Actively Recruiting

Phase Not Applicable
Age: 5Years - 18Years
All Genders
NCT05740605

Implementation of a HABIT-ILE Intervention at Home for Children With Bilateral Cerebral Palsy

Led by Université Catholique de Louvain · Updated on 2023-03-06

48

Participants Needed

1

Research Sites

253 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Intensive interventions based on the principles of motor skill learning, like Hand-Arm Bimanual Therapy Including Lower Extremities (HABIT-ILE), have demonstrated excellent effectiveness in improving motor function and daily life independence of children with cerebral palsy (CP). Patients living far from big cities do not have easy access to such interventions, usually applied in the form of camps. This randomized controlled trial will include 48 children with bilateral CP and aims to test a home version of HABIT-ILE with the use of a specifically designed virtual device and a remote supervision. For this purpose, two types of two weeks intensive treatment programs will be compared: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities at home ("HABIT-ILE at home") and "classic HABIT-ILE". Moreover, this study also aims to assess whether the patient's abilities are better with a follow-up at home after two weeks of HABIT-ILE therapy than without follow-up post therapy. Four groups will be compared: HABIT-ILE at home therapy with a follow-up at home, HABIT-ILE at home therapy without follow-up, classic HABIT-ILE therapy with a follow-up at home and classic HABIT-ILE therapy without follow-up. Children will be assessed at 3 time points: before therapy, after therapy and 3 months after the start of therapy.

CONDITIONS

Official Title

Implementation of a HABIT-ILE Intervention at Home for Children With Bilateral Cerebral Palsy

Who Can Participate

Age: 5Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with confirmed diagnosis of bilateral Cerebral Palsy
  • Age 5 to 18 years old
  • Ability to interact and understand simple instructions in order to complete assessments and therapy
  • Availability of a caregiver for 6h30 per day during two weeks of therapy
Not Eligible

You will not qualify if you...

  • Uncontrolled seizure
  • Botulinum toxin injection in the last 6 months before the first assessment or during the therapy
  • Intensive therapy in the last 6 months before the first assessment or during the therapy
  • Surgery that could affect the assessments or therapy in the last 6 months before the first assessment or during the therapy
  • Severe visual or cognitive impairments interfering with treatment and or assessments
  • Any typical contraindication for MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MSL-IN Lab, Institue of Neurosciences, UCLouvain

Brussels, Belgium

Actively Recruiting

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Research Team

Y

Yannick Bleyenheuft, Phd, Prof.

CONTACT

Z

Zélie Rosselli, Phd student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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