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

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT05740605

Run by

Université Catholique de Louvain

People needed

48

Starts

2023-02-22

Expected to finish

2027-12-31

Last updated by the study team

2023-03-06

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MSL-IN Lab, Institue of Neurosciences, UCLouvain — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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