Intensive Bimanual Intervention in Cerebral Palsy Children

Official title

Predictors of Response to an Intensive Bimanual Intervention in Children With Cerebral Palsy

Overview

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.

Interventions

• Other Intensive bimanual therapy
  60-hour intensive therapy promoting the use of both hands (ex: bimanual activities, games,...)

Primary outcome measures

• Magnetic Resonance Imaging (MRI) [Time frame: Measured prior to the intervention.]
• Robotic evaluation - Visually guided reaching [Time frame: Measured prior to the intervention.]
• Robotic evaluation - Visually guided reaching [Time frame: Measured one week post-intervention.]
• Robotic evaluation - Visually guided reaching [Time frame: Measured 6-month post-intervention.]
• Robotic evaluation - Object hit [Time frame: Measured prior to the intervention.]
• Robotic evaluation - Object hit [Time frame: Measured one week post-intervention.]
• Robotic evaluation - Object hit [Time frame: Measured 6-month post-intervention.]
• Robotic evaluation - Ball on bar [Time frame: Measured prior to the intervention.]
• Robotic evaluation - Ball on bar [Time frame: Measured one week post-intervention.]
• Robotic evaluation - Ball on bar [Time frame: Measured 6-month post-intervention.]

Secondary outcome measures (6)

• Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ) [Time frame: Measured prior to the intervention.]
• Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ) [Time frame: Measured one week post-intervention.]
• Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ) [Time frame: Measured 6-month post-intervention.]
• Self-assessments - Canadian Occupational Performance Measure (COPM) [Time frame: Measured prior to the intervention.]
• Self-assessments - Canadian Occupational Performance Measure (COPM) [Time frame: Measured one week post-intervention.]
• Self-assessments - Canadian Occupational Performance Measure (COPM) [Time frame: Measured 6-month post-intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Université Laval — Québec

Identifiers

NCT: NCT05423171 · Manœuvre

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗