Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities, Hand-Arm Bimanual Intensive Therapy Including Lower Extremities.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in Gross Motor Function [Time frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
Secondary outcome measures (12)
- Both Hands Assessment (BoHA) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]]
- Melbourne 2 Assessment (MA2) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]]
- Test of Arm Selective Control (TASC) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- Selective Control Assessment of the Lower Extremity (SCALE) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- Six minutes walk test (6MWT) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- Attention network test (ANT) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- ABILHAND-Kids questionnaire [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- ACTIVLIM-CP questionnaire [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- Participation and Environment Measure - Children and Youth (PEM-CY) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- Canadian Occupational Performance Measure (COPM) [Time frame: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]
- Behaviour Rating Inventory of Executive Function (BRIEF-2) [Time frame: Time Frame: Baseline (T0), at 3 months (T2), at 6 months (T3), and at 9 months (T5)]
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Chile · 1 center
- Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello — Santiago
Identifiers
NCT: NCT06428032 · NEUROLAB_UNAB_001