Trials
Search / Trial NCT06438432

Trunk Activity Rehabilitation in Young Children with Cerebral Palsy

Launched by UNION DE GESTION DES ETABLISSEMENTS DES CAISSES D'ASSURANCE MALADIE - NORD EST · May 27, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a special rehabilitation program called "Rehabilitation by Activities Involving the Trunk" (RAIT) for young children with cerebral palsy (CP). The goal is to see if this program can help improve their trunk control, which is important for walking and balance. Children participating in the trial will be divided into two groups: one will continue their usual rehabilitation for three months before starting RAIT for nine months, while the other will do RAIT for a full twelve months. The researchers want to see if RAIT can reduce issues like unstable walking and improve overall movement.

To be eligible, children must be between 18 months and 5 years old and have specific types of CP that allow them to walk independently. They should also understand simple instructions and be able to participate in exercises. Throughout the trial, researchers will measure progress by checking how well the children walk and balance at different points during the study. This trial is important because it aims to find out if this new way of rehabilitation can be more effective than the usual methods for helping young children with CP.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • For children with CP
  • Age between 18 months and 5 years 6 months
  • CP type: spastic paraparesis or spastic hemiparesis, GMFCS I to II
  • No or moderate retraction of the sural triceps (ankle dorsiflexion: \> 5° on clinical examination, knee straight)
  • Sufficient level of understanding to carry out activities involving the trunk in the form of self-exercises (rehabilitation protocol), as well as clinical assessments and functional explorations.
  • Acceptance by the physiotherapist in charge of the child's follow-up to collaborate in carrying out the RAIT.
  • Affiliated with a social security scheme
  • For children with DT
  • Age between 18 months and 5 years 6 months
  • Walking acquired before age 18 months
  • Sufficient level of understanding to perform clinical assessments and functional explorations
  • Affiliated with a social security scheme
  • Exclusion Criteria:
  • For children with CP
  • Previous surgery on lower limbs less than 1 year ago
  • Botulinum toxin A injection less than 6 months ago
  • Any change in rehabilitative and/or orthopedic management in the last 2 months
  • Hip flessum \> 20
  • Presence of subacute or chronic pain on standing or walking
  • For children with DT
  • - Neurological and/or orthopedic disorders that may influence gait

About Union De Gestion Des Etablissements Des Caisses D'assurance Maladie Nord Est

The Union de Gestion des Établissements des Caisses d'Assurance Maladie - Nord Est is a prominent clinical trial sponsor dedicated to advancing healthcare through rigorous research and innovation. This organization collaborates with various stakeholders in the healthcare sector to design, implement, and oversee clinical trials that aim to improve patient outcomes and enhance medical practices. With a focus on ensuring compliance with regulatory standards and ethical guidelines, the Union plays a vital role in fostering evidence-based medicine in the Nord Est region, ultimately contributing to the broader goal of enhancing public health.

Locations

Nancy, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0