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

NCT04017871 | Completed

• 1 other identifier: EARLY_HABIT-ILE (29BRC19.0050)
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy (CP); pre-school children with unilateral and bilateral CP

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Interventional

EXPERIMENTAL

10 days of intensive and structured motor therapy, 5 hours a day = 50h

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

Control

PLACEBO COMPARATOR

10 days of care and classic activities

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

Interventions

MRI OTHER

MRI at baseline and J90

Control; Interventional

Electro-Encephalography-High Density (children with unilateral PC only) OTHER

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

Control; Interventional

3D and EMG analysis OTHER

3D and EMG analysis at baseline and J90

Control; Interventional

care and classic activities OTHER

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

Control; Interventional

Accelerometers DEVICE

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

Control; Interventional

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• Fondation Paralysie Cérébrale: collaborator
• Université Catholique de Louvain: collaborator
• University of Pisa: collaborator
• University of Lausanne Hospitals: collaborator
• University Angers: collaborator

Study Sites (2)

Les Capucins

Angers, France

Location

Fondation ILDYS - Site de Ty Yann

Brest, France

Location

Related Publications (1)

• Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurol. 2020 Jun 12;20(1):243. doi: 10.1186/s12883-020-01820-2.

  PMID: 32532249 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: July 12, 2019
• Study Start: August 18, 2019
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (2)