StrokeNCT04441177

Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation

A study testing PlayStation®VR training in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Compared to conventional rehabilitation therapy, the full-immersive commercial game (CG) system, in the form of available video game, could safely provide more positive effect on health-related quality of life (HRQOL) and motor function in post-stroke patients. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Stroke
What is being tested?: PlayStation®VR training
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteTaiwan
Study dates: 29 Jul 2019to 30 Jun 2021
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

first-time unilateral cerebral stroke
stroke onset less or equal to 1 year
admission to the rehabilitation ward
ages 20-80 years
spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale
no active medical problems such as fever, pneumonia, or scabies

Who cannot join

brainstem or cerebellar stroke
epilepsy history, including photosensitive epilepsy
previous or active heart diseases, such as myocardial infarction or angina
visuospatial problems related to stroke, such as hemianopia or hemineglect
paretic upper limb reaches Brunnstrom recovery stage VI
severe aphasia
severe cognitive impairment
poor cooperation with assessments

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chiayi Chang Gung Memorial Hospital
Pozi, 613

Other trials in Taiwan

About this study

Official title: Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study

The study aims to perform the research from 2019/7/1 to 2021/6/30 and enrolls a total of 80 participants. Stroke participants are recruited from the rehabilitation ward of CGMH hospital.

The inclusion criteria are (a) first-time unilateral cerebral stroke, (b) stroke onset less or equal to 1 year, (c) admission to the rehabilitation ward, (d) ages 20-80 years, (e) spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale, and (f) no active medical problems such as fever, pneumonia, or scabies. The exclusion criteria are (a) brainstem or cerebellar stroke, (b) epilepsy history, including photosensitive epilepsy, (c) previous or active heart diseases, such as myocardial infarction or angina, (d) visuospatial problems related to stroke, such as hemianopia or hemineglect, (e) paretic upper limb reaches Brunnstrom recovery stage VI, (f) severe aphasia, (g) severe cognitive impairment, and (h) poor cooperation with assessments.

All participants are randomly allocated to study group and control group. Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period. Pre-intervention, post-intervention, and 3-month follow-up HRQOL will be assessed by the Stroke Impact Scale 3.0. Motricity Index and Fugl-Meyer Assessment, Functional Independence Measure, and arm movement ratio will also be checked before intervention, after intervention, and at 3-month follow-up. The safety outcome, intervention-related adverse events or any serious adverse events, during study period will be recorded.

Conditions: Stroke
Being tested: PlayStation®VR training
Keywords: Stroke, Virtual Reality, Rehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlayStation®VR trainingDevice
Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.

Study groups in NCT04441177
Study group	Role	What they receive
Study group	Experimental	Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period. Receives: Device: PlayStation®VR training
Control group	No intervention	Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.

What is being measured

The primary outcome is the main question the study is designed to answer.

Stroke Impact Scale (SIS) 3.0 Questionnaire
Health-Related Quality of Life
Measured: Baseline (Pre-intervention at 2 days after enrollment)
Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
Post-intervention Health-Related Quality of Life
Measured: Change from baseline SIS scores at 18 days after enrollment
3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
3-month follow-up Health-Related Quality of Life
Measured: Change from baseline SIS scores at 92 days after enrollment
Post-Intervention of Adverse Events or SAE
Proportion of intervention-related adverse events or SAE
Measured: 16 days

Secondary outcomes (12)

Motricity Index (MI) Upper Extremity Test
Motor impairment and function
Measured: Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Motricity Index (MI) Upper Extremity Test
Post-intervention motor impairment and function
Measured: Change from baseline MI scores at 18 days after enrollment
3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test
3-month follow-up motor impairment and function
Measured: Change from baseline MI scores at 92 days after enrollment
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Motor impairment and function
Measured: Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Post-intervention motor impairment and function
Measured: Change from baseline FMA-UE scores at 18 days after enrollment
3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
3-month follow-up motor impairment and function
Measured: Change from baseline FMA-UE scores at 92 days after enrollment
Self-Care in Functional Independence Measure (FIM) Instrument
The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
Measured: Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument
The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
Measured: Change from baseline self-care scores at 18 days after enrollment
3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument
The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
Measured: Change from baseline self-care scores at 92 days after enrollment
Arm Movement Ratio (AMR) Test
The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
Measured: Baseline (Pre-intervention) at 1 day after enrollment
Post-Intervention Change of Arm Movement Ratio (AMR) Test
The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
Measured: Change from baseline AMR scores at 19 days after enrollment
3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test
The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
Measured: Change from baseline AMR scores at 93 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 201930 Jun 2021

First posted22 Jun 2020
Study start29 Jul 2019
Primary completion30 Jun 2021 (estimated)
Study completion30 Jun 2021 (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.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
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
Model description: All participants are randomly allocated to study group and control group. Each participant's main study period is set as 16 days with additional follow-up time at post-intervention 3 months. Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04441177
Sponsor's protocol ID: 201801607A3
Status last verified: Jun 2020
First submitted: 16 Jun 2020
Last updated: 22 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study
ClinicalTrials.gov ID: NCT04441177
Acronym / sponsor ID: 201801607A3
Conditions: Stroke
Keywords: Stroke, Virtual Reality, Rehabilitation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 29 Jul 2019 (actual)
Primary completion: 30 Jun 2021 (estimated)
Study completion: 30 Jun 2021 (estimated)
First posted: 22 Jun 2020 (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.

The study aims to perform the research from 2019/7/1 to 2021/6/30 and enrolls a total of 80 participants. Stroke participants are recruited from the rehabilitation ward of CGMH hospital.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: All participants are randomly allocated to study group and control group. Each participant's main study period is set as 16 days with additional follow-up time at post-intervention 3 months. Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.

Arm	Type	Receives
Study group	Experimental	Device: PlayStation®VR trainingParticipants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.
Control group	No intervention	–Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

first-time unilateral cerebral stroke
stroke onset less or equal to 1 year
admission to the rehabilitation ward
ages 20-80 years
spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale

Key exclusion criteria (8 listed)

brainstem or cerebellar stroke
epilepsy history, including photosensitive epilepsy
previous or active heart diseases, such as myocardial infarction or angina
visuospatial problems related to stroke, such as hemianopia or hemineglect
paretic upper limb reaches Brunnstrom recovery stage VI

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
PlayStation®VR trainingParticipants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.	Device	Study group

Primary outcome

Stroke Impact Scale (SIS) 3.0 Questionnaire
Time frame: Baseline (Pre-intervention at 2 days after enrollment)
Health-Related Quality of Life
Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
Time frame: Change from baseline SIS scores at 18 days after enrollment
Post-intervention Health-Related Quality of Life
3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
Time frame: Change from baseline SIS scores at 92 days after enrollment
3-month follow-up Health-Related Quality of Life
Post-Intervention of Adverse Events or SAE
Time frame: 16 days
Proportion of intervention-related adverse events or SAE

12 secondary outcomes

Motricity Index (MI) Upper Extremity Test
Time frame: Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Motricity Index (MI) Upper Extremity Test
Time frame: Change from baseline MI scores at 18 days after enrollment
3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test
Time frame: Change from baseline MI scores at 92 days after enrollment
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Change from baseline FMA-UE scores at 18 days after enrollment
3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Change from baseline FMA-UE scores at 92 days after enrollment
Self-Care in Functional Independence Measure (FIM) Instrument
Time frame: Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument
Time frame: Change from baseline self-care scores at 18 days after enrollment
3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument
Time frame: Change from baseline self-care scores at 92 days after enrollment
Arm Movement Ratio (AMR) Test
Time frame: Baseline (Pre-intervention) at 1 day after enrollment
Post-Intervention Change of Arm Movement Ratio (AMR) Test
Time frame: Change from baseline AMR scores at 19 days after enrollment
3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test
Time frame: Change from baseline AMR scores at 93 days after enrollment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

Chien-Min Chen, MD principal investigator

Chang Gung Memorial Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PlayStation®VR training in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 6 inclusion and 8 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke Impact Scale (SIS) 3.0 Questionnaire (time frame: Baseline (Pre-intervention at 2 days after enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04441177.

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 22 Jun 2020.