Skip to main content
OpenTrials
Completed

NCT Number: NCT04362800

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Les Capucins, Angers, France

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Other

MRI at baseline and J90

Electro-Encephalography-High Density

Other

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

3D and EMG analysis

Other

3D and EMG analysis at baseline and J90

care and classic activities

Other

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

Primary outcomes

  1. Gross Motor Function Measure (GMFM)

    Time frame: 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.

Secondary outcomes

  1. Both Hands Assessment

    Time frame: up to 90 days

    Assess the extent to which the more severely affected hand can assist during two-handed activities

  2. Melbourne Assessment 2

    Time frame: up to 90 days

    Assess the quality of movement in children with neurological disorders

  3. ACTIVLIM-CP

    Time frame: up to 90 days

    Assess the child's overall performance during daily activities.

  4. Young Children's Participation and Environment Measure

    Time frame: up to 90 days

    Assess the participation of young children with disabilities and delays in terms of patterns of participation at home, in daycare/preschool, and in the community; perceived environmental supports and barriers to participation; and activity-specific parenting strategies to promote participation

  5. Pediatric Evaluation of Disability Inventory Computer Adaptive Test

    Time frame: up to 90 days

    assess functional abilities in four areas: activities of daily living, mobility, social/cognitive functioning, and self-care.

  6. Canadian Occupational Performance Measure

    Time frame: up to 90 days

    define therapeutic goals and measure the child's progress and the parents' level of satisfaction for each functional goal.

  7. Visual-spatial functions

    Time frame: up to 90 days

    Assessment of tracking ability, visual field exploration, and oculomotor coordination using the assessment kit developed by Prof. Chokron of the Adolphe de Rothschild Ophthalmological Foundation in Paris, France

  8. Healthcare Economic Analysis

    Time frame: through study completion

    to demonstrate the effectiveness of early intensive rehabilitation compared to traditional care through a cost-effectiveness study

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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: a Trial Multicentre Randomized Control With Medico-economic Evaluation

Acronym: MOOV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.