Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy

NCT ID: NCT04362800

Last Updated: 2021-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2021-09-17

Brief Summary

One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.

Detailed Description

The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall motor activity including usual rehabilitation (control group).

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Interventional

10 days of intensive and structured motor therapy, 5 hours a day = 50h

Group Type: EXPERIMENTAL

MRI

Intervention Type: OTHER

MRI at baseline and J90

Electro-Encephalography-High Density

Intervention Type: OTHER

Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90

3D and EMG analysis

Intervention Type: OTHER

3D and EMG analysis at baseline and J90

care and classic activities

Intervention Type: OTHER

physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

Control

10 days of care and classic activities

Group Type: PLACEBO_COMPARATOR

MRI

Intervention Type: OTHER

MRI at baseline and J90

Electro-Encephalography-High Density

Intervention Type: OTHER

Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90

3D and EMG analysis

Intervention Type: OTHER

3D and EMG analysis at baseline and J90

care and classic activities

Intervention Type: OTHER

physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

Interventions

MRI

MRI at baseline and J90

Intervention Type: OTHER

Electro-Encephalography-High Density

Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90

Intervention Type: OTHER

3D and EMG analysis

3D and EMG analysis at baseline and J90

Intervention Type: OTHER

care and classic activities

physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Child with bilateral cerebral palsy proven to be spastic or dyskinetic
• 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age
• Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS)
• Signature of consent by the two holders of parental authority

Exclusion Criteria

• Exceed 4 years and 11 months (59 months) during the internship evaluation period.
• Uncontrolled epilepsy.
• History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period).
• Visual or cognitive deficit preventing the child from seeing the games and interacting
• Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Les Capucins

Angers, , France

Fondation ILDYS - Site de Ty Yann

Brest, , France

Countries

France

Other Identifiers

MOOV (29BRC20.0046)

Identifier Type: -

Identifier Source: org_study_id