Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study was to assess the efficacy of augmented and virtual reality-based rehabilitation programs on improving upper extremity function in subacute stroke patients.

Detailed Description
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This was a randomized, single-blinded study, conducted at a single acute rehabilitation unit in a university hospital. In this study, the effect of augmented and virtual reality-based rehabilitation for the recovery of subacute stroke patients compared with conventional occupational therapy was evaluated.

Official Title
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Effects of Comprehensive Augmented and Virtual Reality for Upper Limb Rehabilitation in First-Ever Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Augmented reality and virtual reality rehabilitation
* Behavioral: Conventional occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First ever stroke Onset of stroke less than 3 months Sufficiently medically stable to participate in active rehabilitation Mild-to-moderate upper extremity motor impairments (Brunnstrom stage for the upper extremity 2-6). Exclusion Criteria: Severe cognitive impairment (defined as score < 10 on the Mini-Mental State Examination) Evidence of apraxia Clinical history of neglect Previous upper extremity hemiplegia.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, single-blinded study. Individuals were randomly assigned to either the experimental group or control group using a computer-generated randomization technique. The randomization list was created on blocks of four and generated at the start of the study using a computerized program.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented reality and virtual reality rehabilitation<br>This group underwent augmented reality and virtual reality rehabilitation for 60 minutes per session, 5 days per week for 2 weeks. | Behavioral: Augmented reality and virtual reality rehabilitation<br>* This group underwent augmented reality and virtual reality rehabilitation with 4 different systems. The RAPAEL Smart Glove® is a wearable sensory system that contains a single 9-axis movement and position sensor with 3 acceleration channels, 3 angular rate channels, and 3 magnetic field channels that measures wrist movements, and 5 bending sensors that measure finger movements. The RAPAEL Smart Board® is a rehabilitation system used to improve arm function by practicing gravity-compensated movements. The RehabMaster® is a game-based Kinect sensor AR rehabilitation system which uses a 3D camera to digitize patient movements and quickly analyze their range of motion, speed, motion angle, and movement cycles. rehabilitation exercise using games to encourage active arm and trunk movements and promote successful rehabilitation. The COG-Trainer® is a VR system that uses a training device synchronized with the screen through simulation.<br>|
| Active Comparator: Conventional occupational therapy<br>This group underwent conventional occutational therapy for 60 minutes per session, 5 days per week for 2 weeks. | Behavioral: Conventional occupational therapy<br>* The group underwent standard ocupational therapy, such as range of motion and strengthening exercises for the affected upper extremity, table-top activities, and training for activities of daily living.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment for Upper Extremity score | range (0-126), higher scores mean a better motor function | Baseline | 
| Fugl-Meyer Assessment for Upper Extremity score | range (0-126), higher scores mean a better motor function | 2 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block Test | higher scores mean a worse motor function | Baseline | 
| Box and Block Test | higher scores mean a worse motor function | 2 weeks after intervention | 
| Modified Barthel Index | range (0-100), higher scores mean a better activity of daily living | Baseline | 
| Modified Barthel Index | range (0-100), higher scores mean a better activity of daily living | 2 weeks after intervention | 
| Motor Activity Log of Amount of Use and Quality of Movement | range (0-150), higher scores mean a better activity of daily living | Baseline | 
| Motor Activity Log of Amount of Use and Quality of Movement | range (0-150), higher scores mean a better activity of daily living | 2 weeks after intervention | 
| EuroQol Visual Analogue Scale | range (0-100), higher scores mean a better quality of life | Baseline | 
| EuroQol Visual Analogue Scale | range (0-100), higher scores mean a better quality of life | 2 weeks after intervention | 
| Berg Balance Scale | range (0-56), higher scores mean a better balance function | Baseline | 
| Berg Balance Scale | range (0-56), higher scores mean a better balance function | 2 weeks after intervention | 
| Grip strength (kg) | higher scores mean a better hand function | Baseline | 
| Grip strength (kg) | higher scores mean a better hand function | 2 weeks after intervention | 
| Hand response reaction time | higher scores mean a worse hand function | Baseline | 
| Hand response reaction time | higher scores mean a worse hand function | 2 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Augmented Reality