Clinical trial NCT06632665: Effects Of Transcutaneous Vagus Nerve Stimulation With Virtual Reality In Post-Stroke Patients
Official title: Effects of Transcutaneous Vagus Nerve Stimulation With Virtual Reality on Upper Limb Functions in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Hand dexterity,Quality of life,Stroke,Transcutaneous vagus nerve stimulation,Upper limb motor function, Virtual reality.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 4th week
measure: Purdue pegboard test
timeFrame: 4th week
measure: Stroke Impact Scale
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif, PhD-PT
role: STUDY_CHAIR
References: