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

Riphah International University

Status: Not yet enrolling

Conditions: Stroke

Treatments: Other: transcutaneous vagus nerve stimulation+routine physical therapy; Other: transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06632665

REC/RCR &amp AHS/24/0230;

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Other: transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy

Group B: Transcutaneous Vagus Nerve Stimulation +Routine physical therapy

Experimental group

Description:

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.

Treatment:

Other: transcutaneous vagus nerve stimulation+routine physical therapy