Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy

NCT04020354 | Unknown

• 1 other identifier: B403201316810d
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

Conditions

Cerebral Palsy

Keywords

motor skill learning; functional changes; neuroplastic changes; biomechanical changes

Outcome Measures

Primary Outcomes (2)

• Change on Gross Motor Function (GMFM-66)

  Developed to assess the changes in gross motor function of children with cerebral palsy (scored in percentage), observed over time or after intervention for the second randomized controlled trial (RCT2)

  pre-camp, two weeks post-camp, 3 months follow-up.

• Change on Manual Ability (Assisting Hand Assessment (AHA))

  Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the first randomized controlled trial (RCT1)

  pre-camp, two weeks post-camp, 3 months follow-up

Secondary Outcomes (26)

• Melbourne 2 Assessment (MA2)

  pre-camp, two weeks post-camp, 3 months follow-up

• Inhibitory control task

  pre-camp, two weeks post-camp, 3 months follow-up

• Working memory task

  pre-camp, two weeks post-camp, 3 months follow-up

• Visuo-spatial attention assessment

  pre-camp, two weeks post-camp, 3 months follow-up

• Semmes-Weinstein monofilaments

  pre-camp, two weeks post-camp, 3 months follow-up

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

Early HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.

Behavioral: HABIT-ILE

Usual Care

ACTIVE COMPARATOR

A two weeks period of usual customary care

Behavioral: Usual Care

Interventions

HABIT-ILE BEHAVIORAL

Early Hand and arm bimanual intensive therapy including lower extremities

HABIT-ILE

Usual Care BEHAVIORAL

Usual customary care

Usual Care

Eligibility Criteria

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

You may qualify if:

• children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
• age 1 to 4 years inclusive (corrected age if preterm birth)
• ability to follow instructions and complete testing according to the age.

You may not qualify if:

• active seizure
• programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
• severe visual impairments
• severe cognitive impairments
• contraindications to perform MRI assessments (Metal implants, etc.)

Sponsors & Collaborators

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

Study Sites (3)

Institute of Neuroscience, Université catholique de Louvain

Brussels, 1200, Belgium

Location

Fondation ILDYS - Site de Ty Yann

Brest, France

Location

IRCCS Fondazione Stella Maris

Tirrenia, Tuscany, 56128, Italy

Location

Related Publications (2)

• Araneda R, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Carton de Tournai A, Herman E, Souki A, Le Gal G, Nowak E, Sizonenko SV, Newman CJ, Dinomais M, Riquelme I, Guzzetta A, Brochard S, Bleyenheuft Y. Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):19-28. doi: 10.1001/jamapediatrics.2023.4809.

  PMID: 37930692 DERIVED

• Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.

  PMID: 32290815 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Yannick Bleyenheuft, Pr

  MSL-IN Lab, Institute of Neuroscience, Université catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: July 16, 2019
• Study Start: November 27, 2018
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); BE (1); IT (1)