Clinical trial NCT06582303: Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation
Official title: Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Subacute
Keywords: VR games
Visual feedback
Intervention
Stroke
Lead sponsor: National University of Science and Technology, Pakistan
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subacute stroke patients were randomly assigned to the experimental group and the control group. The experimental group received a VR hand game intervention along with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks. The VR intervention consists of four games that utilize a virtual reality device and are controlled by affected hand movements such as flexion/extension, close/open, supination/pronation, and pinch. The control group and experimental groups received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The field of stroke rehabilitation frequently faces limitations in therapies and struggles to achieve long-lasting improvements in hand motor function. The integration of fully immersive virtual reality (VR) games with visual training feedback significantly improves the efficacy of stroke rehabilitation. Virtual reality (VR) games that incorporate repetitive and particular tasks stimulate the gradual activation of brain pathways linked to motor activities. VR research has the potential to enhance VR intervention games by combining cognitive engagement with visual feedback.

The objective of this study was to develop and evaluate virtual reality games that utilize an approach of cognitive engagement within visual feedback in order to enhance hand-motor capabilities. The study utilized completely immersive virtual reality (VR) games specifically designed for subacute stroke patients. The implementation of fully immersive virtual reality (VR) games as an intervention proved to be highly effective in significantly maintaining the motor recovery of patients who had experienced a stroke in the subacute phase. Stroke patients exhibited enhanced dexterity, heightened range of motion, greater hand strength, and improved grip.

Developed VR games utilize a virtual reality device and are designed to be controlled by hand movements such as flexion/extension, close/open, supination/pronation, and pinch. Patients were randomly assigned to the experimental and control groups. The experimental group received a VR hand game intervention with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Montreal Cognitive Assessment (MOCA ≥ 21)
* Modified Ashworth Scale (MAS\< 4)
* Fugl-Meyer Assessment (FMA between 25 and 55)
* Age ≥ 18 years
* Stroke patient type (Subacute patients)

Exclusion Criteria:

* Wrist Impairments
* Contractures
* Patients with vestibular issues
* Permanent external fixation

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
timeFrame: Baseline, 4th week, 6th week, and 9th week (follow-up)
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline, 4th week, 6th week, and 9th week (follow-up)
measure: Box and Block Test (BBT)
timeFrame: Baseline, 4th week, 6th week, and 9th week (follow-up)
measure: Correlation between electromyography signal features and clinical outcomes
timeFrame: Baseline, 4th week, 6th week, and 9th week (follow-up)
measure: Movement performance
timeFrame: Baseline, 4th week, 6th week, and 9th week (follow-up)
Secondary outcomes:
measure: Modified Barthel Index (MBI)
timeFrame: Baseline and 9th week (follow-up)
measure: Stroke-Specific Quality of Life (SSQOL)
timeFrame: Baseline and 9th week (follow-up)
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Physiotherapy Department, Holy Family Hospital.
state: Punjab
Study officials:
affiliation: National University of Sciences and Technology (NUST), Islamabad, Pakistan
name: Asim Waris, PhD
role: STUDY_CHAIR
References:
citation: Bae S, Park HS. Development of Immersive Virtual Reality-Based Hand Rehabilitation System Using a Gesture-Controlled Rhythm Game With Vibrotactile Feedback: An fNIRS Pilot Study. IEEE Trans Neural Syst Rehabil Eng. 2023;31:3732-3743. doi: 10.1109/TNSRE.2023.3312336. Epub 2023 Sep 28.
citation: Fregna G, Schincaglia N, Baroni A, Straudi S, Casile A. A novel immersive virtual reality environment for the motor rehabilitation of stroke patients: A feasibility study. Front Robot AI. 2022 Aug 29;9:906424. doi: 10.3389/frobt.2022.906424. eCollection 2022.
citation: Lange B, Koenig S, Chang CY, McConnell E, Suma E, Bolas M, Rizzo A. Designing informed game-based rehabilitation tasks leveraging advances in virtual reality. Disabil Rehabil. 2012;34(22):1863-70. doi: 10.3109/09638288.2012.670029. Epub 2012 Apr 12.
citation: Hernandez A, Bubyr L, Archambault PS, Higgins J, Levin MF, Kairy D. Virtual Reality-Based Rehabilitation as a Feasible and Engaging Tool for the Management of Chronic Poststroke Upper-Extremity Function Recovery: Randomized Controlled Trial. JMIR Serious Games. 2022 Sep 27;10(3):e37506. doi: 10.2196/37506.
citation: Huang J, Lin M, Fu J, Sun Y, Fang Q. An Immersive Motor Imagery Training System for Post-Stroke Rehabilitation Combining VR and EMG-based Real-Time Feedback. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:7590-7593. doi: 10.1109/EMBC46164.2021.9629767.
citation: Amin F, Waris A, Syed S, Amjad I, Umar M, Iqbal J, Omer Gilani S. Effectiveness of Immersive Virtual Reality-Based Hand Rehabilitation Games for Improving Hand Motor Functions in Subacute Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2024;32:2060-2069. doi: 10.1109/TNSRE.2024.3405852. Epub 2024 May 30.