Effects Of Transcutaneous Vagus Nerve Stimulation With Virtual Reality In Post-Stroke Patients

NCT ID: NCT06632665

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-05
• Study Completion Date: 2025-07-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A: Transcutaneous vagus nerve stimulation+Virtual Reality+Routine physical therapy

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

Group Type: EXPERIMENTAL

transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy

Intervention Type: OTHER

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

Group B: Transcutaneous Vagus Nerve Stimulation +Routine physical therapy

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.

Group Type: EXPERIMENTAL

transcutaneous vagus nerve stimulation+routine physical therapy

Intervention Type: OTHER

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

Interventions

transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy

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

Intervention Type: OTHER

transcutaneous vagus nerve stimulation+routine physical therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Kashif, PhD-PT

Role: STUDY_CHAIR

Riphah International University

Central Contacts

Muhammad Kashif, PhD-PT

Role: CONTACT

kashif.shaffi@gmail.com

+923333125303

Adeela Ayub, DPT

Role: CONTACT

adeelamalik0914@gmail.com

03314196940

Other Identifiers

REC/RCR & AHS/24/0230

Identifier Type: -

Identifier Source: org_study_id