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

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID: NCT06428032
Run by: Universidad Nacional Andres Bello
People needed: 48
Starts: 2024-06-03
Expected to finish: 2027-12-31
Last updated by the study team: 2024-07-11

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Gross Motor Function Classification System (GMFCS) levels I to III

You may not qualify if…

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.)

Where it is running

Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello — Santiago, Santiago Metropolitan, Chile (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.