Intensive Bimanual Intervention in Cerebral Palsy Children

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Université Laval — Québec

Идентификаторы

NCT: NCT05423171 · Manœuvre

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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