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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05193539
Enrollment
30
Registered
2022-01-18
Start date
2018-11-19
Completion date
2019-10-21
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Virtual Reality, Augmented Reality

Brief 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.

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.

Interventions

BEHAVIORALAugmented 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.

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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment for Upper Extremity scoreBaselinerange (0-126), higher scores mean a better motor function

Secondary

MeasureTime frameDescription
Modified Barthel IndexBaselinerange (0-100), higher scores mean a better activity of daily living
Motor Activity Log of Amount of Use and Quality of MovementBaselinerange (0-150), higher scores mean a better activity of daily living
EuroQol Visual Analogue ScaleBaselinerange (0-100), higher scores mean a better quality of life
Box and Block TestBaselinehigher scores mean a worse motor function
Grip strength (kg)Baselinehigher scores mean a better hand function
Hand response reaction timeBaselinehigher scores mean a worse hand function
Berg Balance ScaleBaselinerange (0-56), higher scores mean a better balance function

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026