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

NCT06428032 | Recruiting DMC

• 1 other identifier: NEUROLAB_UNAB_001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

HABIT-ILE; Intensive motor therapy; Motor skill learning; Children

Outcome Measures

Primary Outcomes (1)

• Changes in Gross Motor Function

  The Gross Motor Function Measure is a standardized observational instrument designed to measure changes in gross motor function over time or following an intervention in children and youth with cerebral palsy using Rasch analysis. It is scored on a scale of 0 to 3, where 0 means the person cannot perform the activity and 3 means the person can complete the item. The score is converted to a percentage. A higher percentage means a better gross motor function.

  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 (17)

• Both Hands Assessment (BoHA)

  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: 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: 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: 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: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

Study Arms (2)

Double period

EXPERIMENTAL

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.

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Single period

EXPERIMENTAL

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

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Interventions

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities BEHAVIORAL

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

Also known as: HABIT-ILE

Double period

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Study Sites (1)

Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello

Santiago, Santiago Metropolitan, 7591538, Chile

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rodrigo Araneda, PhD

  Universidad Nacional Andres Bello

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Araneda, PhD

CONTACT

+56 22 6618608; rodrigo.araneda@unab.cl

Natalia Perez, MSc

CONTACT

+56 22 6618075; n.perezramirez2@uandresbello.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)