Actively Recruiting

Phase Not Applicable
Age: 18Months - 6Years
All Genders
Healthy Volunteers
NCT06438432

Trunk Activity Rehabilitation in Young Children With Cerebral Palsy

Led by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Updated on 2025-08-27

32

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Children with CP exhibit trunk control issues from early childhood, affecting their balance and gait. These issues manifest as unstable walking, increased step width, and more pronounced anterior deceleration of the sternum. Previous studies have shown that early action of the triceps surae compensates for the deficit in trunk postural control. Rehabilitation targeting the trunk has shown significant improvements in postural control and gait. The main objective is to demonstrate that RAIT (Rehabilitation by Activities Involving the Trunk) significantly reduces the peak anterior deceleration of the sternum at the beginning of the stance phase during barefoot spontaneous walking, with an enhanced effect from prolonged RAIT duration. Secondary objectives include reducing the downward deceleration of the fifth lumbar vertebra (L5), step width, gait variability index, and improving scores on the early clinical balance scale and the global motor function evaluation. Participants, children with spastic paraparesis or spastic hemiparesis capable of walking independently, are divided into two groups: one group continuing their usual rehabilitation for 3 months followed by RAIT for 9 months (RH-RAIT), and one group following RAIT for 12 months (RAIT-RAIT). RH involves rehabilitation exercises for lower limb muscles, while RAIT focuses on improving trunk postural control through activities involving intermediate postures. Functional motor assessments will be conducted initially, then at 3, 6, and 12 months. These include clinical evaluations, gait analysis (step width, gait variability index, anterior foot support), and an analysis of static standing displacement using an inertial sensor placed at L5. At M0, children with CP are expected to show higher values for deceleration peaks and gait variability indices, and lower scores on evaluation scales compared to typically developing (TD) children. After RAIT, an improvement in judgment criteria is expected: reduction in deceleration peaks, cycle width, gait variability index, anterior foot support, and an increase in scores on the ECPE and EMFG-66-SI. This study aims to confirm that rehabilitation through trunk-involving activities is more effective than usual rehabilitation in improving postural control and gait dynamics in young children with cerebral palsy, suggesting that this approach could become a standard rehabilitation practice from early childhood.

CONDITIONS

Official Title

Trunk Activity Rehabilitation in Young Children With Cerebral Palsy

Who Can Participate

Age: 18Months - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged between 18 months and 5 years 6 months
  • Diagnosed with spastic paraparesis or spastic hemiparesis cerebral palsy, GMFCS level I or II
  • No or moderate calf muscle stiffness (ankle dorsiflexion greater than 5° with knee straight)
  • Able to understand and perform trunk-focused exercises and assessments
  • Approved by the child's physiotherapist to participate in RAIT
  • Affiliated with a social security scheme
  • For typically developing children: aged 18 months to 5 years 6 months
  • Walking ability acquired before 18 months
  • Able to understand and perform clinical assessments
  • Affiliated with a social security scheme
Not Eligible

You will not qualify if you...

  • Lower limb surgery within the last year
  • Botulinum toxin A injection within the last 6 months
  • Any change in rehabilitation or orthopedic management in the past 2 months
  • Hip flexion contracture greater than 20°
  • Presence of subacute or chronic pain during standing or walking
  • For typically developing children: neurological or orthopedic disorders affecting gait

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut Régional de Médecine Physique et de Réadaptation

Nancy, France, 54000

Actively Recruiting

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Research Team

J

Jonathan Pierret, PhD

CONTACT

C

Christian Beyaert, PU-PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Trunk Activity Rehabilitation in Young Children With Cerebral Palsy | DecenTrialz