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

U

University of Haifa

Status and phase

Unknown
Phase 1

Conditions

Hemiparesis;Poststroke/CVA

Treatments

Behavioral: Task-specific practice of upper extremity functions

Study type

Interventional

Funder types

Other

Identifiers

NCT05342688
0012-19-RRH

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

High contextual interference
Experimental group
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.
Treatment:
Behavioral: Task-specific practice of upper extremity functions
Low contextual interference
Active Comparator group
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.
Treatment:
Behavioral: Task-specific practice of upper extremity functions

Trial contacts and locations

1

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Central trial contact

Michal Kafri, PhD

Data sourced from clinicaltrials.gov

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