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

NCT05342688 | Unknown Phase 1

• 1 other identifier: 0012-19-RRH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis;Poststroke/CVA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

High contextual interference

EXPERIMENTAL

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

Low contextual interference

ACTIVE COMPARATOR

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

Interventions

Task-specific practice of upper extremity functions BEHAVIORAL

The intervention will consist of training of items from the Wolf motor function test.

High contextual interference; Low contextual interference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Haifa: lead
• Reuth Rehabilitation Hospital: collaborator

Study Sites (1)

Reut Medical Center

Tel Aviv, Israel

RECRUITING

Central Study Contacts

Michal Kafri, PhD

CONTACT

972586862261; kafri.michal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking description: The outcome assessor will be blind to the group assignment of the participants. Participants and the investigator who deliver the intervention will be aware of group assignment because it is inherent to the type of practice they receive and deliver respectively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be a randomized controlled trial with a pre-post design.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: April 25, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)