Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Brest

Collaborating Sponsors:

Fondation Paralysie Cérébrale

Université Catholique de Louvain

Conditions:

Cerebral Palsy

Eligibility:

All Genders

12-59 years

Phase:

NA

Brief Summary

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 (= HAB...

Detailed Description

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), i...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 18 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 17 2021

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT04017871

Start Date

August 18 2019

End Date

September 17 2021

Last Update

December 7 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Les Capucins

Angers, France

2

Fondation ILDYS - Site de Ty Yann

Brest, France

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 | DecenTrialz