CVA (Cerebrovascular Accident), Stroke, Stroke, Ischemic
Conditions
Keywords
robotic rehabilitation, mirror therapy, stroke rehabilitation, neurorehabilitation
Brief summary
The goal of this clinical trial is to compare the effectiveness of conventional mirror therapy and robotic mirror mode training in promoting upper extremity motor recovery in adult patients with ischemic stroke during the early subacute phase. The main questions it aims to answer are: Does mirror mode of a robotic hand device result in greater motor function recovery compared to conventional mirror therapy? Are there differences between the groups in somatosensory improvement and gross motor skill outcomes? Do both intervention modalities result in clinically significant improvements in motor and functional outcomes? Researchers will compare a conventional mirror therapy group and a robotic-assisted mirror mode group to determine which provides more significant gains in motor function, somatosensory input, and functional use of the paretic arm. Participants will: Receive standard physiotherapy sessions for 6 weeks Be randomly assigned to either mirror therapy or robotic mirror mode intervention Be evaluated using Fugl-Meyer Assessment, ARAT, Box and Block Test, Wolf Motor Function Test and Tactile/proprioceptive sensory test using Fugl-Meyer Assessment Sensory subsection.
Detailed description
Upper extremity motor impairment is one of the leading causes of functional disability following stroke. Although conventional therapies promote some degree of recovery, restoring hand function remains a major challenge, particularly in patients with severe paresis. Mirror therapy has been widely used due to its affordability and portability. However, proprioceptive feedback limitations and the potential mismatch between visual and somatosensory input reduce its effectiveness. This study investigates an innovative approach that combines visual illusion and proprioceptive input using a robotic hand device in mirror mode. The robotic intervention is designed to synchronize joint motion with visual feedback, potentially enhancing the mirror neuron system's activation and promoting neuroplastic changes more efficiently than conventional mirror therapy. The study will be conducted over a 6-week period with stroke patients in the early subacute phase. Both groups will receive equivalent durations of upper limb training in addition to conventional physiotherapy. This trial aims not only to compare motor outcomes but also to evaluate whether motor improvements translate into functional hand use and to explore differences in somatosensory gains between interventions. By addressing both visual and proprioceptive components of motor learning, this research may guide future clinical strategies for individualized stroke rehabilitation.
Interventions
DEVICEHand Robot Mirror Mode
Mirror mode of the hand robot group will mimic the movement of the unaffected arm. The robot will provide proprioceptive and visual feedback and make patient believe that the affected arm is moving.
DEVICETherapy Mirror
Patients in the mirror therapy group will glance at the reflection of their non-affected arm and fall into the illusion that their non-affected limb is moving. This is supposed to assist patients regain motor deficits by reducing non-use paralysis.
Sponsors
Zeynep Lide Uz
The Scientific and Technological Research Council of Turkey
Istanbul University - Cerrahpasa
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention, participant and therapist blinding was not feasible, and outcome assessments were performed without masking.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having a ischemic/hemorrhagic stroke diagnosis through MRI and/or CT * Volunteering to enter the study * First ever stroke or no sequeale (mRS 0) * Being in subacute/chronic phase of stroke (between 1st week to 1 year) * Having a adequate sitting balance or able to maintain upright sitting position for 30 minutes * Having a motor deficit in the hand (Brunnstrom hand motor recovery stages 1-4 ) * Having a full range of motion in hand
Exclusion criteria
* Severe Pain (VAS ≥ 8) * Having a neurological or orthopedic problem in hand * Severe spatial hemineglect (NIHSS 11th subscale\> 1) * Spasticity (mAS ≥ 2) * Apraxia * Visual/auditory loss that affects treatment * Unstable Vital Signs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Assesment | 30 minutes | The Fugl-Meyer Assessment-Upper Extremity is a stroke-specific, performance-based impairment scale and gold-standard measure of post-stroke motor recovery that quantifies upper limb motor function using a standardized ordinal scoring system assessing reflex activity, movement control, coordination, and joint function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | 15 minutes | The Action Research Arm Test (ARAT) is a performance-based assessment designed to evaluate upper limb function by measuring the ability to grasp, grip, pinch, and perform gross motor movements. It is particularly sensitive to changes in hand and arm function after stroke and is frequently used in both clinical and research settings to monitor motor recovery. |
| Wolf Motor Function Test | 30 minutes | The Wolf Motor Function Test (WMFT) is a widely used, time-based assessment that evaluates upper extremity motor ability through a series of functional and strength-related tasks in individuals with stroke. It measures both the time taken to complete 15 standardized activities and the quality of movement, providing objective data on motor recovery. |
| Box and Block Test | 5 minutes | The Box and Block Test is a standardized, performance-based measure of gross manual dexterity that quantifies upper extremity function by counting the number of blocks transferred within 60 seconds. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTOREla Tarakcı, 1
Istanbul University- Cerrahapaşa
Outcome results
None listed