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

Cerebral Palsy Clinical Trial

— HABIT-ILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017871
• Other study ID #: EARLY_HABIT-ILE (29BRC19.0050)
• Status: Completed
• Phase: N/A
• Start date: August 18, 2019
• Est. completion date: September 17, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 17, 2021
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• MRI
MRI at baseline and J90
• Electro-Encephalography-High Density (children with unilateral PC only)
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
• 3D and EMG analysis
3D and EMG analysis at baseline and J90
• care and classic activities
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

Device:
• Accelerometers
During 5 days a sensor at each wrist to quantify their movement.

Locations

Country	Name	City	State
France	Les Capucins	Angers
France	Fondation ILDYS - Site de Ty Yann	Brest

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Brest	Fondation Paralysie Cérébrale, Université Catholique de Louvain, University Angers, University of Lausanne Hospitals, University Pisa

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)	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.	1 hour
Primary	Gross Motor Function Measure (GMFM) (for bilateral CP only)	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