Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632665
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Effects Of Transcutaneous Vagus Nerve Stimulation With Virtual Reality In Post-Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Transcutaneous Vagus Nerve Stimulation With Virtual Reality on Upper Limb Functions in Post-stroke Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 WelfareLahore 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 therapyPatients 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 functionFugl - meyer assesment FMA - UE to assess Motor function of upper extremity Stroke impact scale to measure Quality of lifeThe 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 therapyThe p value will be set at P 005 to reported any significant differenceKolmogorov-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
This randomized clinical trial will be conducted at Al Ehsan WelfareLahore 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 therapyPatients 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 functionFugl - meyer assesment FMA - UE to assess Motor function of upper extremity Stroke impact scale to measure Quality of lifeThe 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 therapyThe p value will be set at P 005 to reported any significant differenceKolmogorov-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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None