Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

NCT ID: NCT05193539

Last Updated: 2022-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-10-21

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The researcher responsible for randomization was independent from the assessors, assuring blindness to treatment allocation and randomization procedures. The blinded assessor performed the baseline and post-treatment assessments. The patients and the occupational therapists were not blinded due to the nature of treatment modality.

Study Groups

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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.

Group Type EXPERIMENTAL

Augmented reality and virtual reality rehabilitation

Intervention Type BEHAVIORAL

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

This group underwent conventional occutational therapy for 60 minutes per session, 5 days per week for 2 weeks.

Group Type ACTIVE_COMPARATOR

Conventional occupational therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Geol Do

M.D, PhD, Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2016-07-012-021

Identifier Type: -

Identifier Source: org_study_id

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