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

Primary Purpose

Stroke, Movement, Abnormal

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Virtual reality with feedback

Virtual reality without feedback

Healthy

About this trial

This is an interventional treatment trial for Stroke focused on measuring virtual reality, feedback

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Individuals with stroke

45 - 65 years old
First ischemic or hemorrhagic stroke
Right hemiparesis
Right dominant handedness
Within 6 months after stroke
Discharge from hospital and stay at home
Normal dynamic sitting balance
At least 120 degrees of shoulder flexion and 45 degrees of shoulder extension by passive range of motion
Active movement at least stage 3 by Chedoke-McMaster Stroke Assessment
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
No cognitive impairment

Healthy individuals

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

Exclusion Criteria:

Individual with stroke and healthy

Have cyber-sickness
Obesity
Ataxic movement
Loss visual field or visual neglect
Loss exteroceptive sensation
Impaired or loss proprioceptive sensation
Receive the occupation therapy on upper extremity
Muscle contracture at the scapula, shoulder and elbow
Pain at the scapula, shoulder and elbow
History of fracture or surgery at head, shoulder, scapula, and elbow
Shoulder subluxation
Other neurological disorders
Uncontrolled hypertension
Myocardial infarction
Seizure or epilepsy
Pacemaker or hemodialysis vascular access

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

virtual reality with feedback

virtual reality without feedback

Healthy

Arm Description

Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.

Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.

Participants do not play virtual reality game.

Outcomes

Primary Outcome Measures

kinematic data

angle of shoulder, elbow, and forearm

Secondary Outcome Measures

Upper limb performance

doing task according to Fugl Mayer

muscle tone

assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale

Full Information

NCT ID

NCT03277950

First Posted

August 27, 2017

Last Updated

September 8, 2017

Sponsor

Vimonwan Hiengkaew

1. Study Identification

Unique Protocol Identification Number

NCT03277950

Brief Title

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

Acronym

VRULS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2017 (Anticipated)

Primary Completion Date

September 15, 2018 (Anticipated)

Study Completion Date

September 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Vimonwan Hiengkaew

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Movement, Abnormal

Keywords

virtual reality, feedback

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

virtual reality with feedback

Arm Type

Experimental

Arm Description

Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.

Arm Title

virtual reality without feedback

Arm Type

Active Comparator

Arm Description

Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.

Arm Title

Healthy

Arm Type

Other

Arm Description

Participants do not play virtual reality game.

Intervention Type

Other

Intervention Name(s)

Virtual reality with feedback

Intervention Description

Individuals with stroke play game with correction of movement.

Intervention Type

Other

Intervention Name(s)

Virtual reality without feedback

Intervention Description

Individuals with stroke play game without correction of movement.

Intervention Type

Other

Intervention Name(s)

Healthy

Intervention Description

Healthy do not play game

Primary Outcome Measure Information:

Title

kinematic data

Description

angle of shoulder, elbow, and forearm

Time Frame

10 minutes

Secondary Outcome Measure Information:

Title

Upper limb performance

Description

doing task according to Fugl Mayer

Time Frame

10 minutes

Title

muscle tone

Description

assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale

Time Frame

2 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals with stroke 45 - 65 years old First ischemic or hemorrhagic stroke Right hemiparesis Right dominant handedness Within 6 months after stroke Discharge from hospital and stay at home Normal dynamic sitting balance At least 120 degrees of shoulder flexion and 45 degrees of shoulder extension by passive range of motion Active movement at least stage 3 by Chedoke-McMaster Stroke Assessment 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 No cognitive impairment Healthy individuals Have same gender and age within range of ±5 years of individuals with stroke Right handedness Active range of motion of shoulder flexion and extension at least 120°and 45° respectively No cognitive impairment Exclusion Criteria: Individual with stroke and healthy Have cyber-sickness Obesity Ataxic movement Loss visual field or visual neglect Loss exteroceptive sensation Impaired or loss proprioceptive sensation Receive the occupation therapy on upper extremity Muscle contracture at the scapula, shoulder and elbow Pain at the scapula, shoulder and elbow History of fracture or surgery at head, shoulder, scapula, and elbow Shoulder subluxation Other neurological disorders Uncontrolled hypertension Myocardial infarction Seizure or epilepsy Pacemaker or hemodialysis vascular access

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vimonwan Hiengkaew, PhD

Phone

+6624415450

vimonwan.hie@mahidol.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vimonwan Hiengkaew, PhD

Organizational Affiliation

Mahidol University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Peemonkong Wattananon, PhD

Organizational Affiliation

Mahidol University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sirada Lolak, BSc

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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

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