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

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Other: transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy; Other: transcutaneous vagus nerve stimulation+routine physical therapy

• Registration Number: NCT06632665
• Lead Sponsor: Riphah International University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-05
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Transcutaneous vagus nerve stimulation+Virtual Reality+Routine physical therapy	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 B: Transcutaneous Vagus Nerve Stimulation +Routine physical therapy	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.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA)	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	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	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