Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients

NCT05193539 | Completed

• 1 other identifier: 2016-07-012-021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Virtual Reality; Augmented Reality

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment for Upper Extremity score

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

  Baseline

• Fugl-Meyer Assessment for Upper Extremity score

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

  2 weeks after intervention

Secondary Outcomes (14)

• Box and Block Test

  Baseline

• Box and Block Test

  2 weeks after intervention

• Modified Barthel Index

  Baseline

• Modified Barthel Index

  2 weeks after intervention

• Motor Activity Log of Amount of Use and Quality of Movement

  Baseline

Study Arms (2)

Augmented reality and virtual reality rehabilitation

EXPERIMENTAL

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

Conventional occupational therapy

ACTIVE COMPARATOR

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

Behavioral: Conventional occupational therapy

Interventions

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.

Augmented reality and virtual reality rehabilitation

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.

Conventional occupational therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Severe cognitive impairment (defined as score \< 10 on the Mini-Mental State Examination)
• Evidence of apraxia
• Clinical history of neglect
• Previous upper extremity hemiplegia.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD, Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 18, 2022
• Study Start: November 19, 2018
• Primary Completion: December 3, 2018
• Study Completion: October 21, 2019
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

KR (1)