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

Primary Purpose

Hemiparesis;Poststroke/CVA

Status
Recruiting
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Task-specific practice of upper extremity functions
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis;Poststroke/CVA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Reut Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High contextual interference

Low contextual interference

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Brain Engagement Index
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)
A maximum of 120 seconds is allowed. Any performance that exceeds 120 seconds is assigned 120 seconds.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 9, 2021
Last Updated
April 18, 2022
Sponsor
University of Haifa
Collaborators
Reuth Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05342688
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Reuth Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis;Poststroke/CVA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The study will be a randomized controlled trial with a pre-post design.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High contextual interference
Arm Type
Experimental
Arm Description
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.
Arm Title
Low contextual interference
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Task-specific practice of upper extremity functions
Intervention Description
The intervention will consist of training of items from the Wolf motor function test.
Primary Outcome Measure Information:
Title
Change in Brain Engagement Index
Description
EEG activity in the prefrontal cortex will be measured by MindWave mobile EEG headset.
Time Frame
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)
Title
Change in time to complete each of three items of the Wolf Motor Function Test (WMFT)
Description
A maximum of 120 seconds is allowed. Any performance that exceeds 120 seconds is assigned 120 seconds.
Time Frame
Pre-intervention session (first session), post-intervention session (session 5, 5-7 days following the pre-intervention session))
Secondary Outcome Measure Information:
Title
Changes in Heart rate variability
Description
Photoplethysmograph sensor will be placed on the ring finger. Data will be used to extract R-R beat interval, and variability will be measured.
Time Frame
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)
Title
Changes in Galvanic Skin Response (GSR)
Description
GSR electrodes will be placed on the index and middle fingers, and the signal is reported in micro-Siemens (μS) units.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Kafri, PhD
Phone
972586862261
Email
kafri.michal@gmail.com
Facility Information:
Facility Name
Reut Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gadi Bartur, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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