NCT06428032

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

Functional and Neuroplastic Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Children With Bilateral Cerebral Palsy: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Universidad Nacional Andres Bello · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study aims to compare, for the first time, the effects of a double period of HABIT-ILE therapy on functional and neuroplastic changes against a single period, in people with bilateral cerebral palsy (CP). Previous HABIT-ILE protocols have only assessed the effects of a single intervention period. Still, the literature suggests a possible dose-response relationship between the number of intensive therapy periods and progress in motor function. A randomized controlled trial will be conducted, comparing the effects of a double period of HABIT-ILE; (2HG; n=24) versus a single period (1HG; n=24) in children and youth with bilateral CP. Each HABIT-ILE period will consider 6.5 hours of intervention during 10 consecutive working days. Children will be assessed at 6-time points: baseline, three weeks after, at 3 months, at 6 months, at 7 months, and at 9 months, to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables. The 1HG will receive only 65 hours of HABIT-ILE after baseline; the 2HG will perform 130 hours over two intervention periods, after baseline and again at 6 months. Overall, this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP. It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BEHAVIORAL	Hand-Arm Bimanual Intensive Therapy Including Lower Extremities	Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.
BEHAVIORAL	Hand-Arm Bimanual Intensive Therapy Including Lower Extremities	Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-09-30
• Completion: 2027-12-31
• First posted: 2024-05-24
• Last updated: 2024-07-11

Locations

1 site across 1 country: Chile