Clinical trial NCT06428032: Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: HABIT-ILE
Intensive motor therapy
Motor skill learning
Children
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Changes in Gross Motor Function
timeFrame: 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 outcomes:
measure: Both Hands Assessment (BoHA)
timeFrame: 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)]
measure: Melbourne 2 Assessment (MA2)
timeFrame: 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)]
measure: Test of Arm Selective Control (TASC)
timeFrame: 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)
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: 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)
measure: Six minutes walk test (6MWT)
timeFrame: 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)
measure: Attention network test (ANT)
timeFrame: 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)
measure: ABILHAND-Kids questionnaire
timeFrame: 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)
measure: ACTIVLIM-CP questionnaire
timeFrame: 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)
measure: Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
timeFrame: 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)
measure: Participation and Environment Measure - Children and Youth (PEM-CY)
timeFrame: 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)
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 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)
measure: Behaviour Rating Inventory of Executive Function (BRIEF-2)
timeFrame: Time Frame: Baseline (T0), at 3 months (T2), at 6 months (T3), and at 9 months (T5)
measure: Changes of peak-to-peak amplitude of motor evoked potential
timeFrame: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
measure: Changes of Resting Motor Threshold
timeFrame: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
measure: Changes of latency in motor evoked potential
timeFrame: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
measure: Changes of oxyhemoglobin concentration in sensorimotor cortex
timeFrame: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
measure: Changes of oxyhemoglobin concentration in prefrontal cortex
timeFrame: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello
state: Region Metropolitana
Study officials:
affiliation: Universidad Nacional Andres Bello
name: Rodrigo Araneda, PhD
role: PRINCIPAL_INVESTIGATOR
References: