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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: MRI; Other: Electro-Encephalography-High Density (children with unilateral PC only); Other: 3D and EMG analysis; Other: care and classic activities; Device: Accelerometers

• Registration Number: NCT04017871
• Lead Sponsor: University Hospital, Brest

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 (= 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.

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), in comparison with two weeks of usual motor activity including usual rehabilitation (control group).

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Study Start: 2019-08-18
• Primary Completion: 2021-09-17
• Study Completion: 2021-09-17
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure (GMFM) (for bilateral CP only)	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.
Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)	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.

Trial Locations

Locations (2)

Les Capucins; 🇫🇷 Angers, France

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