Chronic StrokeNCT06568874
Effect of VR Versus CT in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
A study testing Virtual Reality (VR) Therapy and Conservative Treatment in people with Chronic Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Virtual Reality (VR) Therapy and Conservative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Nov 2023to 30 Oct 2024
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
- Age:
- Upper Extremity Impairment:
- Ability to provide informed consent to participate in the study.
Who cannot join
- Severe communication difficulties that would impede the ability to follow instructions during therapy.
- Severe spasticity in the affected upper limb (Modified Ashworth Scale score of 4 or higher).
- Other Neurological Conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Versus Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises.
- Conditions
- Chronic Stroke
- Being tested
- Virtual Reality (VR) Therapy, Conservative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) TherapyCombination product
Intervention: Patients in this group will receive therapy using VR technology. This involves engaging in various sensorimotor training exercises and tasks in an immersive virtual environment. The VR sessions are designed to be interactive and adaptive, providing real-time feedback to the user. The exercises will target the improvement of motor functions, coordination, and strength of the affected upper extremity.
Duration and Frequency: The specific regimen may involve sessions several times a week, with each session lasting between 30 to 60 minutes, over a period of several weeks or months, depending on the study design.
Conservative TreatmentDiagnostic test
Intervention: Patients in this group will receive traditional rehabilitation therapies, which may include:
Physical Therapy (PT): Exercises and activities aimed at improving strength, flexibility, and coordination of the upper limb.
Occupational Therapy (OT): Functional task training to enhance daily living skills and independence, focusing on the use of the upper extremity.
Manual Therapy: Techniques such as massage or joint manipulation to improve mobility and reduce pain.
Home Exercise Programs: Prescribed exercises to be performed at home to reinforce therapy sessions.
Duration and Frequency: Similar to the VR group, this regimen may involve regular sessions several times a week, with each session lasting between 30 to 60 minutes, over a comparable period.
| Study group | Role | What they receive |
|---|---|---|
| Exp Group | Experimental | Not described Receives: Combination Product: Virtual Reality (VR) Therapy |
| Control Group | Active comparator | Not described Receives: Diagnostic Test: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA) for Upper Extremity
The Fugl-Meyer Assessment (FMA) for Upper Extremity is a widely used and validated tool to evaluate motor function, balance, sensation, and joint functioning in individuals who have had a stroke. It specifically assesses the sensorimotor function of the upper extremities.
Scoring:
The upper extremity section of the FMA includes 33 items, each scored on a scale of 0 to 2:
0: Cannot perform
- Performs partially
- Performs fully The maximum score for the upper extremity section is 66, indicating optimal function.
Measured: 12 Months
Stroke Impact Scale (SIS)
The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates the impact of stroke on multiple dimensions, including strength, hand function, activities of daily living (ADL), mobility, communication, emotion, memory, thinking, and participation.
Each item is scored on a scale of 1 to 5:
1: Unable to do 5: Not difficult at all Higher scores indicate a lesser impact of stroke on the patient's life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start30 Nov 2023
- Primary completion1 Jul 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568874
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/740
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 2024
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Versus Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06568874
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/740
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Aug 2024 (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.
Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exp Group | Experimental | Combination Product: Virtual Reality (VR) Therapy |
| Control Group | Active comparator | Diagnostic Test: Conservative Treatment |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
- Upper Extremity Impairment:
- Ability to provide informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Severe communication difficulties that would impede the ability to follow instructions during therapy.
- Severe spasticity in the affected upper limb (Modified Ashworth Scale score of 4 or higher).
- Other Neurological Conditions
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) TherapyIntervention: Patients in this group will receive therapy using VR technology. This involves engaging in various sensorimotor training exercises and tasks in an immersive virtual environment. The VR sessions are designed to be interactive and adaptive, providing real-time feedback to the user. The exercises will target the improvement of motor functions, coordination, and strength of the affected upper extremity. Duration and Frequency: The specific regimen may involve sessions several times a week, with each session lasting between 30 to 60 minutes, over a period of several weeks or months, depending on the study design. | Combination product | Exp Group |
| Conservative TreatmentIntervention: Patients in this group will receive traditional rehabilitation therapies, which may include: Physical Therapy (PT): Exercises and activities aimed at improving strength, flexibility, and coordination of the upper limb. Occupational Therapy (OT): Functional task training to enhance daily living skills and independence, focusing on the use of the upper extremity. Manual Therapy: Techniques such as massage or joint manipulation to improve mobility and reduce pain. Home Exercise Programs: Prescribed exercises to be performed at home to reinforce therapy sessions. Duration and Frequency: Similar to the VR group, this regimen may involve regular sessions several times a week, with each session lasting between 30 to 60 minutes, over a comparable period. | Diagnostic test | Control Group |
Primary outcome
Fugl-Meyer Assessment (FMA) for Upper Extremity
Time frame: 12 Months
The Fugl-Meyer Assessment (FMA) for Upper Extremity is a widely used and validated tool to evaluate motor function, balance, sensation, and joint functioning in individuals who have had a stroke. It specifically assesses the sensorimotor function of the upper extremities. Scoring: The upper extremity section of the FMA includes 33 items, each scored on a scale of 0 to 2: 0: Cannot perform 1. Performs partially 2. Performs fully The maximum score for the upper extremity section is 66, indicating optimal function.
Stroke Impact Scale (SIS)
Time frame: 12 months
The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates the impact of stroke on multiple dimensions, including strength, hand function, activities of daily living (ADL), mobility, communication, emotion, memory, thinking, and participation. Each item is scored on a scale of 1 to 5: 1: Unable to do 5: Not difficult at all Higher scores indicate a lesser impact of stroke on the patient's life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (VR) Therapy and Conservative Treatment in people with Chronic Stroke, run by Superior 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 3 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 Aug 2024. 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. 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?
Fugl-Meyer Assessment (FMA) for Upper Extremity (time frame: 12 Months). 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 23 Aug 2024.