Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Augmented reality and virtual reality rehabilitation; Behavioral: Conventional occupational therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented reality and virtual reality rehabilitation; 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; 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.
Active Comparator: Conventional occupational therapy; This group underwent conventional occutational therapy for 60 minutes per session, 5 days per week for 2 weeks.	Behavioral: Conventional occupational therapy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 25, 2021
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Augmented Reality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016-07-012-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No