Clinical trial NCT03277950: Effect of Virtual Reality Game on Upper Limb Movement in Individuals With Stroke
Official title: Effect of Game-based Virtual Reality Training on Upper Extremity Movement in Individuals With Subacute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Movement, Abnormal
Keywords: virtual reality
feedback
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 21
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: kinematic data
timeFrame: 10 minutes
Secondary outcomes:
measure: Upper limb performance
timeFrame: 10 minutes
measure: muscle tone
timeFrame: 2 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Vimonwan Hiengkaew, PhD
role: STUDY_CHAIR
affiliation: Mahidol University
name: Peemonkong Wattananon, PhD
role: STUDY_DIRECTOR
affiliation: Mahidol University
name: Sirada Lolak, BSc
role: PRINCIPAL_INVESTIGATOR
References: