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

Hemiparesis;Poststroke/CVA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342688
• Other study ID #: 0012-19-RRH
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2020
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: University of Haifa
• Contact: Michal Kafri, PhD
• Phone: 972586862261
• Email: kafri.michal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis;Poststroke/CVA
• Paresis

Intervention

Behavioral:
• Task-specific practice of upper extremity functions
The intervention will consist of training of items from the Wolf motor function test.

Locations

Country	Name	City	State
Israel	Reut Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Reuth Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)