Clinical trial NCT05342688: Contextual Interference, Engagement , and Change in Motor Performance in Stroke
Official title: Associations Between Contextual Interference, Engagement During Treatment, and Change in Motor Performance Among Patients Posts-stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hemiparesis;Poststroke/CVA
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Reuth Rehabilitation Hospital
First posted: 2022-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized controlled trial with a pre-post design.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Five days to 1-year post-stroke
* 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:

* A history of neurological diseases other than stroke or orthopedics conditions that impair upper extremity function
* 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.

Primary outcomes:
measure: Change in Brain Engagement Index
timeFrame: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
measure: Change in time to complete each of three items of the Wolf Motor Function Test (WMFT)
timeFrame: Pre-intervention session (first session), post-intervention session (session 5, 5-7 days following the pre-intervention session))
Secondary outcomes:
measure: Changes in Heart rate variability
timeFrame: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
measure: Changes in Galvanic Skin Response (GSR)
timeFrame: Practice session 1 (1-2 days following pre-intervention session), practice session 2 (1-2 days following practice session1), and practice session 3 (1-2 days following practice session1)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Reut Medical Center
Study officials:
References: