Effect of Virtual Reality Game on Upper Limb Movement in Individuals With Stroke (VRULS)

September 8, 2017 updated by: Vimonwan Hiengkaew

Effect of Game-based Virtual Reality Training on Upper Extremity Movement in Individuals With Subacute Stroke

Individuals with stroke show abnormal movement pattern of upper limb. The movement pattern needs to be corrected. There are several methods to train normal movement. Exercise with technology is an active movement and affects sensory and cognitive systems. It may benefit to individuals with stroke in training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Individuals with stroke sign informed consent. They are trained with virtual reality game with and without feedback from a researcher. Age-matched healthy play the same game as individuals with stroke do. Both individuals with stroke and healthy are measured upper limb movement pattern.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Individuals with stroke

  1. 45 - 65 years old
  2. First ischemic or hemorrhagic stroke
  3. Right hemiparesis
  4. Right dominant handedness
  5. Within 6 months after stroke
  6. Discharge from hospital and stay at home
  7. Normal dynamic sitting balance
  8. At least 120 degrees of shoulder flexion and 45 degrees of shoulder extension by passive range of motion
  9. Active movement at least stage 3 by Chedoke-McMaster Stroke Assessment
  10. Muscle tone graded 1-2 by Modified Ashworth Scale in 2 of 3 muscle groups including shoulder adductor, internal rotator or/and elbow flexor groups
  11. No cognitive impairment

Healthy individuals

  1. Have same gender and age within range of ±5 years of individuals with stroke
  2. Right handedness
  3. Active range of motion of shoulder flexion and extension at least 120°and 45° respectively
  4. No cognitive impairment

Exclusion Criteria:

Individual with stroke and healthy

  1. Have cyber-sickness
  2. Obesity
  3. Ataxic movement
  4. Loss visual field or visual neglect
  5. Loss exteroceptive sensation
  6. Impaired or loss proprioceptive sensation
  7. Receive the occupation therapy on upper extremity
  8. Muscle contracture at the scapula, shoulder and elbow
  9. Pain at the scapula, shoulder and elbow
  10. History of fracture or surgery at head, shoulder, scapula, and elbow
  11. Shoulder subluxation
  12. Other neurological disorders
  13. Uncontrolled hypertension
  14. Myocardial infarction
  15. Seizure or epilepsy
  16. Pacemaker or hemodialysis vascular access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: virtual reality with feedback
Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.
Other: Virtual reality with feedback
Individuals with stroke play game with correction of movement.
ACTIVE_COMPARATOR: virtual reality without feedback
Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.
Other: Virtual reality without feedback
Individuals with stroke play game without correction of movement.
OTHER: Healthy
Participants do not play virtual reality game.
Other: Healthy
Healthy do not play game

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
kinematic data
Time Frame: 10 minutes
angle of shoulder, elbow, and forearm
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Upper limb performance
Time Frame: 10 minutes
doing task according to Fugl Mayer
10 minutes
muscle tone
Time Frame: 2 minutes
assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vimonwan Hiengkaew

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Vimonwan Hiengkaew, PhD, Mahidol University
  • Study Director: Peemonkong Wattananon, PhD, Mahidol University
  • Principal Investigator: Sirada Lolak, BSc, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/097.0906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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