About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Virtual Reality
Other interventionCamera controlled virtual reality games for upper extremity
Conventional rehabilitation
Other interventionPersonalized conventional exercises for hemiparesis after stroke
Action observation therapy
Other interventionRehabilitation method that involves patients watching video recordings of purposeful upper extremity movements designed for daily life activities followed by physically attempting the same movements.
Treatment groups
Trial outcomes
Primary outcomes
Fugl-Meyer Upper Extremity
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.
Secondary outcomes
WOLF motor function test - Functional Ability Scale
The Wolf Motor Function Test (WMFT) is an assessment tool developed to evaluate motor skills in patients with upper extremity motor deficits. The test consists of 17 items. For 15 items, data is collected on functional ability and performance time, while 2 items assess muscle strength. 2 tests for muscle strength were not used.Each activity is scored on a Functional Ability Scale ranging from 0 to 5, where 0 indicates no use of the affected limb during the activity, and 5 represents normal movement. An average score is calculated for the Functional Ability Scale, with higher scores indicating better motor function. A Turkish version of the WMFT has also been validated and found reliable for use in stroke patients.
Motricity Index - Upper Extremity
The Motricity Index is a scale used to determine patients' motor function levels. In our study, the Motricity Index - Upper Extremity score will be calculated to evaluate upper limb function following stroke. The minimum score is 0 and the maximum score is 99. A Turkish version of the motricity index has been validated and found reliable for use.
Stroke Impact Scale 3.0:
The Stroke Impact Scale is a stroke-specific health status measure designed to assess the quality of life and functional independence of patients after stroke. It allows both patients and their caregivers to evaluate the patient's overall condition. The assessment uses a 5-point Likert scale for scoring. Scores for each domain range from 0 to 100. In addition to questions across 8 subdomains, SIS 3.0 includes a visual analog scale to measure perceived recovery after stroke, scored from 0 to 100 (0 = no recovery, 100 = full recovery).
Brunnstrom Upper Extremity and Hand
The Brunnstrom method evaluates motor recovery in stroke patients through six sequential stages. Stage 1 represents the worst condition, characterized by flaccidity and no voluntary movement in the upper extremity. Stage 6 indicates the best outcome, where coordinated, voluntary, and normal movement patterns are fully restored. This scale helps clinicians determine the patient's current recovery stage and plan appropriate rehabilitation strategies.
Sponsors and contacts
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Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead sponsor
Inosens information technologies limited company
Collaborator