Skip to main content
OpenTrials
Completed

NCT Number: NCT05193539

Effects of Comprehensive Augmented and Virtual Reality in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Augmented reality and virtual reality rehabilitation

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

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.

Primary outcomes

  1. Fugl-Meyer Assessment for Upper Extremity score

    Time frame: Baseline

    range (0-126), higher scores mean a better motor function

  2. Fugl-Meyer Assessment for Upper Extremity score

    Time frame: 2 weeks after intervention

    range (0-126), higher scores mean a better motor function

Secondary outcomes

  1. Box and Block Test

    Time frame: Baseline

    higher scores mean a worse motor function

  2. Box and Block Test

    Time frame: 2 weeks after intervention

    higher scores mean a worse motor function

  3. Modified Barthel Index

    Time frame: Baseline

    range (0-100), higher scores mean a better activity of daily living

  4. Modified Barthel Index

    Time frame: 2 weeks after intervention

    range (0-100), higher scores mean a better activity of daily living

  5. Motor Activity Log of Amount of Use and Quality of Movement

    Time frame: Baseline

    range (0-150), higher scores mean a better activity of daily living

  6. Motor Activity Log of Amount of Use and Quality of Movement

    Time frame: 2 weeks after intervention

    range (0-150), higher scores mean a better activity of daily living

  7. EuroQol Visual Analogue Scale

    Time frame: Baseline

    range (0-100), higher scores mean a better quality of life

  8. EuroQol Visual Analogue Scale

    Time frame: 2 weeks after intervention

    range (0-100), higher scores mean a better quality of life

  9. Berg Balance Scale

    Time frame: Baseline

    range (0-56), higher scores mean a better balance function

  10. Berg Balance Scale

    Time frame: 2 weeks after intervention

    range (0-56), higher scores mean a better balance function

  11. Grip strength (kg)

    Time frame: Baseline

    higher scores mean a better hand function

  12. Grip strength (kg)

    Time frame: 2 weeks after intervention

    higher scores mean a better hand function

  13. Hand response reaction time

    Time frame: Baseline

    higher scores mean a worse hand function

  14. Hand response reaction time

    Time frame: 2 weeks after intervention

    higher scores mean a worse hand function

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 18, 2022
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.