Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorUniversidad Nacional Andres Bello

About this trial

This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study.

Eligibility criteria

Qualifiers

Children with medical diagnosis of bilateral cerebral palsy

Cognitive capacity and language that allows understanding and following the therapist's instructions.

Manual Ability Classification System (MACS) levels I to III

Bimanual Fine Motor Function (BFMF) levels I to III

Disqualifiers

Severe visual problems

Movement restriction due to orthopedic surgery in less than a year

Treatment with botulinum toxin and/or baclofen pump in the last 6 months

Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.)

Trial design

Treatments tested in this trial

  • Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
  • Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Treatment groups

48 Participants
are divided into 2 treatment groups