Contextual Interference, Engagement , and Change in Motor Performance in Stroke

Phase 1

• Conditions: Hemiparesis;Poststroke/CVA
• Interventions: Behavioral: Task-specific practice of upper extremity functions

• Registration Number: NCT05342688
• Lead Sponsor: University of Haifa

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-11-09
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-18
• Last Update Submitted: 2022-04-18
• Study First Posted: 2022-04-25
• Last Update Posted: 2022-04-25
• Primary Completion: 2023-01
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High contextual interference	Task-specific practice of upper extremity functions	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.
Low contextual interference	Task-specific practice of upper extremity functions	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.

Primary Outcome Measures

Name	Time	Method
Change in Brain Engagement Index	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)	EEG activity in the prefrontal cortex will be measured by MindWave mobile EEG headset.
Change in time to complete each of three items of the Wolf Motor Function Test (WMFT)	Pre-intervention session (first session), post-intervention session (session 5, 5-7 days following the pre-intervention session))	A maximum of 120 seconds is allowed. Any performance that exceeds 120 seconds is assigned 120 seconds.

Secondary Outcome Measures

Name	Time	Method
Changes in Galvanic Skin Response (GSR)	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)	GSR electrodes will be placed on the index and middle fingers, and the signal is reported in micro-Siemens (μS) units.
Changes in Heart rate variability	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)	Photoplethysmograph sensor will be placed on the ring finger. Data will be used to extract R-R beat interval, and variability will be measured.

Trial Locations

Locations (1)

Reut Medical Center; 🇮🇱 Tel Aviv, Israel