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

NCT ID: NCT06428032

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Intervention Type: BEHAVIORAL

Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.

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

Group Type: EXPERIMENTAL

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Intervention Type: BEHAVIORAL

Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

HABIT-ILE; HABIT-ILE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional Andres Bello

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Araneda, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Araneda, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional Andres Bello

Locations

Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Rodrigo Araneda, PhD

Role: CONTACT

rodrigo.araneda@unab.cl

+56 22 6618608

Natalia Perez, MSc

Role: CONTACT

n.perezramirez2@uandresbello.cl

+56 22 6618075

Facility Contacts

Rodrigo Araneda, PhD

Role: primary

Other Identifiers

NEUROLAB_UNAB_001

Identifier Type: -

Identifier Source: org_study_id