StrokeVRULSNCT03277950
Effect of Virtual Reality Game on Upper Limb Movement in Individuals With Stroke
A study testing Virtual reality with feedback, Virtual reality without feedback and Healthy in people with Stroke and Movement, Abnormal, run by Vimonwan Hiengkaew.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Movement, Abnormal
- What is being tested?
- Virtual reality with feedback, Virtual reality without feedback and Healthy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2017to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with stroke
- 45 - 65 years old
- First ischemic or hemorrhagic stroke
- Right hemiparesis
- Right dominant handedness
- Within 6 months after stroke
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- 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
Who cannot join
- Individual with stroke and healthy
- Have cyber-sickness
- Obesity
- Ataxic movement
- Loss visual field or visual neglect
- Loss exteroceptive sensation
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Virtual reality with feedback, Virtual reality without feedback, Healthy
- Keywords
- virtual reality, feedback
- Medical subject headings
- Stroke, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality with feedbackOther
Individuals with stroke play game with correction of movement.
Virtual reality without feedbackOther
Individuals with stroke play game without correction of movement.
HealthyOther
Healthy do not play game
| Study group | Role | What they receive |
|---|---|---|
| virtual reality with feedback | Experimental | Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks. Receives: Other: Virtual reality with feedback |
| virtual reality without feedback | Active comparator | Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks. Receives: Other: Virtual reality without feedback |
| Healthy | Other | Participants do not play virtual reality game. Receives: Other: Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematic data
angle of shoulder, elbow, and forearm
Measured: 10 minutes
Secondary outcomes (2)
Upper limb performance
doing task according to Fugl Mayer
Measured: 10 minutes
muscle tone
assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start15 Sep 2017 (estimated)
- Primary completion15 Sep 2018 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vimonwan Hiengkaew
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vimonwan Hiengkaew, Mahidol University
- Investigators
- Vimonwan Hiengkaew, PhD, Study chair, Mahidol UniversityPeemonkong Wattananon, PhD, Study director, Mahidol UniversitySirada Lolak, BSc, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277950
- Sponsor's protocol ID
- 2016/097.0906
- Acronym
- VRULS
- Status last verified
- Sep 2017
- First submitted
- 27 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Game-based Virtual Reality Training on Upper Extremity Movement in Individuals With Subacute Stroke
- ClinicalTrials.gov ID
- NCT03277950
- Acronym / sponsor ID
- VRULS / 2016/097.0906
- Conditions
- Stroke, Movement, Abnormal
- Keywords
- virtual reality, feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Vimonwan HiengkaewUniversity, hospital or other
- Study start
- 15 Sep 2017 (estimated)
- Primary completion
- 15 Sep 2018 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| virtual reality with feedback | Experimental | Other: Virtual reality with feedbackParticipants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks. |
| virtual reality without feedback | Active comparator | Other: Virtual reality without feedbackParticipants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks. |
| Healthy | Other | Other: HealthyParticipants do not play virtual reality game. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Individuals with stroke
- 45 - 65 years old
- First ischemic or hemorrhagic stroke
- Right hemiparesis
- Right dominant handedness
Key exclusion criteria (17 listed)
- Individual with stroke and healthy
- Have cyber-sickness
- Obesity
- Ataxic movement
- Loss visual field or visual neglect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality with feedbackIndividuals with stroke play game with correction of movement. | Other | virtual reality with feedback |
| Virtual reality without feedbackIndividuals with stroke play game without correction of movement. | Other | virtual reality without feedback |
| HealthyHealthy do not play game | Other | Healthy |
Primary outcome
kinematic data
Time frame: 10 minutes
angle of shoulder, elbow, and forearm
2 secondary outcomes
Upper limb performance
Time frame: 10 minutes
muscle tone
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vimonwan Hiengkaew, PhD study chair
Mahidol University
Peemonkong Wattananon, PhD study director
Mahidol University
Sirada Lolak, BSc principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality with feedback, Virtual reality without feedback and Healthy in people with Stroke and Movement, Abnormal, run by Vimonwan Hiengkaew.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vimonwan Hiengkaew, PhD (+6624415450, vimonwan.hie@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kinematic data (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017; AzTrials last refreshed its copy on 31 Oct 2026.