Trunk Activity Rehabilitation in Young Children With Cerebral Palsy

NCT06438432 | Recruiting

• 1 other identifier: 2023-A01969-36
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Children With Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Peak anterior deceleration of the sternum at the start of weight-bearing

  Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation.

  At inclusion, then 3, 6 and 12 months later

Secondary Outcomes (12)

• EMFG-66-SI

  At inclusion, then 3, 6 and 12 months later

• The Early Clinical Balance Scale

  At inclusion, then 3, 6 and 12 months later

• Global Motor Function Classification System family report questionnaire

  At inclusion

• "Reach out" questionnaire

  At inclusion, then 3, 6 and 12 months later

• Neuro-orthopaedic assessment

  At inclusion, then 3, 6 and 12 months later

Study Arms (2)

RH-RAIT

EXPERIMENTAL

A first group of children will continue their usual rehabilitation (RH) for the first 3 months and then have RAIT for the following 9 months.

Other: RAIT

RAIT-RAIT

EXPERIMENTAL

The second group of children will have RAIT from the outset during the 12 months of the study.

Other: RAIT

Interventions

RAIT OTHER

The RAIT program focuses on improving postural control and balance of the entire body, including the trunk and other affected muscles, through autonomous actions in intermediate postures. This approach uses fundamental automatic control of postural support and balance to enhance the use of affected muscles during all postural and locomotor tasks. The child controls their balance during various voluntary actions from intermediate postures like alternating between four-legged and cobra postures, or swinging from the camel posture. These actions, less difficult than standing and walking, are expected to benefit the latter. The child also performs more challenging trunk movements, requiring dissociation of scapular and pelvic girdle movements or reducing lumbar lordosis.

RAIT-RAIT; RH-RAIT

Eligibility Criteria

• Age: 18 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est: lead

Study Sites (1)

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

RECRUITING

Central Study Contacts

Jonathan Pierret, PhD

CONTACT

+33 3 83 52 6761; jonathan.pierret@ugecam.assurance-maladie.fr

Christian Beyaert, PU-PH

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)