Contextual Interference, Engagement , and Change in Motor Performance in Stroke
NCT ID: NCT05342688
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2020-01-01
2023-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High contextual interference
The intervention will involve practicing three items from the Wolf motor function test in random order during three sessions. Each item will be repeated 30 times in total.
Task-specific practice of upper extremity functions
The intervention will consist of training of items from the Wolf motor function test.
Low contextual interference
The intervention will involve practicing three items from the Wolf motor function test in blocked order during three sessions. Each item will be repeated 30 times in total.
Task-specific practice of upper extremity functions
The intervention will consist of training of items from the Wolf motor function test.
Interventions
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Task-specific practice of upper extremity functions
The intervention will consist of training of items from the Wolf motor function test.
Eligibility Criteria
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Inclusion Criteria
* Score of 11-60 on the Fugl-Meyer Assessment for upper extremity
* The patient receives physical therapy and/or occupational therapy rehabilitation treatment
Exclusion Criteria
* Pain that prevents active movement of the upper extremity
* Hemodynamic instability
* Cognitive decline and language difficulties that do not allow understanding of instructions and cooperation.
18 Years
ALL
No
Sponsors
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Reuth Rehabilitation Hospital
OTHER
University of Haifa
OTHER
Responsible Party
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Michal Kafri, PhD
Principal Investigator
Locations
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Reut Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Gadi Bartur, PhD
Role: primary
Other Identifiers
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0012-19-RRH
Identifier Type: -
Identifier Source: org_study_id
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