HABIT-ILE in Infants and Toddlers With Cerebral Palsy (Baby HABIT-ILE)

NCT04698395 | Unknown

• 1 other identifier: B403201316810g
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Changes on the Mini-Assisting Hand Assessment (Mini-AHA)

  Measures how well infants (8-18 months) with signs of unilateral or hemiplegic cerebral palsy use their more affected hand, when using both hands together to play (scored in percentage).

  baseline, 3 weeks, 13 weeks and 26 weeks after baseline

Secondary Outcomes (18)

• Changes in Bayley Scales of Infant and Toddler Development - Third Edition (BSID-III)

  baseline, 3 weeks, 13 weeks and 26 weeks after baseline

• Changes in Gross Motor Function Measure - 66 (GMFM-66)

  baseline, 3 weeks, 13 weeks and 26 weeks after baseline

• Changes in Visuo-spatial attention assessment with the "Batterie d'évaluation du Jeune Enfant" (BAJE)

  baseline, 3 weeks, 13 weeks and 26 weeks after baseline

• State of visual impairment of peripheral origin assessed with the standard Battery of Ophthalmological test for infants

  baseline

• Changes in Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT)

  baseline, 3 weeks, 13 weeks and 26 weeks after baseline

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

Baby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)

Regular care

ACTIVE COMPARATOR

Usual customary care intervention during two weeks

Behavioral: Regular care

Interventions

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) BEHAVIORAL

motor learning-based, intensive therapy for children with cerebral palsy

Also known as: Baby HABIT-ILE

HABIT-ILE

Regular care BEHAVIORAL

customary or usual care given to any infant/toddler with cerebral palsy

Also known as: Usual care

Regular care

Eligibility Criteria

• Age: 8 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with diagnosed unilateral cerebral palsy or at risk of developing unilateral cerebral palsy or with signs of unilateral cerebral palsy
• age 8 to 18 months 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 6 months after the intervention time.
• severe visual impairments
• severe cognitive impairments
• contraindications to perform magnetic image resonance (MRI) assessments (metal implants, etc.)

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• University Hospital of Mont-Godinne: collaborator

Study Sites (1)

Institute of Neuroscience, Université catholique de Louvain

Brussels, 1200, Belgium

RECRUITING

Related Publications (2)

• Carton de Tournai A, Herman E, Ebner-Karestinos D, Gathy E, Araneda R, Renders A, De Clerck C, Kilcioglu S, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Infants With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445133. doi: 10.1001/jamanetworkopen.2024.45133.

  PMID: 39556397 DERIVED

• Carton de Tournai A, Herman E, Gathy E, Ebner-Karestinos D, Araneda R, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Baby HABIT-ILE intervention: study protocol of a randomised controlled trial in infants aged 6-18 months with unilateral cerebral palsy. BMJ Open. 2024 Feb 17;14(2):e078383. doi: 10.1136/bmjopen-2023-078383.

  PMID: 38367973 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, PhD

  MSL-IN Lab, Institute of Neuroscience, UCLouvain

  PRINCIPAL INVESTIGATOR

• Yves Vandermeeren, MD, PhD

  Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Bleyenheuft, PhD

CONTACT

+3227645446; yannick.bleyenheuft@uclouvain.be

Daniela Ebner, PhD

CONTACT

+3227645446; daniela.ebner@uclouvain.be

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: SPONSOR

Model Details: Allocation

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 6, 2021
• Study Start: February 15, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)