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

NCT04362800 | Completed

• 1 other identifier: MOOV (29BRC20.0046)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy (CP); pre-school children with bilateral CP

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure (GMFM)

  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.

  1 hour

Secondary Outcomes (8)

• Both Hands Assessment

  up to 90 days

• Melbourne Assessment 2

  up to 90 days

• ACTIVLIM-CP

  up to 90 days

• Young Children's Participation and Environment Measure

  up to 90 days

• Pediatric Evaluation of Disability Inventory Computer Adaptive Test

  up to 90 days

Study Arms (2)

Interventional

EXPERIMENTAL

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

Other: MRI; Other: Electro-Encephalography-High Density; Other: 3D and EMG analysis; Other: care and classic activities

Control

PLACEBO COMPARATOR

10 days of care and classic activities

Other: MRI; Other: Electro-Encephalography-High Density; Other: 3D and EMG analysis; Other: care and classic activities

Interventions

MRI OTHER

MRI at baseline and J90

Control; Interventional

Electro-Encephalography-High Density OTHER

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

Control; Interventional

3D and EMG analysis OTHER

3D and EMG analysis at baseline and J90

Control; Interventional

care and classic activities OTHER

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

Control; Interventional

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child with bilateral cerebral palsy proven to be spastic or dyskinetic
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Les Capucins

Angers, Angers, 49000, France

Location

Fondation ILDYS - Site de Ty Yann

Brest, Brest, 29000, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: January 19, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (2)