Clinical trial NCT05423171: Intensive Bimanual Intervention in Cerebral Palsy Children
Official title: Predictors of Response to an Intensive Bimanual Intervention in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Intensive bimanual therapy
Upper limb motor function
Rehabilitation
Motor learning
Accelerometry
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Motor disorders related to cerebral palsy are often accompanied by sensory, cognitive, perceptive, communication and behavioural impairments. It has already been shown that intensive bimanual intervention can improve arm movement, but its impact on the spontaneous use of the most affected arm in everyday life remains to be established. This project aims to understand the impacts of an intensive bimanual therapy on uni- and bi-manual motor functions as well as the spontaneous use of the most affected arm. Predictive value of neuroimaging variables will also be assessed.

Detailed description: Most activities of everyday life require the use of both hands in a coordinated manner. Motor disorders related to cerebral palsy lead to activity limitations due to motor function disturbances. It has already been shown that intensive bimanual intervention can improve arm movement, but its impact on the spontaneous use of the most affected arm in everyday life remains to be established. This project aims to understand the impacts of intensive bimanual therapy on the motor functions of both arms (working together or in isolation) as well as on the spontaneous use of the most affected limb. Predictive value of neuroimaging variables will also be assessed. Thirty children living with cerebral palsy will be recruited over a 5-year period. The intervention consists of a day camp, where a small group of participants will be stimulated (one worker per child) to do activities using both hands 6 hours/day for 10 days. There will be three periods of evaluation (pre-intervention, post-intervention and 6-month follow-up). These evaluation periods consist of neuroimaging assessment, clinical evaluation, robotic evaluation and movement evaluation using inertial control units. The use of more accurate measurements of sensorimotor arm functions using robotic systems will clarify the relationship between measurements of brain function and clinical improvements, to better understand the significant variability observed in response to interventions.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of cerebral palsy or spastic hemiparesis encephalopathy
* Having sensorimotor deficits of one or both upper limb (spastic hemiparesis with a dominance on one side of the body; Manual Ability Classification System (MACS) level

  1, 2 or 3);
* Having cognitive capacities to understand and perform task of the study.

Exclusion Criteria:

* Presenting other significant health problem which may interfere with the requested task or with the clinical intervention;
* Having Botox injection in one or both upper limbs with the 4 months prior to the intervention;
* Presenting significant uncorrected visual deficits.

N.B. Having a ferromagnetic implant is not an exclusion criterion, such participant will be eligible but will not perform the MRI.

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Measured prior to the intervention.
measure: Robotic evaluation - Visually guided reaching
timeFrame: Measured prior to the intervention.
measure: Robotic evaluation - Visually guided reaching
timeFrame: Measured one week post-intervention.
measure: Robotic evaluation - Visually guided reaching
timeFrame: Measured 6-month post-intervention.
measure: Robotic evaluation - Object hit
timeFrame: Measured prior to the intervention.
measure: Robotic evaluation - Object hit
timeFrame: Measured one week post-intervention.
measure: Robotic evaluation - Object hit
timeFrame: Measured 6-month post-intervention.
measure: Robotic evaluation - Ball on bar
timeFrame: Measured prior to the intervention.
measure: Robotic evaluation - Ball on bar
timeFrame: Measured one week post-intervention.
measure: Robotic evaluation - Ball on bar
timeFrame: Measured 6-month post-intervention.
measure: Robotic evaluation - Arm-position matching
timeFrame: Measured prior to the intervention.
measure: Robotic evaluation - Arm-position matching
timeFrame: Measured one week post-intervention.
measure: Robotic evaluation - Arm-position matching
timeFrame: Measured 6-month post-intervention.
measure: Spontaneous use of both arms
timeFrame: Measured during two-days prior to the intervention.
measure: Spontaneous use of both arms
timeFrame: Measured two days during the intervention.
measure: Spontaneous use of both arms
timeFrame: Measured during two-days one week post-intervention.
measure: Spontaneous use of both arms
timeFrame: Measured during two-days 6-month post-intervention.
measure: Clinical evaluation -Two-point discrimination test (TPDT)
timeFrame: Measured prior to the intervention.
measure: Clinical evaluation -Two-point discrimination test (TPDT)
timeFrame: Measured one week post-intervention.
measure: Clinical evaluation -Two-point discrimination test (TPDT)
timeFrame: Measured 6-month post-intervention.
measure: Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
timeFrame: Measured prior to the intervention.
measure: Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
timeFrame: Measured one week post-intervention.
measure: Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
timeFrame: Measured 6-month post-intervention.
measure: Clinical evaluation - Box and Blocks Test (BBT)
timeFrame: Measured prior to the intervention.
measure: Clinical evaluation - Box and Blocks Test (BBT)
timeFrame: Measured one week post-intervention.
measure: Clinical evaluation - Box and Blocks Test (BBT)
timeFrame: Measured 6-month post-intervention.
measure: Clinical evaluation - Assisting Hand Assessment (AHA)
timeFrame: Measured prior to the intervention.
measure: Clinical evaluation - Assisting Hand Assessment (AHA)
timeFrame: Measured one week post-intervention.
measure: Clinical evaluation - Assisting Hand Assessment (AHA)
timeFrame: Measured 6-month post-intervention.
measure: Clinical evaluation - Two-Arm Coordination Test (TACT)
timeFrame: Measured prior to the intervention.
measure: Clinical evaluation - Two-Arm Coordination Test (TACT)
timeFrame: Measured one week post-intervention.
measure: Clinical evaluation - Two-Arm Coordination Test (TACT)
timeFrame: Measured 6-month post-intervention.
measure: Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)
timeFrame: Measured prior to the intervention.
measure: Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)
timeFrame: Measured one week post-intervention.
measure: Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)
timeFrame: Measured 6-month post-intervention.
Secondary outcomes:
measure: Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)
timeFrame: Measured prior to the intervention.
measure: Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)
timeFrame: Measured one week post-intervention.
measure: Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)
timeFrame: Measured 6-month post-intervention.
measure: Self-assessments - Canadian Occupational Performance Measure (COPM)
timeFrame: Measured prior to the intervention.
measure: Self-assessments - Canadian Occupational Performance Measure (COPM)
timeFrame: Measured one week post-intervention.
measure: Self-assessments - Canadian Occupational Performance Measure (COPM)
timeFrame: Measured 6-month post-intervention.
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Université Laval
Study officials:
References: