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Completed

NCT Number: NCT04017871

Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy

An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Les Capucins, Angers, France

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About this study

The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE on gross motor function in pre-school children with unilateral and and bilateral Cerebral Paralysy (CP), in comparison with two weeks of usual 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 unilateral cerebral palsy or Child with bilateral cerebral palsy proven spastic or dyskinetic
  • Aged from 1 to 4 years old (12 to 59 months) (age corrected if prematurity) able to follow instructions and to be able to carry out all the evaluations, according to his age

Exclusion criteria

  • Age> 2 years old (35 months) or 4 years old (59 months) during the internship evaluation period
  • Uncontrolled epilepsy
  • History of botulinum toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period)
  • Visual or cognitive impairment that may interfere with the management
  • Common 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 (children with unilateral PC only)

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.

Accelerometers

Device

During 5 days a sensor at each wrist to quantify their movement.

Primary outcomes

  1. Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)

    Time frame: 1 hour

    measures and describes how children with upper limb disability in one hand use his/her affected hand collaboratively with the non affected hand in bimanual play.The score range from 0 to 100 as a percentage. 100 is the best outcome.

  2. Gross Motor Function Measure (GMFM) (for bilateral CP only)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Angers University
  • Fondation Paralysie Cérébrale
  • University of Lausanne Hospitals
  • University of Pisa
  • Université Catholique de Louvain

Registry information

Acronym: HABIT-ILE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2019
Registry last updated
Dec 7, 2021

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.

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