StrokeNCT04443127
Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients
A study testing Virtual Reality Training Session and Motor-Relearning Program in people with Stroke, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Stroke is the second leading global cause of mortality counting for 6.5 million deaths per annum. The global prevalence of stroke is increasing with an estimated prevalence of 33 million per year, affecting 1 out of 6 individuals during their lifetime. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality Training Session and Motor-Relearning Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2020to 15 Oct 2020
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female stroke patients aged 25-65 years
- Patients who had an ischemic or hemorrhagic stroke in sub-acute phase of < 3 months
- Mild cognitive impairment i.e. < 26 (19.0-25.2) on MoCA
- Minimum Scoring of 28 in the Motricity Index
Who cannot join
- Diagnosed visual-perceptual ailments which may restrict task execution
- Communication disorders such as aphasia or dysarthria which may impede cognitive assessment
- Comorbidities such as elevated blood pressure (>160mmhg/105 mmHg), heart diseases or chronic medical conditions
- Major or active psychological illness and pre-existing dementia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ziauddin University
Karachi, Sindh
Jaza Rizvi, 36629251 ext. 5, jaza.rizvi@zu.edu.pk
About this study
Stroke is the second leading global cause of mortality counting for 6.5 million deaths per annum. The global prevalence of stroke is increasing with an estimated prevalence of 33 million per year, affecting 1 out of 6 individuals during their lifetime. The international data suggests the overall economic burden in Asia is projected to be increased to 1.3 Billion by 2050. Therefore, the appropriate and timely stroke intervention is required to save healthcare costs and reduce the burden of the disease. Studies have reported the effectiveness of VR intervention not only in cognitive abilities but it has found to be simultaneously effective in improving other domains as attention and coordination with motor retraining. VR combined with a newly developed concept of motor priming has shown encouraging results in improving motor control and task execution in stroke patients. Further studies are needed to analyze the impact of motor priming with VR in stroke patients on varied neurological domains; hence the present study aims to investigate the impact of VR based motor priming on sensorimotor, functional and cognitive outcomes among sub-acute stroke patients rehabilitation.
Read the detailed description
A total 62 patients will be recruited in the study. After voluntary consent, all the patients will be randomly divided into Group-A and B through the envelope method of simple random sampling. Patients in Group-A will be receiving VR based motor priming intervention while Group-B patients will be receiving Motor-Relearning Program as conventional therapy. Whereas, both the groups will be given 16 sessions of their respective protocol, comprising of 45 minutes, 4 times/week for the duration of 4 weeks. Pre and post assessment will be performed for each patient on all three quantitative outcome measures i.e. FMA-UE, CAHAI-13, and MoCA. A trial will be terminated, if the patient reported fatigue of >8 out of 10 on the Visual Analogue Scale, unable to execute movements, reports pain, eye strain, or signs of volitional fatigue in hemiplegic or non-hemiplegic extremities.
- Conditions
- Stroke
- Being tested
- Virtual Reality Training Session, Motor-Relearning Program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Training SessionDevice
VR based motor priming intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.
Motor-Relearning ProgramBehavioural
Motor-Relearning Program intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.
| Study group | Role | What they receive |
|---|---|---|
| Game-Based Rehabilitation | Experimental | Not described Receives: Device: Virtual Reality Training Session |
| Conventional Rehabilitation | Placebo comparator | Not described Receives: Behavioral: Motor-Relearning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)
Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
Measured: Baseline
Sensorimotor function of hemiplegic upper extremity (Post-Treatment)
Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
Measured: After 4 weeks
Functional ability of hemiplegic upper extremity (Pre-Treatment)
Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
Measured: Baseline
Functional ability of hemiplegic upper extremity (Post-Treatment)
Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
Measured: After 4 weeks
Cognitive Function (Pre-Treatment)
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
Measured: Baseline
Cognitive Function (Post-Treatment)
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion15 Oct 2020 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaza Rizvi, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443127
- Sponsor's protocol ID
- JRizvi
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT04443127
- Acronym / sponsor ID
- JRizvi
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 23 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.
Stroke is the second leading global cause of mortality counting for 6.5 million deaths per annum. The global prevalence of stroke is increasing with an estimated prevalence of 33 million per year, affecting 1 out of 6 individuals during their lifetime. The international data suggests the overall economic burden in Asia is projected to be increased to 1.3 Billion by 2050. Therefore, the appropriate and timely stroke intervention is required to save healthcare costs and reduce the burden of the disease. Studies have reported the effectiveness of VR intervention not only in cognitive abilities but it has found to be simultaneously effective in improving other domains as attention and coordination with motor retraining. VR combined with a newly developed concept of motor priming has shown encouraging results in improving motor control and task execution in stroke patients. Further studies are needed to analyze the impact of motor priming with VR in stroke patients on varied neurological domains; hence the present study aims to investigate the impact of VR based motor priming on sensorimotor, functional and cognitive outcomes among sub-acute stroke patients rehabilitation.
Detailed description
A total 62 patients will be recruited in the study. After voluntary consent, all the patients will be randomly divided into Group-A and B through the envelope method of simple random sampling. Patients in Group-A will be receiving VR based motor priming intervention while Group-B patients will be receiving Motor-Relearning Program as conventional therapy. Whereas, both the groups will be given 16 sessions of their respective protocol, comprising of 45 minutes, 4 times/week for the duration of 4 weeks. Pre and post assessment will be performed for each patient on all three quantitative outcome measures i.e. FMA-UE, CAHAI-13, and MoCA. A trial will be terminated, if the patient reported fatigue of >8 out of 10 on the Visual Analogue Scale, unable to execute movements, reports pain, eye strain, or signs of volitional fatigue in hemiplegic or non-hemiplegic extremities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game-Based Rehabilitation | Experimental | Device: Virtual Reality Training Session |
| Conventional Rehabilitation | Placebo comparator | Behavioral: Motor-Relearning Program |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female stroke patients aged 25-65 years
- Patients who had an ischemic or hemorrhagic stroke in sub-acute phase of < 3 months
- Mild cognitive impairment i.e. < 26 (19.0-25.2) on MoCA
- Minimum Scoring of 28 in the Motricity Index
Key exclusion criteria (4 listed)
- Diagnosed visual-perceptual ailments which may restrict task execution
- Communication disorders such as aphasia or dysarthria which may impede cognitive assessment
- Comorbidities such as elevated blood pressure (>160mmhg/105 mmHg), heart diseases or chronic medical conditions
- Major or active psychological illness and pre-existing dementia
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 Training SessionVR based motor priming intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments. | Device | Game-Based Rehabilitation |
| Motor-Relearning ProgramMotor-Relearning Program intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments. | Behavioural | Conventional Rehabilitation |
Primary outcome
Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)
Time frame: Baseline
Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
Sensorimotor function of hemiplegic upper extremity (Post-Treatment)
Time frame: After 4 weeks
Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
Functional ability of hemiplegic upper extremity (Pre-Treatment)
Time frame: Baseline
Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
Functional ability of hemiplegic upper extremity (Post-Treatment)
Time frame: After 4 weeks
Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
Cognitive Function (Pre-Treatment)
Time frame: Baseline
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
Cognitive Function (Post-Treatment)
Time frame: After 4 weeks
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Training Session and Motor-Relearning Program in people with Stroke, run by Ziauddin University at 1 site in Pakistan.
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 4 inclusion and 4 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 23 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 Jaza Rizvi (36629251 ext. 5, jaza.rizvi@zu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensorimotor function of hemiplegic upper extremity (Pre-Treatment) (time frame: Baseline). The study lists 6 primary outcomes in all. 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 23 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.