Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381089
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-19
Brief Title:
Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients
Sponsor:
SEFA HAKTAN HATIK
Organization:
Sinop University
Study Overview
Official Title:
The Effect of Robotic Rehabilitation and Vagus Nerve Stimulation in Addition to Robotic Rehabilitation on the Patients Functional Level and Autonomic Nervous System in Patients With Ischemic Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERRVNS
Brief Summary:
This study was conducted in patients with ischemic stroke This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patients functional level and autonomic nervous system
40 people over the age of 18 participated in the study They were randomly divided into two groups robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation While the robotic rehabilitation group received Lokomat and neurological rehabilitation the other group received stimulation with the Vagustim device which is applied non-invasively through the ear in addition to Lokomat and neurological rehabilitation Spasticity autonomic nervous system walking speed motor function quality of life muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment In the study significance was evaluated at p005 level
40 people over the age of 18 participated in the study They were randomly divided into two groups robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation While the robotic rehabilitation group received Lokomat and neurological rehabilitation the other group received stimulation with the Vagustim device which is applied non-invasively through the ear in addition to Lokomat and neurological rehabilitation Spasticity autonomic nervous system walking speed motor function quality of life muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment In the study significance was evaluated at p005 level
Detailed Description:
A study group was formed consisting of individuals who had an ischemic stroke over the age of 18 who complied with the research criteria and who signed the voluntary consent form Age gender height weight body mass index dominant side affected side and time since stroke of the participants who met the inclusion criteria were recorded and randomly divided into 2 groups
The groups are They were divided into Robotic Rehabilitation RRG n20 11 women 9 men and Transcutaneous Auricular Vagal Nerve Stimulation VRRG applied in addition to Robotic Rehabilitation n20 9 women 11 men groups
A 6-week protocol was applied in the study In addition to the neurological rehabilitation program robotic rehabilitation was applied to the RRG group 2 days a week In addition to the neurological rehabilitation program both robotic rehabilitation and transcutaneous auricular vagal nerve stimulation were applied to the VRRG group 2 days a week Some evaluations were made by the researcher at two different time periods throughout the study Evaluation times T0 before robotic rehabilitationvagal nerve stimulation application in addition to robotic rehabilitation T1 robotic rehabilitationafter vagal nerve stimulation application applied in addition to robotic rehabilitation These time periods were planned and carried out immediately before the study and after 6 weeks of treatment
The groups are They were divided into Robotic Rehabilitation RRG n20 11 women 9 men and Transcutaneous Auricular Vagal Nerve Stimulation VRRG applied in addition to Robotic Rehabilitation n20 9 women 11 men groups
A 6-week protocol was applied in the study In addition to the neurological rehabilitation program robotic rehabilitation was applied to the RRG group 2 days a week In addition to the neurological rehabilitation program both robotic rehabilitation and transcutaneous auricular vagal nerve stimulation were applied to the VRRG group 2 days a week Some evaluations were made by the researcher at two different time periods throughout the study Evaluation times T0 before robotic rehabilitationvagal nerve stimulation application in addition to robotic rehabilitation T1 robotic rehabilitationafter vagal nerve stimulation application applied in addition to robotic rehabilitation These time periods were planned and carried out immediately before the study and after 6 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None