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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Chile
Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello
RECRUITING
Santiago
Contact Information
Primary
Rodrigo Araneda, PhD
rodrigo.araneda@unab.cl
+56 22 6618608
Backup
Natalia Perez, MSc
n.perezramirez2@uandresbello.cl
+56 22 6618075
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 48
Treatments
Experimental: Double period
Subjects will receive 130 hours of HABIT-ILE performed in two intervention periods as camp format for 6,5-hours/day, 5 days/week for two weeks. Each intervention period will be 6-months apart.
Experimental: Single period
Subjects will receive 65 hours of HABIT-ILE performed in one intervention period as camp format for 6,5-hours/day, 5 days/week for two weeks
Related Therapeutic Areas
Sponsors
Leads: Universidad Nacional Andres Bello

This content was sourced from clinicaltrials.gov