe visual impairment
- •Presence of unilateral spatial neglect
- •Inability to maintain sitting balance
- •Modified Ashworth Scale > 4 in the hemiplegic arm
研究组 & 干预措施
Virtual Reality
Patients in this group will receive virtual reality rehabilitation for 5 weeks, 3 times a week for a total of 15 sessions. Additionally they will receive conventional rehabilitation six days a week for 5 weeks and action observation therapy for 3 times a week for 5 weeks. For action observation therapy 1 session each week will be done under supervision of principal investigator and 2 sessions will performed independently by the patient
干预措施: Virtual Reality (Other)
Virtual Reality
Patients in this group will receive virtual reality rehabilitation for 5 weeks, 3 times a week for a total of 15 sessions. Additionally they will receive conventional rehabilitation six days a week for 5 weeks and action observation therapy for 3 times a week for 5 weeks. For action observation therapy 1 session each week will be done under supervision of principal investigator and 2 sessions will performed independently by the patient
干预措施: Conventional rehabilitation (Other)
Virtual Reality
Patients in this group will receive virtual reality rehabilitation for 5 weeks, 3 times a week for a total of 15 sessions. Additionally they will receive conventional rehabilitation six days a week for 5 weeks and action observation therapy for 3 times a week for 5 weeks. For action observation therapy 1 session each week will be done under supervision of principal investigator and 2 sessions will performed independently by the patient
干预措施: Action observation therapy (Other)
Control
Patients in this group will receive conventional rehabilitation six days a week for 5 weeks and action observation therapy for 3 times a week for 5 weeks. For action observation therapy 1 session each week will be done under supervision of principal investigator and 2 sessions will performed independently by the patient
干预措施: Conventional rehabilitation (Other)
Control
Patients in this group will receive conventional rehabilitation six days a week for 5 weeks and action observation therapy for 3 times a week for 5 weeks. For action observation therapy 1 session each week will be done under supervision of principal investigator and 2 sessions will performed independently by the patient
干预措施: Action observation therapy (Other)
结局指标
主要结局
Fugl-Meyer Upper Extremity
时间窗: From enrollment to the 1 months after treatment
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a standardized scale used to assess motor recovery of the upper limb in post-stroke patients. It evaluates voluntary movement, reflex activity, coordination, and speed. The scale consists of 33 items, and the total score ranges from 0 to 66, with 0 indicating no motor function and 66 representing normal motor function. A Turkish validity and reliability study has also been conducted for this scale.
次要结局
- WOLF motor function test - Functional Ability Scale(From enrollment to the 1 month after treatment)
- Motricity Index - Upper Extremity(From enrollment to the 1 month after treatment)
- Brunnstrom Upper Extremity and Hand(From enrollment to the 1 month after treatment)
- Task Specific Exercises(From enrollment to the 1 month after treatment)
- The Wolf Motor Function Test (WMFT)- Performance Time(From enrollment to the 1 month after treatment)
- Stroke Impact Scale 3.0:(From enrollment to the 1 month after treatment)
研究者
Seda Akbayrak
Resident Doctor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital