Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193539
• Other study ID #: 2016-07-012-021
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: October 21, 2019

Study information

• Verified date: January 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 21, 2019
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment for Upper Extremity score	range (0-126), higher scores mean a better motor function	Baseline
Primary	Fugl-Meyer Assessment for Upper Extremity score	range (0-126), higher scores mean a better motor function	2 weeks after intervention
Secondary	Box and Block Test	higher scores mean a worse motor function	Baseline
Secondary	Box and Block Test	higher scores mean a worse motor function	2 weeks after intervention
Secondary	Modified Barthel Index	range (0-100), higher scores mean a better activity of daily living	Baseline
Secondary	Modified Barthel Index	range (0-100), higher scores mean a better activity of daily living	2 weeks after intervention
Secondary	Motor Activity Log of Amount of Use and Quality of Movement	range (0-150), higher scores mean a better activity of daily living	Baseline
Secondary	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
Secondary	EuroQol Visual Analogue Scale	range (0-100), higher scores mean a better quality of life	Baseline
Secondary	EuroQol Visual Analogue Scale	range (0-100), higher scores mean a better quality of life	2 weeks after intervention
Secondary	Berg Balance Scale	range (0-56), higher scores mean a better balance function	Baseline
Secondary	Berg Balance Scale	range (0-56), higher scores mean a better balance function	2 weeks after intervention
Secondary	Grip strength (kg)	higher scores mean a better hand function	Baseline
Secondary	Grip strength (kg)	higher scores mean a better hand function	2 weeks after intervention
Secondary	Hand response reaction time	higher scores mean a worse hand function	Baseline
Secondary	Hand response reaction time	higher scores mean a worse hand function	2 weeks after intervention