Chronic StrokeNCT06459531
Effect of VR VS Conservative Treatment 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 18 to 60 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Virtual Reality (VR) Therapy and Conservative Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 1 Nov 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
- Adults aged 18 years and older.
- Demonstrable sensorimotor impairment of the upper extremity due to stroke, as assessed by clinical evaluation.
- Sufficient cognitive ability to follow instructions and participate in VR therapy, as determined by a Mini-Mental State Examination (MMSE) score of 24 or higher.
- Medically stable and able to participate in physical rehabilitation sessions, as cleared by a healthcare professional.
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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
General hospital Jinnah hospital Mayo hospital Chaudhry Muhammad Akram Teaching and research hospital Services hospital Lahore (SHL)
Lahore
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. Studies have indicated that VR can lead to significant improvements in motor function, coordination, and strength of the affected upper limb.
Read the detailed description
These advancements are often attributed to the ability of VR to provide real-time feedback, varied and repetitive tasks, and the stimulation of neuroplasticity. In contrast, conservative treatments, such as traditional physical and occupational therapy, though beneficial, may not offer the same level of stimulation and engagement. Overall, VR therapy can be a valuable adjunct to traditional rehabilitation, potentially accelerating recovery and improving functional outcomes for chronic stroke patients by providing a more dynamic and engaging approach to therapy.
- 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) TherapyBehavioural
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 TreatmentOther
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 |
|---|---|---|
| Virtual Reality (VR) Therapy | Experimental | Not described Receives: Behavioral: Virtual Reality (VR) Therapy |
| Conservative Treatment | Other | Not described Receives: Other: 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.
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.
Scoring:
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.
Usage in the Study:
Assessment Schedule: Administered at baseline and at the end of the intervention period.
Objective: To assess the overall impact of stroke on the patient's quality of life and participation in daily activities
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 posted14 Jun 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion1 Nov 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
- NCT06459531
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/723
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 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 14 Jun 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
- NCT06459531
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/723
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 14 Jun 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. Studies have indicated that VR can lead to significant improvements in motor function, coordination, and strength of the affected upper limb.
Detailed description
These advancements are often attributed to the ability of VR to provide real-time feedback, varied and repetitive tasks, and the stimulation of neuroplasticity. In contrast, conservative treatments, such as traditional physical and occupational therapy, though beneficial, may not offer the same level of stimulation and engagement. Overall, VR therapy can be a valuable adjunct to traditional rehabilitation, potentially accelerating recovery and improving functional outcomes for chronic stroke patients by providing a more dynamic and engaging approach to therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Therapy | Experimental | Behavioral: Virtual Reality (VR) Therapy |
| Conservative Treatment | Other | Other: Conservative Treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
- Adults aged 18 years and older.
- Demonstrable sensorimotor impairment of the upper extremity due to stroke, as assessed by clinical evaluation.
- Sufficient cognitive ability to follow instructions and participate in VR therapy, as determined by a Mini-Mental State Examination (MMSE) score of 24 or higher.
- Medically stable and able to participate in physical rehabilitation sessions, as cleared by a healthcare professional.
Key exclusion criteria (2 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)
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) TherapyPatients 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. | Behavioural | Virtual Reality (VR) Therapy |
| Conservative TreatmentPatients 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. | Other | Conservative Treatment |
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.
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. Scoring: 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. Usage in the Study: Assessment Schedule: Administered at baseline and at the end of the intervention period. Objective: To assess the overall impact of stroke on the patient's quality of life and participation in daily activities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 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 5 inclusion and 2 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 14 Jun 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 14 Jun 2024.