Clinical trial NCT07018336: Mirror vs Virtual Reality Therapy for Upper Extremity Function in Hemiplegic Patients
Official title: Comparison of the Acute Effects of Mirror Therapy and Virtual Reality Therapy on Upper Extremity Function and Performance in Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Upper Extremity Dysfunction After the Stroke
Stroke
Upper Extremity Dysfunction
Keywords: Upper Extremity Rehabilitation
Stroke Rehabilitation
Motor Function Recovery
Neurorehabilitation
Virtual Reality Therapy
Mirror Therapy
Upper Extremity Dysfunction
Stroke
Hemiplegia
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 which method provides superior immediate improvements in motor function, spasticity control, proprioception, daily activity performance, and reaction times, contributing valuable insights to clinical rehabilitation practices.

Question the study is trying to answer:

Does mirror therapy or virtual reality therapy provide superior immediate benefits for improving upper extremity motor functions and related clinical outcomes in hemiplegic patients?

Detailed description: 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 the mirror therapy or VR therapy group. Each participant will receive a single, structured intervention session lasting 30 minutes, designed to promote immediate motor recovery through targeted neuroplasticity-enhancing tasks.

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.

The therapist will continuously monitor participant posture, movement accuracy, and compliance with visual and verbal cues throughout the therapy session, making adjustments as necessary to ensure optimal therapy outcomes.

Virtual Reality (VR) Therapy Protocol:

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.

Throughout the VR sessions, therapists will observe participants' performance closely, adjusting the difficulty level and providing supportive feedback tailored to each individual's motor ability and progression.

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:

* Motor Performance: Evaluated by the Fugl-Meyer Motor Assessment (FMA), providing comprehensive data on upper limb motor function.
* Spasticity: Quantified using the Modified Ashworth Scale (MAS), providing reliable measurements of muscle tone.
* Activities of Daily Living (ADL): Assessed with the Barthel Index to objectively measure functional independence and performance in daily activities.
* Fine Motor Skills: Evaluated using the Box and Block Test, offering precise measurement of hand dexterity and coordination.
* Proprioception: Evaluated using standardized joint position matching tasks, assessing sensory-motor integration and proprioceptive accuracy.
* Reaction Time: Assessed via computerized Simple Reaction Time (SRT) testing, precisely measuring sensorimotor responsiveness and processing speed.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: Day 1
measure: Modified Ashworth Scale (MAS)
timeFrame: Day 1
Secondary outcomes:
measure: Barthel Index (Activities of Daily Living - ADL)
timeFrame: Day 1
measure: Box and Block Test (BBT)
timeFrame: Day 1
measure: joint Position Sense Test (Proprioception Assessment)
timeFrame: Day 1
measure: Simple Reaction Time (SRT) with BlazePod
timeFrame: Day 1
measure: Global Rating of Change (GRC) scale
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstinye Üniversite Hastanesi Medical Park Gaziosmanpaşa
state: Gaziosmanpaşa
Study officials:
affiliation: Istinye University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
name: Çiçek Günday, Asst. Prof., Doctor of Physical Therapy
role: PRINCIPAL_INVESTIGATOR
References: