Effects Of Transcutaneous Vagus Nerve Stimulation With Virtual Reality In Post-Stroke Patients
Effects of Transcutaneous Vagus Nerve Stimulation With Virtual Reality on Upper Limb Functions in Post-stroke Patients
1 other identifier
interventional
46
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Oct 2024
Shorter than P25 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2024
CompletedFirst Submitted
Initial submission to the registry
October 8, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedOctober 9, 2024
October 1, 2024
10 months
October 8, 2024
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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
4th week
Study Arms (2)
Group A: Transcutaneous vagus nerve stimulation+Virtual Reality+Routine physical therapy
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
Interventions
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 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Muhammad Kashif, PhD-PT
Riphah International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2024
First Posted
October 9, 2024
Study Start
October 5, 2024
Primary Completion
July 30, 2025
Study Completion
July 30, 2025
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share