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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03277950
Other study ID # 2016/097.0906
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 27, 2017
Last updated September 8, 2017
Start date September 15, 2017
Est. completion date September 15, 2019

Study information

Verified date September 2017
Source Mahidol University
Contact Vimonwan Hiengkaew, PhD
Phone +6624415450
Email vimonwan.hie@mahidol.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 21
Est. completion date September 15, 2019
Est. primary completion date September 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual reality with feedback
Individuals with stroke play game with correction of movement.
Virtual reality without feedback
Individuals with stroke play game without correction of movement.
Healthy
Healthy do not play game

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vimonwan Hiengkaew

Outcome

Type Measure Description Time frame Safety issue
Primary kinematic data angle of shoulder, elbow, and forearm 10 minutes
Secondary Upper limb performance doing task according to Fugl Mayer 10 minutes
Secondary muscle tone assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale 2 minutes
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