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

Universidad Nacional Andres Bello

Status

Enrolling

Conditions

Cerebral Palsy

Treatments

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Study type

Interventional

Funder types

Other

Identifiers

NCT06428032

NEUROLAB_UNAB_001

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

Double period

Experimental group

Description:

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.

Treatment:

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Single period

Experimental group

Description:

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

Treatment:

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities