Stroke PatientsNCT05178758
Effects of Virtual Reality Training for Stroke Patients
A study testing Virtual Reality (VR) in people with Stroke Patients, run by Sultan Qaboos University.
Trial summary
To examine the effects of using a virtual reality (VR) system to improve upper limb motor function among subacute hemiparetic stroke patients. Under this aim, the investigators have two objectives: (1) to develop and test a procedure for the quantitative assessment of stroke patients in a virtual environment; and (2)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Virtual Reality (VR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 30 Sep 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New in-patients clinically diagnosed hemiparetic stroke patients;
- Patients with a history of the first incidence of stroke with upper limb weakness with a motor impairment upper limbs as a primary deficit;
- muscle strength > 2/5 on the Medical Research Council (MRC) scale;
- good cognitive ability as indicated by a score > 15 on the Mini-Mental State Examination (MMSE); Motricity Index sore > 26; and
- ability to communicate and sign the consent.
Who cannot join
- In-patient with ataxia or any other cerebellar symptoms;
- orthopedic alterations or pain syndrome of the upper limb;
- peripheral nerve damage affecting the upper extremities;
- visual or hearing impairment (does not allow the possibility of interaction with the VR system);
- severe hemispatial neglect;
- severe shoulder or hand pain (unable to volitionally position the hand in the workspace without pain);
Show all 10Show fewer
- insensate forearm and /or hand, edema of the affected forearm and /or hand;
- uncontrolled seizures disorder;
- severe depression (>13 on beck Depression inventory fast screen); and
- severely impaired cognition or comprehension.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Virtual Reality Training on Upper Extremity Motor Recovery for Stroke Patients: A Pilot Study
To examine the effects of using a virtual reality (VR) system to improve upper limb motor function among subacute hemiparetic stroke patients. Under this aim, the investigators have two objectives: (1) to develop and test a procedure for the quantitative assessment of stroke patients in a virtual environment; and (2) to compare the outcome measures of the two groups of stroke patients (VR-intervention vs. conventional-control) on these two modes of training.
Read the detailed description
After being informed about the study and potential risks, all participants who gave written consent will undergo the study. A randomized controlled trial with pre-/post-study, of 42 stroke patients with upper limb weakness (21 patients in the control group and 21 patients in the intervention group), 18-65 years old, all are newly admitted stroke patients in the rehabilitation clinic from one hospital. Participants in the intervention group will receive 60 minutes of VR training to improve upper limb function and daily living activities. Participants in the control group will receive 60 minutes of conventional training to improve upper limb function and daily living activities. The training includes grasp, grip, pinch, gross, and finger-hand coordination movement. The training will perform 5 times/week for 4 weeks. Two outcome measures: (a) The Barthel Index and (b) The Fugl-Meyer Assessment, time spent to complete a task were used to compare two groups.
- Conditions
- Stroke Patients
- Being tested
- Virtual Reality (VR)
- Keywords
- Hemiparetic stroke patients, Virtual reality, Impairment upper limbs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR)Device
Patients in the intervention (VR) group will receive a series of occupational and physical therapy rehabilitation training using the VR system. All training is consists of daily activities oriented by an occupational therapist, including grasp, grip, pinch, gross, and finger-hand coordination movement. Each training will take around 1 hour for one session per day 5 times per week over a maximum of 4 weeks. The training presented a one-on-one that allowed interaction between instructor (or VR system) and participant.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Rehabilitation Training | Experimental | Patients in the VR group will receive VR rehabilitation training in the hospital. The content of the training is the same as the control group. The only difference is that participants in the intervention group will use VR as a training platform. The VR system will include the training materials and tasks required for the patients to perform in the 3D environment. Demographic, clinical data and treatment costs will be collected before and after the rehabilitation training. Receives: Device: Virtual Reality (VR) |
| Control - Conventional Rehabilitation Training | No intervention | Patients in the control group will receive conventional rehabilitation training currently provided in the hospital. An instructor will assign each participant for training. Demographic, clinical data, and treatment costs will be collected before and after completing the rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Barthel Index (BI)
To evaluate upper extremity performance motor function of the stroke patients. It consists of 10 self-care activities, including feeding, Bathing, Bowels, Bladder, Toilet Use, Transfer (bed to chair, and back), Mobility (on level surfaces), stairs, etc. with a total score range from 0 to 100, the higher the score, the more independent on their daily activities; It has good validity (0.82) and reliability (0.83).
Measured: Change from baseline scores on the Barthel index after 4 weeks training
The Fugl-Meyer Assessment (FMA)
To evaluate the upper limb movements, including the functions on the shoulder, elbow, forearm, wrist, and hand functions of the hemiparetic arm. The FMA is measured on 33 tasks with a 3-point ordinal scale (0 to 2), with a total score range from 0 to 66; the higher the score, the more functioning of the upper limb. It has good validity (0.84) and reliability (0.79).
Measured: Change from baseline scores on the Fugl-Meyer Assessment after 4 weeks training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies 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
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moon Fai Chan, PhD, Sultan Qaboos University
- Investigators
- Moon Fai Chan, Principal investigator, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178758
- Sponsor's protocol ID
- MREC #2593
- Status last verified
- May 2022
- First submitted
- 3 Dec 2021
- Last updated
- 4 May 2022
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Training on Upper Extremity Motor Recovery for Stroke Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT05178758
- Acronym / sponsor ID
- MREC #2593
- Conditions
- Stroke Patients
- Keywords
- Hemiparetic stroke patients, Virtual reality, Impairment upper limbs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 5 Jan 2022 (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.
To examine the effects of using a virtual reality (VR) system to improve upper limb motor function among subacute hemiparetic stroke patients. Under this aim, the investigators have two objectives: (1) to develop and test a procedure for the quantitative assessment of stroke patients in a virtual environment; and (2) to compare the outcome measures of the two groups of stroke patients (VR-intervention vs. conventional-control) on these two modes of training.
Detailed description
After being informed about the study and potential risks, all participants who gave written consent will undergo the study. A randomized controlled trial with pre-/post-study, of 42 stroke patients with upper limb weakness (21 patients in the control group and 21 patients in the intervention group), 18-65 years old, all are newly admitted stroke patients in the rehabilitation clinic from one hospital. Participants in the intervention group will receive 60 minutes of VR training to improve upper limb function and daily living activities. Participants in the control group will receive 60 minutes of conventional training to improve upper limb function and daily living activities. The training includes grasp, grip, pinch, gross, and finger-hand coordination movement. The training will perform 5 times/week for 4 weeks. Two outcome measures: (a) The Barthel Index and (b) The Fugl-Meyer Assessment, time spent to complete a task were used to compare two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Rehabilitation Training | Experimental | Device: Virtual Reality (VR)Patients in the VR group will receive VR rehabilitation training in the hospital. The content of the training is the same as the control group. The only difference is that participants in the intervention group will use VR as a training platform. The VR system will include the training materials and tasks required for the patients to perform in the 3D environment. Demographic, clinical data and treatment costs will be collected before and after the rehabilitation training. |
| Control - Conventional Rehabilitation Training | No intervention | –Patients in the control group will receive conventional rehabilitation training currently provided in the hospital. An instructor will assign each participant for training. Demographic, clinical data, and treatment costs will be collected before and after completing the rehabilitation training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New in-patients clinically diagnosed hemiparetic stroke patients;
- Patients with a history of the first incidence of stroke with upper limb weakness with a motor impairment upper limbs as a primary deficit;
- muscle strength > 2/5 on the Medical Research Council (MRC) scale;
- good cognitive ability as indicated by a score > 15 on the Mini-Mental State Examination (MMSE); Motricity Index sore > 26; and
- ability to communicate and sign the consent.
Key exclusion criteria (10 listed)
- In-patient with ataxia or any other cerebellar symptoms;
- orthopedic alterations or pain syndrome of the upper limb;
- peripheral nerve damage affecting the upper extremities;
- visual or hearing impairment (does not allow the possibility of interaction with the VR system);
- severe hemispatial 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 (VR)Patients in the intervention (VR) group will receive a series of occupational and physical therapy rehabilitation training using the VR system. All training is consists of daily activities oriented by an occupational therapist, including grasp, grip, pinch, gross, and finger-hand coordination movement. Each training will take around 1 hour for one session per day 5 times per week over a maximum of 4 weeks. The training presented a one-on-one that allowed interaction between instructor (or VR system) and participant. | Device | Virtual Reality (VR) Rehabilitation Training |
Primary outcome
The Barthel Index (BI)
Time frame: Change from baseline scores on the Barthel index after 4 weeks training
To evaluate upper extremity performance motor function of the stroke patients. It consists of 10 self-care activities, including feeding, Bathing, Bowels, Bladder, Toilet Use, Transfer (bed to chair, and back), Mobility (on level surfaces), stairs, etc. with a total score range from 0 to 100, the higher the score, the more independent on their daily activities; It has good validity (0.82) and reliability (0.83).
The Fugl-Meyer Assessment (FMA)
Time frame: Change from baseline scores on the Fugl-Meyer Assessment after 4 weeks training
To evaluate the upper limb movements, including the functions on the shoulder, elbow, forearm, wrist, and hand functions of the hemiparetic arm. The FMA is measured on 33 tasks with a 3-point ordinal scale (0 to 2), with a total score range from 0 to 66; the higher the score, the more functioning of the upper limb. It has good validity (0.84) and reliability (0.79).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke Patients
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: the MAGRITTE Study.
Stroke
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
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.
Moon Fai Chan principal investigator
Sultan Qaboos University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) in people with Stroke Patients, run by Sultan Qaboos University.
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 5 inclusion and 10 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 4 May 2022. 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 Moon Fai Chan (+968 24141132, moonf@squ.edu.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Barthel Index (BI) (time frame: Change from baseline scores on the Barthel index after 4 weeks training). The study lists 2 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 4 May 2022.