İstinye Üniversite Hastanesi Medical Park Gaziosmanpaşa
Istanbul, Gaziosmanpaşa, 34065, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07018336
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Istanbul, Gaziosmanpaşa, 34065, Turkey (Türkiye)
Location status: Recruiting
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:
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:
Assessment Methods: Objective and reliable clinical assessments will be conducted immediately before and after each therapy session to measure changes in motor function, muscle tone, sensory-motor integration, and functional independence. The assessments will include:
This multidimensional assessment approach ensures a detailed evaluation of the acute therapeutic impacts of each intervention. By systematically comparing the immediate effectiveness and therapeutic advantages of mirror therapy and virtual reality therapy, this study aims to generate evidence-based recommendations, contributing significantly to clinical decision-making processes and potentially optimizing rehabilitation strategies for individuals recovering from stroke-related hemiplegia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mirror therapy will be applied to the affected upper extremity by placing a mirror in the midsagittal plane to reflect movements of the non-paretic limb, creating the visual illusion of symmetrical bilateral movement. Participants will perform task-specific functional movements of the hand and arm (e.g., grasping, wrist flexion, and extension) while focusing on the mirror image.
Virtual reality therapy will be delivered using the Meta Quest 2 head-mounted display system. Participants will engage in interactive, task-specific upper extremity exercises designed to promote motor activation and functional movement of the affected limb through immersive visual feedback.
Time frame: 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
Time frame: 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.
Time frame: Day 1
The Modified Ashworth Scale (MAS) is used to assess muscle spasticity by measuring resistance during passive soft-tissue stretching. It is a reliable clinical tool commonly used in neurological rehabilitation settings, especially in stroke patients. During the assessment, the target limb is passively moved through its range of motion, and the resistance to movement is rated on a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Participants are placed in a neutral and relaxed position during testing to ensure consistency. The evaluation will be conducted on the upper extremity muscles involved in voluntary function, and changes in MAS scores will be recorded to determine immediate effects of the intervention on spasticity levels.
Time frame: Day 1
The Joint Position Sense Test assesses proprioceptive accuracy by evaluating a participant's ability to replicate specific joint angles with the opposite limb while blindfolded or with eyes closed. For this study, the test involves passive positioning of the affected upper limb at predetermined target angles (e.g., 60° and 100° of shoulder flexion), which participants will then attempt to match with the contralateral limb. The difference in angle reproduction is used as a measure of proprioceptive acuity. This method provides insight into sensorimotor integration deficits common in hemiplegic patients and will be used to assess changes before and after the intervention
Time frame: Day 1
Simple Reaction Time (SRT) is a measure of how quickly an individual responds to a single stimulus. In this study, SRT will be evaluated using BlazePod light pods, which emit visual cues in a random sequence. Participants, seated comfortably with their hands resting near the pods, will be instructed to tap the lit pod as quickly as possible upon activation. The device records the reaction time in milliseconds. This test provides valuable information about the efficiency of sensorimotor integration and central processing speed. It is particularly relevant in stroke rehabilitation, where improvements in reaction time often correlate with better functional recovery.
Time frame: Day 1
The Global Rating of Change (GRC) scale is a subjective measure used to evaluate a patient's perceived improvement or deterioration in their health status over time. It is particularly useful in musculoskeletal and neurorehabilitation studies. In this study, participants will be asked to compare their current condition to their pre-treatment condition immediately after the therapy session. The version used includes a 5-point Likert scale ranging from -2 to +2, where: -2 = much worse, -1 = slightly worse, 0 = no change, +1 = slightly better, and +2 = much better. This simple, patient-centered outcome allows us to capture overall satisfaction and perceived effectiveness of the therapy from the patient's perspective.
Time frame: Day 1
The Barthel Index evaluates a patient's ability to perform basic activities of daily living (ADLs) independently. It assesses ten functional areas including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair climbing. Each task is scored according to the level of assistance required, with a maximum total score of 100 indicating complete independence. The index is widely used in stroke rehabilitation to assess functional outcomes and monitor improvements over time. In this study, the Barthel Index will be administered before and immediately after the intervention to measure short-term functional changes in ADL performance among hemiplegic patients.
Contact information is provided by the study sponsor or research team.
Maysaa Hamdy Othman Ibrahim, Physiotherapist
CONTACT
Çiçek Günday, Asst. Prof.
CONTACT
Istinye University
Other
Comparison of the Acute Effects of Mirror Therapy and Virtual Reality Therapy on Upper Extremity Function and Performance in Hemiplegic Patients
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