StrokeNCT06632665
Effects Of Transcutaneous Vagus Nerve Stimulation With Virtual Reality In Post-Stroke Patients
A study testing transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy and transcutaneous vagus nerve stimulation+routine physical therapy in people with Stroke, run by Riphah International University.
Trial summary
Stroke is a neurological condition also known as cerebrovascular accident occurs when blood supply to the brain is disrupted ,either by blockage or rupture of a blood vessels. Upper limb impairment after a stroke denotes diminished function in the arm, hand, wrist, and fingers due to neurological damage. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Stroke
- What is being tested?
- transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy and transcutaneous vagus nerve stimulation+routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2024to 30 Jul 2025
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ischemic stroke at least more than 6 months.
- Patients having Montreal Cognitive Assessment (MoCA) score 26/30
- Patients able to follow and accept verbal instruction
- patients with normal sympathetic acitivity.
Who cannot join
- Patients with history of previous surgical intervention on vagus nerve
- Patients having low heart rate 60 bpm
- Patients with history of any visual and hearing problem
- Patients with history of neuromuscular disorder affecting the function of upper limbs .
- Patients with advance liver,kidney,cardiac ,pulmonary disease
- Patients with history of orthopedic surgery and botulinum toxin injection.
- Patients with increase sympathetic activity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Transcutaneous Vagus Nerve Stimulation With Virtual Reality on Upper Limb Functions in Post-stroke Patients
Stroke is a neurological condition also known as cerebrovascular accident occurs when blood supply to the brain is disrupted ,either by blockage or rupture of a blood vessels. Upper limb impairment after a stroke denotes diminished function in the arm, hand, wrist, and fingers due to neurological damage. Virtual Reality and Trascutaneous vagus nerve stimulation are innovative for post-stroke upper limb rehabilitation VR enhances motor learning and engagement with exercises and feedback, while VNS boosts neuroplasticity and reduces inflammation via vagus nerve stimulation. The aim of the study is to determine the effects of transcutaneous vagus nerve stimulation with virtual reality and routine physiotherapy on upper limb motor function, hand dexterity function and quailty of life .
This randomized clinical trial will be conducted at Al Ehsan Welfare,Lahore .The sample size calculated for this trial will be 50 .The patients will be randomly allocated using online randomization tool into 2 groups. Group A will receive Transcutaneous vagus nerve stimulation with Virtual Reality and Routine physical therapy.Patients will undergo a 60-minute session for four weeks, consisting of 30 minutes of vagus nerve stimulation, 15 minutes of virtual reality training, and 15 minutes of routine physiotherapy for 4 weeks, Group B will receive Transcutaneous Vagus Nerve Stimulation with Routine physical therapy Patients will undergo a 60-minute session for four weeks, which includes 30 minutes of vagus nerve stimulation and 30 minutes of routine physiotherapy per session for 4 weeks.
Purdue pegboard test will be used to assess dexterity function,Fugl - meyer assesment FMA - UE to assess Motor function of upper extremity, Stroke impact scale to measure Quality of life.The assessment will be conducted by assessor at baseline, 2 weeks, 4 weeks, and during a follow-up at 8 weeks after discontinuation of in-clinic therapy.The p value will be set at P= 0.05 to reported any significant difference.Kolmogorov-smirnov test will be used to check the normality of data . For the between group analysis Independent t test will be applied for parametric and Mann Whitney test will be applied for non parametric data. For within group comparison repeated measure ANOVA and Friedman ANOVA will be applied for parametric and non parametric data
- Conditions
- Stroke
- Being tested
- transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy, transcutaneous vagus nerve stimulation+routine physical therapy
- Keywords
- Hand dexterity,Quality of life,Stroke,Transcutaneous vagus nerve stimulation,Upper limb motor function, Virtual reality.
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve stimulation+virtual reality+routine physical therapyOther
Transcutaneous vagus nerve stimulation Location The left auricular branch vagus nerve will be stimulated by the modified dot -like electrodes will be fitted to the cymba conchae.frequency:Stimulation perform for 30 minutes per day for 4 weeks .
duration 600 pulses (intratrain pulse) frequency =20 Hz ; Pulse duration =0.3ms ,lasting 30 seconds each time ,stimulating once every 5 minutes
transcutaneous vagus nerve stimulation+routine physical therapyOther
Transcutaneous vagus nerve stimulation Location The left auricular branch vagus nerve will be stimulated by the modified dot -like electrodes will be fitted to the cymba conchae.Stimulation perform for 30 minutes per day for 4 weeks .
Routine physical therapy Stretching Areas :upper chest ,neck flexors ,shoulder flexor and adductors ,elbow and wrist flexors 10 minute per session,and stretches will held for 10s -30swith four repetition of each.30 minutes per day for 4 weeks Upper extremity Proprioception ,coordination,speed and agility increase such as followReach and grasp Handle turning simulated eating task Inserting object Opening bottle strenghtening exercise Muscles biceps brachii brachialis Coracobrachialis triceps brachii wrist extensors 10 minute per session for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A: Transcutaneous vagus nerve stimulation+Virtual Reality+Routine physical therapy | Experimental | Patients will undergo a 60-minute session for two weeks, consisting of 30 minutes of vagus nerve stimulation, 15 minutes of virtual reality training, and 15 minutes of routine physiotherapy for 4 weeks Receives: Other: transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy |
| Group B: Transcutaneous Vagus Nerve Stimulation +Routine physical therapy | Experimental | Patients will undergo a 60-minute session for two weeks, which includes 30 minutes of vagus nerve stimulation and 30 minutes of routine physiotherapy per session for 4 weeks. Receives: Other: transcutaneous vagus nerve stimulation+routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment is a well established and effective clinical tool designed to assess motor function in individual extensively validated in stroke patients.
Measured: 4th week
Purdue pegboard test
Purdue pegboard test The Purdue Pegboard Test developed by Joseph Tiffin in 1948 ,is widely utilized by clinicians and researchers to assess both gross movementand fingertip dexterity of the arm,hand,and fingers. It consist of a board with 4 cups across the top,containing pegs ,collars,and washers, and two vertical rows of 25 small holes down the center .This test is particularly suitable for evaluating patients with upper extremity impairments caused by neurological or musculoskeletal conditions.
Measured: 4th week
Stroke Impact Scale
The Stroke Impact Scale is a comprehensive assessment tool designed by Duncan et al.specifically for measuring various aspects of health related quality of life in strokes survivors.it consists of 59 items ,each rated on a 5-point likert scale to gauge the level of difficulty experienced by patients.scores are aggregated into different domains ,with a standardized scoring system ranging from 0 to 100 .higher scores reflect a better quality of life across different dimensions impacted by stoke
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start5 Oct 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (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 Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PhD-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632665
- Sponsor's protocol ID
- REC/RCR & AHS/24/0230
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 9 Oct 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Vagus Nerve Stimulation With Virtual Reality on Upper Limb Functions in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT06632665
- Acronym / sponsor ID
- REC/RCR & AHS/24/0230
- Conditions
- Stroke
- Keywords
- Hand dexterity,Quality of life,Stroke,Transcutaneous vagus nerve stimulation,Upper limb motor function, Virtual reality.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Oct 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 9 Oct 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.
Stroke is a neurological condition also known as cerebrovascular accident occurs when blood supply to the brain is disrupted ,either by blockage or rupture of a blood vessels. Upper limb impairment after a stroke denotes diminished function in the arm, hand, wrist, and fingers due to neurological damage. Virtual Reality and Trascutaneous vagus nerve stimulation are innovative for post-stroke upper limb rehabilitation VR enhances motor learning and engagement with exercises and feedback, while VNS boosts neuroplasticity and reduces inflammation via vagus nerve stimulation. The aim of the study is to determine the effects of transcutaneous vagus nerve stimulation with virtual reality and routine physiotherapy on upper limb motor function, hand dexterity function and quailty of life .
This randomized clinical trial will be conducted at Al Ehsan Welfare,Lahore .The sample size calculated for this trial will be 50 .The patients will be randomly allocated using online randomization tool into 2 groups. Group A will receive Transcutaneous vagus nerve stimulation with Virtual Reality and Routine physical therapy.Patients will undergo a 60-minute session for four weeks, consisting of 30 minutes of vagus nerve stimulation, 15 minutes of virtual reality training, and 15 minutes of routine physiotherapy for 4 weeks, Group B will receive Transcutaneous Vagus Nerve Stimulation with Routine physical therapy Patients will undergo a 60-minute session for four weeks, which includes 30 minutes of vagus nerve stimulation and 30 minutes of routine physiotherapy per session for 4 weeks.
Purdue pegboard test will be used to assess dexterity function,Fugl - meyer assesment FMA - UE to assess Motor function of upper extremity, Stroke impact scale to measure Quality of life.The assessment will be conducted by assessor at baseline, 2 weeks, 4 weeks, and during a follow-up at 8 weeks after discontinuation of in-clinic therapy.The p value will be set at P= 0.05 to reported any significant difference.Kolmogorov-smirnov test will be used to check the normality of data . For the between group analysis Independent t test will be applied for parametric and Mann Whitney test will be applied for non parametric data. For within group comparison repeated measure ANOVA and Friedman ANOVA will be applied for parametric and non parametric data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Transcutaneous vagus nerve stimulation+Virtual Reality+Routine physical therapy | Experimental | Other: transcutaneous vagus nerve stimulation+virtual reality+routine physical therapyPatients will undergo a 60-minute session for two weeks, consisting of 30 minutes of vagus nerve stimulation, 15 minutes of virtual reality training, and 15 minutes of routine physiotherapy for 4 weeks |
| Group B: Transcutaneous Vagus Nerve Stimulation +Routine physical therapy | Experimental | Other: transcutaneous vagus nerve stimulation+routine physical therapyPatients will undergo a 60-minute session for two weeks, which includes 30 minutes of vagus nerve stimulation and 30 minutes of routine physiotherapy per session for 4 weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with ischemic stroke at least more than 6 months.
- Patients having Montreal Cognitive Assessment (MoCA) score 26/30
- Patients able to follow and accept verbal instruction
- patients with normal sympathetic acitivity.
Key exclusion criteria (7 listed)
- Patients with history of previous surgical intervention on vagus nerve
- Patients having low heart rate 60 bpm
- Patients with history of any visual and hearing problem
- Patients with history of neuromuscular disorder affecting the function of upper limbs .
- Patients with advance liver,kidney,cardiac ,pulmonary disease
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 |
|---|---|---|
| transcutaneous vagus nerve stimulation+virtual reality+routine physical therapyTranscutaneous vagus nerve stimulation Location The left auricular branch vagus nerve will be stimulated by the modified dot -like electrodes will be fitted to the cymba conchae.frequency:Stimulation perform for 30 minutes per day for 4 weeks . duration 600 pulses (intratrain pulse) frequency =20 Hz ; Pulse duration =0.3ms ,lasting 30 seconds each time ,stimulating once every 5 minutes | Other | Group A: Transcutaneous vagus nerve stimulation+Virtual Reality+Routine physical therapy |
| transcutaneous vagus nerve stimulation+routine physical therapyTranscutaneous vagus nerve stimulation Location The left auricular branch vagus nerve will be stimulated by the modified dot -like electrodes will be fitted to the cymba conchae.Stimulation perform for 30 minutes per day for 4 weeks . Routine physical therapy Stretching Areas :upper chest ,neck flexors ,shoulder flexor and adductors ,elbow and wrist flexors 10 minute per session,and stretches will held for 10s -30swith four repetition of each.30 minutes per day for 4 weeks Upper extremity Proprioception ,coordination,speed and agility increase such as followReach and grasp Handle turning simulated eating task Inserting object Opening bottle strenghtening exercise Muscles biceps brachii brachialis Coracobrachialis triceps brachii wrist extensors 10 minute per session for 4 weeks | Other | Group B: Transcutaneous Vagus Nerve Stimulation +Routine physical therapy |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: 4th week
The Fugl-Meyer Assessment is a well established and effective clinical tool designed to assess motor function in individual extensively validated in stroke patients.
Purdue pegboard test
Time frame: 4th week
Purdue pegboard test The Purdue Pegboard Test developed by Joseph Tiffin in 1948 ,is widely utilized by clinicians and researchers to assess both gross movementand fingertip dexterity of the arm,hand,and fingers. It consist of a board with 4 cups across the top,containing pegs ,collars,and washers, and two vertical rows of 25 small holes down the center .This test is particularly suitable for evaluating patients with upper extremity impairments caused by neurological or musculoskeletal conditions.
Stroke Impact Scale
Time frame: 4th week
The Stroke Impact Scale is a comprehensive assessment tool designed by Duncan et al.specifically for measuring various aspects of health related quality of life in strokes survivors.it consists of 59 items ,each rated on a 5-point likert scale to gauge the level of difficulty experienced by patients.scores are aggregated into different domains ,with a standardized scoring system ranging from 0 to 100 .higher scores reflect a better quality of life across different dimensions impacted by stoke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- 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.
Muhammad Kashif, PhD-PT study chair
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy and transcutaneous vagus nerve stimulation+routine physical therapy in people with Stroke, run by Riphah International 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 4 inclusion and 7 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 9 Oct 2024. 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 Muhammad Kashif, PhD-PT (+923333125303, kashif.shaffi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: 4th week). The study lists 3 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 9 Oct 2024.