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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: MRI; Other: Electro-Encephalography-High Density; Other: 3D and EMG analysis; Other: care and classic activities

• Registration Number: NCT04362800
• Lead Sponsor: University Hospital, Brest

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).

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-27
• Study Start: 2021-01-19
• Primary Completion: 2021-09-17
• Study Completion: 2021-09-17
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	3D and EMG analysis	10 days of intensive and structured motor therapy, 5 hours a day = 50h
Interventional	Electro-Encephalography-High Density	10 days of intensive and structured motor therapy, 5 hours a day = 50h
Interventional	MRI	10 days of intensive and structured motor therapy, 5 hours a day = 50h
Interventional	care and classic activities	10 days of intensive and structured motor therapy, 5 hours a day = 50h
Control	MRI	10 days of care and classic activities
Control	Electro-Encephalography-High Density	10 days of care and classic activities
Control	3D and EMG analysis	10 days of care and classic activities
Control	care and classic activities	10 days of care and classic activities

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure (GMFM)	1 hour	Measures change in gross motor function over time in children with cerebral palsy. The score range from 0 to 100 as a percentage. 100 is the best outcome.

Trial Locations

Locations (2)

Les Capucins; 🇫🇷 Angers, France

Fondation ILDYS - Site de Ty Yann; 🇫🇷 Brest, France