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

Associations Between Contextual Interference, Engagement During Treatment, and Change in Motor Performance Among Patients Posts-stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Hemiparesis;Poststroke/CVA
• Intervention / Treatment: Behavioral: Task-specific practice of upper extremity functions

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michal Kafri, PhD; Phone Number: 972586862261; Email: kafri.michal@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Reut Medical Center
    • Contact: Gadi Bartur, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Task-specific practice of upper extremity functions; The intervention will consist of training of items from the Wolf motor function test.
Active Comparator: 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.	Behavioral: Task-specific practice of upper extremity functions; The intervention will consist of training of items from the Wolf motor function test.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Reuth Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 0012-19-RRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No