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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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05342688
Enrollment
50
Registered
2022-04-25
Start date
2020-01-01
Completion date
2023-06-30
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis;Poststroke/CVA

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.

Interventions

BEHAVIORALTask-specific practice of upper extremity functions

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

Sponsors

Reuth Rehabilitation Hospital
CollaboratorOTHER
University of Haifa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Brain Engagement IndexPractice 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

MeasureTime frameDescription
Changes in Heart rate variabilityPractice 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.
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.

Countries

Israel

Contacts

Primary ContactMichal Kafri, PhD
kafri.michal@gmail.com972586862261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026