Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05342688
Status:
UNKNOWN
Last Update Posted:
2022-04-25
First Post:
2021-11-09
Brief Title:
Contextual Interference Engagement and Change in Motor Performance in Stroke
Sponsor:
University of Haifa
Organization:
University of Haifa
Study Overview
Official Title:
Associations Between Contextual Interference Engagement During Treatment and Change in Motor Performance Among Patients Posts-stroke
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The aim of the study is to examine associations between contextual interference CI engagement during practice and changes in upper limb motor performance among patients post-stroke
Fifty patients over the age of 18 after a stroke in the sub-acute and early chronic stages who have weakness of the upper extremity and are treated in a rehabilitation center will be recruited
The study will include participation in five sessions session 1 for baseline assessment session 2-4 for practice of upper extremity functions and session 5 for post intervention assessment The intervention will include training of three items from the Wolf motor function test in random order high CI group or block order low CI group Outcomes of engagement will include the brain engagement index heart rate variability and galvanic skin response Outcomes of learning will include the pre-post change in performance of the wolf motor function selected items
Fifty patients over the age of 18 after a stroke in the sub-acute and early chronic stages who have weakness of the upper extremity and are treated in a rehabilitation center will be recruited
The study will include participation in five sessions session 1 for baseline assessment session 2-4 for practice of upper extremity functions and session 5 for post intervention assessment The intervention will include training of three items from the Wolf motor function test in random order high CI group or block order low CI group Outcomes of engagement will include the brain engagement index heart rate variability and galvanic skin response Outcomes of learning will include the pre-post change in performance of the wolf motor function selected items
Detailed Description:
The aim of the study is to examine associations between contextual interference CI engagement during practice and changes in upper limb motor performance among patients post-stroke
Fifty patients over the age of 18 after a stroke in the sub-acute and early chronic stages who are treated in a rehabilitation center inpatient or outpatient clinics who have hemiparesis Fugl-Meyer score 11-60 will be recruited
Patients with a history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function pain that prevents active movement hemodynamic instability cognitive decline and language difficulties that do not allow understanding of instructions and cooperation will be excluded
The study will include participation in five sessions In the first session participants will answer a demographic questionnaire and a set of motor including the Wolf motor function test perception and cognitive tests will be delivered Then participants will be assigned to either high or low CI groups In the next three sessions participants will practice three items from the Wolf motor functions test Participants in the high CI group will practice the items in random order and those in the low CI group will practice the selected items in blocked order Assessment of outcomes during practice will include assessment of brain engagement index by recording EEG one electrode and heart rate variability and galvanic skin response In the fifth session at the end of the intervention a reassessment of the wolf motor function performance will be performed
Fifty patients over the age of 18 after a stroke in the sub-acute and early chronic stages who are treated in a rehabilitation center inpatient or outpatient clinics who have hemiparesis Fugl-Meyer score 11-60 will be recruited
Patients with a history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function pain that prevents active movement hemodynamic instability cognitive decline and language difficulties that do not allow understanding of instructions and cooperation will be excluded
The study will include participation in five sessions In the first session participants will answer a demographic questionnaire and a set of motor including the Wolf motor function test perception and cognitive tests will be delivered Then participants will be assigned to either high or low CI groups In the next three sessions participants will practice three items from the Wolf motor functions test Participants in the high CI group will practice the items in random order and those in the low CI group will practice the selected items in blocked order Assessment of outcomes during practice will include assessment of brain engagement index by recording EEG one electrode and heart rate variability and galvanic skin response In the fifth session at the end of the intervention a reassessment of the wolf motor function performance will be performed
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