Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05193539
Collaborator
(none)
30
1
2
11
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Augmented reality and virtual reality rehabilitation
  • Behavioral: Conventional occupational therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
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.
Primary Purpose:
Treatment
Official Title:
Effects of Comprehensive Augmented and Virtual Reality for Upper Limb Rehabilitation in First-Ever Stroke Patients
Actual Study Start Date :
Nov 19, 2018
Actual Primary Completion Date :
Dec 3, 2018
Actual Study Completion Date :
Oct 21, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment for Upper Extremity score [Baseline]

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

  2. Fugl-Meyer Assessment for Upper Extremity score [2 weeks after intervention]

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

Secondary Outcome Measures

  1. Box and Block Test [Baseline]

    higher scores mean a worse motor function

  2. Box and Block Test [2 weeks after intervention]

    higher scores mean a worse motor function

  3. Modified Barthel Index [Baseline]

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

  4. Modified Barthel Index [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 [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 [2 weeks after intervention]

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

  7. EuroQol Visual Analogue Scale [Baseline]

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

  8. EuroQol Visual Analogue Scale [2 weeks after intervention]

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

  9. Berg Balance Scale [Baseline]

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

  10. Berg Balance Scale [2 weeks after intervention]

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

  11. Grip strength (kg) [Baseline]

    higher scores mean a better hand function

  12. Grip strength (kg) [2 weeks after intervention]

    higher scores mean a better hand function

  13. Hand response reaction time [Baseline]

    higher scores mean a worse hand function

  14. Hand response reaction time [2 weeks after intervention]

    higher scores mean a worse hand function

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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:
  • Severe cognitive impairment (defined as score < 10 on the Mini-Mental State Examination)

  • Evidence of apraxia

  • Clinical history of neglect

  • Previous upper extremity hemiplegia.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jong Geol Do, M.D, PhD, Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT05193539
Other Study ID Numbers:
  • 2016-07-012-021
First Posted:
Jan 18, 2022
Last Update Posted:
Feb 7, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jong Geol Do, M.D, PhD, Assistant professor, Samsung Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 7, 2022