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

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: Unknown
• Conditions: Stroke; Movement, Abnormal
• Intervention / Treatment: Other: Virtual reality with feedback; Other: Virtual reality without feedback; Other: Healthy

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: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
kinematic data	angle of shoulder, elbow, and forearm	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb performance	doing task according to Fugl Mayer	10 minutes
muscle tone	assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale	2 minutes

Collaborators and Investigators

• Sponsor: Vimonwan Hiengkaew
• Investigators: Study Chair: Vimonwan Hiengkaew, PhD, Mahidol University; Study Director: Peemonkong Wattananon, PhD, Mahidol University; Principal Investigator: Sirada Lolak, BSc, Mahidol University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 15, 2017
• Primary Completion (ANTICIPATED): September 15, 2018
• Study Completion (ANTICIPATED): September 15, 2019

Study Registration Dates

• First Submitted: August 27, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (ACTUAL): September 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: feedback; virtual reality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Stroke; Dyskinesias
• Other Study ID 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