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临床试验/NCT07018336
NCT07018336招募中不适用

Comparison of the Acute Effects of Mirror Therapy and Virtual Reality Therapy on Upper Extremity Function and Performance in Hemiplegic Patients

Istinye University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

研究概览

简要总结

Upper extremity impairment in hemiplegic patients significantly impacts daily activities and reduces quality of life. Although traditional rehabilitation methods can help, some patients experience limited progress. Recently, modern techniques such as mirror therapy and virtual reality (VR) have emerged, demonstrating promising results in motor skill improvement.

This study aims to directly compare the acute effects of mirror therapy and VR therapy on upper limb motor function in hemiplegic patients. Forty-two participants aged 18-75 with hemiplegia due to stroke (6-12 months post-stroke) will be randomly assigned to either mirror therapy or VR therapy. The evaluation includes motor function (Fugl-Meyer Assessment), spasticity (Modified Ashworth Scale), activities of daily living (Barthel Index), fine motor skills (Box and Block Test), proprioception, and reaction time.

The goal is to identify the effectiveness of the mirror therapy and VR therapy on motor function, spasticity control, proprioception, daily activity performance, and reaction times, contributing valuable insights to clinical rehabilitation practices.

详细描述

This study aims to comprehensively investigate and directly compare the immediate neurophysiological and functional effects of two innovative neurorehabilitation techniques-mirror therapy and virtual reality (VR) therapy-on upper extremity motor function among patients with hemiplegia following stroke. A total of 42 participants diagnosed with hemiplegia post-stroke will be randomly assigned to either Group A or Group B. Each participant will receive a single, structured intervention session lasting 30 minutes, designed to promote immediate motor recovery through targeted neuroplasticity-enhancing tasks.

Group A : Mirror Therapy Protocol: Participants will be seated comfortably in a stable and ergonomically supportive chair. A mirror measuring approximately 40 cm by 50 cm will be strategically positioned along the mid-sagittal plane, effectively reflecting the unaffected limb and creating the visual illusion of bilateral symmetrical movements. This visual feedback aims to activate motor-related cortical regions within the affected hemisphere, thus enhancing immediate functional motor improvements. Participants will engage in structured therapeutic exercises, each carefully designed to target various aspects of upper limb motor function:

  • Reaching Task: Participants will perform reaching movements towards standardized objects positioned at varying distances and spatial orientations. They will complete 3 sets of 10 repetitions, progressively challenging their spatial accuracy, visual-motor integration, and motor planning skills.
  • Joint Range Movements: Participants will execute comprehensive movements involving finger flexion-extension, wrist flexion-extension, elbow flexion-extension, and shoulder flexion-abduction. Each movement will be repeated 10 times, systematically activating multiple joints and muscles to promote functional range of motion and coordination.
  • Grasp and Release Exercises: Participants will complete grasping and releasing tasks with objects of different sizes, textures, and weights. This task includes 3 sets of 10 repetitions designed to enhance tactile feedback, grip strength, fine motor coordination, and functional hand dexterity.

Group B: Virtual Reality (VR) Therapy: Participants in the VR group will utilize advanced virtual reality equipment, including high-resolution VR headsets and handheld controllers, immersing themselves in an interactive, three-dimensional virtual environment. This environment is specifically developed to simulate realistic and engaging scenarios, enhancing ecological validity, motivation, and patient engagement through multisensory stimulation. Therapeutic tasks in the VR environment will mirror those in the mirror therapy protocol to facilitate direct comparative analysis:

  • Virtual Reaching Tasks: Participants will perform interactive tasks, engaging in accurate reaching movements toward virtual targets displayed at various locations and distances within the virtual environment, emphasizing hand-eye coordination and spatial orientation.
  • Virtual Joint Movements: Virtual tasks will guide participants through movements involving finger flexion-extension, wrist flexion-extension, elbow flexion-extension, and shoulder flexion-abduction. Visual and auditory cues in the VR environment will enhance proprioceptive feedback and facilitate precise motor execution.
  • Virtual Grasp and Release Tasks: Participants will virtually grasp and manipulate various digital objects, practicing controlled grasp and release movements that mimic real-world functional tasks. Task complexity will vary to address different aspects of motor control, strength, and dexterity.

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 (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemiplegic patients in need of upper extremity rehabilitation.
  • Having had a stroke 6 to 12 months prior to the study.
  • Being at least Stage 3 for the upper extremity according to the Brunnstrom motor recovery stages.
  • Age range: between 18 and 75 years.
  • Individuals who volunteer to participate in the study.
  • Individuals who are cognitively suitable for mirror therapy and virtual reality applications (a score of at least 24 on the Mini Mental State Examination)

排除标准

  • Patients with severe spasticity (score ≥ 3 on the Modified Ashworth Scale)
  • Individuals with secondary neurological conditions (e.g., Parkinson's disease, multiple sclerosis).
  • Individuals diagnosed with vestibular dysfunction (as virtual reality equipment may cause issues like nausea or dizziness).
  • Individuals with communication issues, such as hearing or vision loss.

研究组 & 干预措施

Mirror Therapy

Experimental

Participants will receive a single 30-minute session of mirror therapy applied to the affected upper extremity. The therapy will involve performing functional upper limb movements while viewing the mirror reflection of the unaffected limb to create the visual illusion of symmetrical bilateral movement.

干预措施: Mirror Therapy (Other)

Virtual Reality (VR) Therapy

Experimental

Participants in this group will receive a single 30-minute session of virtual reality-based upper extremity rehabilitation using a Meta Quest 2 head-mounted display. The intervention will consist of task-oriented, interactive exercises targeting shoulder, elbow, wrist, and hand movements. The session will be conducted under supervision to ensure safety and proper task performance.

干预措施: Virtual Reality (VR) Therapy (Device)

结局指标

主要结局

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

时间窗: Day 1

The Fugl-Meyer Assessment is a standardized and widely used tool designed to evaluate motor function, balance, sensation, and joint functioning in individuals with post-stroke hemiplegia. In this study, only the upper extremity motor domain will be used, which includes evaluation of movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. The assessment is scored on a 3-point ordinal scale: 0 (cannot perform), 1 (performs partially), and 2 (performs fully), with a maximum score of 66 indicating better motor recovery. Participants are seated or lying in a comfortable position during the test, and each movement is explained and demonstrated. The researcher scores the quality and completion of each movement. The FMA-UE is a valid and reliable measure of motor function and is widely used in stroke rehabilitation research

Box and Block Test (BBT)

时间窗: Day 1

The Box and Block Test (BBT) is a standardized assessment of unilateral gross manual dexterity. Participants are instructed to transfer as many wooden blocks as possible from one compartment of a box to the other within 60 seconds using one hand. The number of successfully transferred blocks is recorded as the score. The test is widely recognized for its simplicity, reliability, and sensitivity in detecting changes in motor function, especially in post-stroke patients. In this study, the BBT will be used to evaluate changes in upper extremity motor performance and coordination immediately before and after the intervention session.

次要结局

  • Modified Ashworth Scale (MAS)(Day 1)
  • joint Position Sense Test (Proprioception Assessment)(Day 1)
  • Simple Reaction Time (SRT) with BlazePod(Day 1)
  • Global Rating of Change (GRC) scale(Day 1)
  • Barthel Index (Activities of Daily Living - ADL)(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Çiçek Günday

Asst. Prof.

Istinye University

研究点 (1)

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