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Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Augmented reality and virtual reality rehabilitation
Conventional occupational therapy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual Reality, Augmented Reality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Augmented reality and virtual reality rehabilitation

Conventional occupational therapy

Arm Description

This group underwent augmented reality and virtual reality rehabilitation for 60 minutes per session, 5 days per week for 2 weeks.

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

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment for Upper Extremity score
range (0-126), higher scores mean a better motor function
Fugl-Meyer Assessment for Upper Extremity score
range (0-126), higher scores mean a better motor function

Secondary Outcome Measures

Box and Block Test
higher scores mean a worse motor function
Box and Block Test
higher scores mean a worse motor function
Modified Barthel Index
range (0-100), higher scores mean a better activity of daily living
Modified Barthel Index
range (0-100), higher scores mean a better activity of daily living
Motor Activity Log of Amount of Use and Quality of Movement
range (0-150), higher scores mean a better activity of daily living
Motor Activity Log of Amount of Use and Quality of Movement
range (0-150), higher scores mean a better activity of daily living
EuroQol Visual Analogue Scale
range (0-100), higher scores mean a better quality of life
EuroQol Visual Analogue Scale
range (0-100), higher scores mean a better quality of life
Berg Balance Scale
range (0-56), higher scores mean a better balance function
Berg Balance Scale
range (0-56), higher scores mean a better balance function
Grip strength (kg)
higher scores mean a better hand function
Grip strength (kg)
higher scores mean a better hand function
Hand response reaction time
higher scores mean a worse hand function
Hand response reaction time
higher scores mean a worse hand function

Full Information

First Posted
December 9, 2021
Last Updated
January 23, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05193539
Brief Title
Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients
Official Title
Effects of Comprehensive Augmented and Virtual Reality for Upper Limb Rehabilitation in First-Ever Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 3, 2018 (Actual)
Study Completion Date
October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual Reality, Augmented Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Augmented reality and virtual reality rehabilitation
Arm Type
Experimental
Arm Description
This group underwent augmented reality and virtual reality rehabilitation for 60 minutes per session, 5 days per week for 2 weeks.
Arm Title
Conventional occupational therapy
Arm Type
Active Comparator
Arm Description
This group underwent conventional occutational therapy for 60 minutes per session, 5 days per week for 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Augmented reality and virtual reality rehabilitation
Intervention Description
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
Intervention Name(s)
Conventional occupational therapy
Intervention Description
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 Outcome Measure Information:
Title
Fugl-Meyer Assessment for Upper Extremity score
Description
range (0-126), higher scores mean a better motor function
Time Frame
Baseline
Title
Fugl-Meyer Assessment for Upper Extremity score
Description
range (0-126), higher scores mean a better motor function
Time Frame
2 weeks after intervention
Secondary Outcome Measure Information:
Title
Box and Block Test
Description
higher scores mean a worse motor function
Time Frame
Baseline
Title
Box and Block Test
Description
higher scores mean a worse motor function
Time Frame
2 weeks after intervention
Title
Modified Barthel Index
Description
range (0-100), higher scores mean a better activity of daily living
Time Frame
Baseline
Title
Modified Barthel Index
Description
range (0-100), higher scores mean a better activity of daily living
Time Frame
2 weeks after intervention
Title
Motor Activity Log of Amount of Use and Quality of Movement
Description
range (0-150), higher scores mean a better activity of daily living
Time Frame
Baseline
Title
Motor Activity Log of Amount of Use and Quality of Movement
Description
range (0-150), higher scores mean a better activity of daily living
Time Frame
2 weeks after intervention
Title
EuroQol Visual Analogue Scale
Description
range (0-100), higher scores mean a better quality of life
Time Frame
Baseline
Title
EuroQol Visual Analogue Scale
Description
range (0-100), higher scores mean a better quality of life
Time Frame
2 weeks after intervention
Title
Berg Balance Scale
Description
range (0-56), higher scores mean a better balance function
Time Frame
Baseline
Title
Berg Balance Scale
Description
range (0-56), higher scores mean a better balance function
Time Frame
2 weeks after intervention
Title
Grip strength (kg)
Description
higher scores mean a better hand function
Time Frame
Baseline
Title
Grip strength (kg)
Description
higher scores mean a better hand function
Time Frame
2 weeks after intervention
Title
Hand response reaction time
Description
higher scores mean a worse hand function
Time Frame
Baseline
Title
Hand response reaction time
Description
higher scores mean a worse hand function
Time Frame
2 weeks after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

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