Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation
NCT Number: NCT06582303
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Subacute
Interventions: DEVICE: Virtual reality Game intervention plus conventional physical therapy|DEVICE: Conventional Physical Therapy
Sponsor: National University of Science and Technology, Pakistan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-14
Completion Date: 2023-07-31
Locations: Physiotherapy Department, Holy Family Hospital., Rawalpindi, Punjab, 46000, Pakistan

Summary:
The study was a randomized control trial conducted to determine whether VR games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. An investigation has been conducted to assess the efficacy of virtual reality games that enhance hand motor functions to attain long-lasting improvements. Patients were randomly assigned to the experimental and control groups. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week, for a total duration of 6 weeks. Developed four VR-based hand games that include hitting a rolling ball, grasping a balloon, swapping hands, and gripping a pencil.

Primary Outcome Measures: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), The Fugl-Meyer Assessment-Upper Extremity subscale was employed to examine the motor function restoration in the upper extremity of stroke patients following interventions. The Fugl-Meyer Assessment-Upper Extremity consists of 33 items that assess motor function, with a scoring range of 0-66, The minimum score 0 represents severe impairment, and maximum score 66 represents normal motor function. Higher scores indicate better motor function., Baseline, 4th week, 6th week, and 9th week (follow-up)|Action Research Arm Test (ARAT), The Action Research Arm Test is utilized to examine the functional capabilities of stroke patients upper extremities, specifically in terms of reaching, gripping, pinching, and overall movement tasks. Each item is allocated a rating score of 4 points, with the potential total values ranging from 0 to 57. The minimum score 0 represents severe impairment, and the maximum score 57 represents normal upper extremity function. Higher scores on the Action Research Arm Test indicate better functional capabilities of the upper extremities., Baseline, 4th week, 6th week, and 9th week (follow-up)|Box and Block Test (BBT), The BBT evaluated the manual dexterity of individuals who had suffered a stroke. During this assessment, participants are required to transfer blocks from one container to another within a one-minute time limit., Baseline, 4th week, 6th week, and 9th week (follow-up)|Correlation between electromyography signal features and clinical outcomes, Electromyography signals are obtained in order to evaluate the electrical activity generated by muscles. Electromyography was utilized for the objective assessment of the effectiveness of immersive VR-based hand games. The objective assessment includes the evaluation of the correlation between electromyography signal features and clinical outcomes, which includes the Fugl-Meyer Assessment-Upper Extremity, Action Research Arm Test, and Box and Block Test., Baseline, 4th week, 6th week, and 9th week (follow-up)|Movement performance, The weekly movement performance was evaluated by machine learning algorithms that include k-nearest neighbors, random forest, and support vector machine classifiers on the electromyography signals of stroke patients., Baseline, 4th week, 6th week, and 9th week (follow-up)
Secondary Outcome Measures: Modified Barthel Index (MBI), The Modified Barthel Index assesses an individual\&#39;s ability to perform both practical and routine tasks independently. The Modified Barthel Index consists of 10 items, each scored based on the level of assistance required or the level of autonomy demonstrated by the patient. The total score ranges from a minimum of 0 to a maximum of 20. Lower scores indicate greater dependence, with scores below 10 typically representing severe disability and scores below 15 usually indicating moderate disability. Moreover, higher scores reflect greater independence in performing daily activities., Baseline and 9th week (follow-up)|Stroke-Specific Quality of Life (SSQOL), The Stroke-Specific Quality of Life measure was used to assess the health-related quality of life of stroke survivors. The Stroke-Specific Quality of Life scale consists of 49 comprehensive items that evaluate various aspects of quality of life based on the patient's current state. The total score ranges from a minimum of 49 to a maximum of 245. Lower scores indicate poorer health-related quality of life, and higher scores indicate better health-related quality of life., Baseline and 9th week (follow-up)