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

NCT ID: NCT03277950

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-09-15

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.

Conditions

Stroke; Movement, Abnormal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual reality with feedback

Intervention Type: OTHER

Individuals with stroke play game with correction of movement.

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.

Group Type: ACTIVE_COMPARATOR

Virtual reality without feedback

Intervention Type: OTHER

Individuals with stroke play game without correction of movement.

Healthy

Participants do not play virtual reality game.

Group Type: OTHER

Healthy

Intervention Type: OTHER

Healthy do not play game

Interventions

Virtual reality with feedback

Individuals with stroke play game with correction of movement.

Intervention Type: OTHER

Virtual reality without feedback

Individuals with stroke play game without correction of movement.

Intervention Type: OTHER

Healthy

Healthy do not play game

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vimonwan Hiengkaew

OTHER

Sponsor Role: lead

Responsible Party

Vimonwan Hiengkaew

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vimonwan Hiengkaew, PhD

Role: STUDY_CHAIR

Mahidol University

Peemonkong Wattananon, PhD

Role: STUDY_DIRECTOR

Mahidol University

Sirada Lolak, BSc

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Central Contacts

Vimonwan Hiengkaew, PhD

Role: CONTACT

vimonwan.hie@mahidol.ac.th

+6624415450

Other Identifiers

2016/097.0906

Identifier Type: -

Identifier Source: org_study_id