Implementation of a HABIT-ILE at Home Intervention for Children With Bilateral Cerebral Palsy: a Non-inferiority Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
MSL-IN Lab, Institue of Neurosciences, UCLouvain
RECRUITING
Brussels
Contact Information
Primary
Yannick Bleyenheuft, Phd, Prof.
yannick.bleyenheuft@uclouvain.be
+32 486 91 99 11
Backup
Zélie Rosselli, Phd student
zelie.rosselli@uclouvain.be
+33 6 82 59 79 38
Time Frame
Start Date: 2023-02-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 48
Treatments
Experimental: HABIT-ILE therapy at home without a HABIT-ILE follow-up at home
2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of usual care
Experimental: HABIT-ILE therapy at home with a HABIT-ILE follow-up at home
2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of HABIT-ILE follow-up at home
Active_comparator: Classic HABIT-ILE therapy without follow-up HABIT-ILE at home
2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of usual care
Active_comparator: Classic HABIT-ILE therapy with follow-up HABIT-ILE at home
2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of HABIT-ILE follow-up at home
Related Therapeutic Areas
Sponsors
Leads: Université Catholique de Louvain

This content was sourced from clinicaltrials.gov