MedTrace Logo

Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy

NCT04017871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-12-07

No results posted yet for this study

Summary

An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.

Conditions

  • Cerebral Palsy

Interventions

OTHER

MRI

MRI at baseline and J90

OTHER

Electro-Encephalography-High Density (children with unilateral PC only)

Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90

OTHER

3D and EMG analysis

3D and EMG analysis at baseline and J90

OTHER

care and classic activities

physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

DEVICE

Accelerometers

During 5 days a sensor at each wrist to quantify their movement.

Sponsors & Collaborators

  • Fondation Paralysie Cérébrale

    collaborator OTHER

  • Université Catholique de Louvain

    collaborator OTHER

  • University of Pisa

    collaborator OTHER

  • University of Lausanne Hospitals

    collaborator OTHER

  • University Angers

    collaborator UNKNOWN

  • University Hospital, Brest

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-18
Primary Completion
2021-09-17
Completion
2021-09-17

Countries

  • France

Study Locations

More Related Trials

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 NCT04017871 on ClinicalTrials.gov