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

Condition(s) studied

Investigational drug(s) / intervention(s)

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE): HABIT-ILE ("Hand-Arm Bimanual Intensive Therapy including Lower Extremities") is an intensive therapy that continuously incorporates postural control and LE function. This motor learning-based approach include specificity of the practice, motivation, shaping of the task, intensive blocks of training and Hands-Off. Moreover, the therapy is goal-oriented to increase functional independence during daily living. This therapy has shown impressive improvements in children with PC.

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at home: The HABIT-ILE therapy at home will follow the same principles as the classic HABIT-ILE. The therapy will take place in the patient's home and a close person (caregiver) will accompany the patient during the therapy. A device will be used to facilitate the implementation of home therapy. Supervision of the therapeutic process will be done remotely by a team of trained supervisors. One hour of remote supervision per day will be scheduled within 6.5 hours of therapy.

Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE follow-up at home follow the same principles as classic HABIT-ILE but is delivered at the patient home with 4 hours per week in autonomy and 1 hour per week under supervision.

Usual Care: Usual care is all the weekly physiotherapy and occupational therapy sessions that the patient usually receives.

Study 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

Primary outcome measure(s)

• Change on Gross Motor Function (GMFM-66) — baseline, 2 weeks and 12 weeks after baseline
  Developed to assess the changes in gross motor function of children with cerebral palsy (scored in percentage)

Trial sites (1)

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