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

NCT06428032 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-07-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Universidad Nacional Andres Bello

    lead OTHER

Principal Investigators

  • Rodrigo Araneda, PhD · Universidad Nacional Andres Bello

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2026-09-30
Completion
2027-12-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06428032 on ClinicalTrials.gov