Actively Recruiting

Phase Not Applicable
Age: 8Years - 18Years
All Genders
NCT06428032

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

Led by Universidad Nacional Andres Bello · Updated on 2024-07-11

48

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 such as epileptic history, metallic implants, or neoplasm

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello

Santiago, Santiago Metropolitan, Chile, 7591538

Actively Recruiting

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Research Team

R

Rodrigo Araneda, PhD

CONTACT

N

Natalia Perez, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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