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CompletedNCT05193539Updated Feb 7, 2022

Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

An interventional study of Augmented reality and virtual reality rehabilitation and Conventional occupational therapy in Stroke, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Nov 2018, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Virtual Reality
  • Augmented Reality
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

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.

  • BehavioralConventional 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.

06

What researchers measure

Primary outcomes

  1. Fugl-Meyer Assessment for Upper Extremity score

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

    Time frame: Baseline

  2. Fugl-Meyer Assessment for Upper Extremity score

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

    Time frame: 2 weeks after intervention

Secondary outcomes

  1. Box and Block Test

    higher scores mean a worse motor function

    Time frame: Baseline

  2. Box and Block Test

    higher scores mean a worse motor function

    Time frame: 2 weeks after intervention

  3. Modified Barthel Index

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

    Time frame: Baseline

  4. Modified Barthel Index

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

    Time frame: 2 weeks after intervention

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

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

    Time frame: Baseline

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

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

    Time frame: 2 weeks after intervention

  7. EuroQol Visual Analogue Scale

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

    Time frame: Baseline

  8. EuroQol Visual Analogue Scale

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

    Time frame: 2 weeks after intervention

  9. Berg Balance Scale

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

    Time frame: Baseline

  10. Berg Balance Scale

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

    Time frame: 2 weeks after intervention

  11. Grip strength (kg)

    higher scores mean a better hand function

    Time frame: Baseline

  12. Grip strength (kg)

    higher scores mean a better hand function

    Time frame: 2 weeks after intervention

  13. Hand response reaction time

    higher scores mean a worse hand function

    Time frame: Baseline

  14. Hand response reaction time

    higher scores mean a worse hand function

    Time frame: 2 weeks after intervention

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05193539
Lead sponsor
Samsung Medical Center
Responsible party
Jong Geol Do (M.D, PhD, Assistant professor, Samsung Medical Center) — Principal investigator
First posted
Jan 18, 2022
Start date
Nov 19, 2018
Primary completion
Dec 3, 2018
Completion
Oct 21, 2019
Last update
Feb 7, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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