Clinical trial NCT06438432: Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
Official title: Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children With Cerebral Palsy
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Peak anterior deceleration of the sternum at the start of weight-bearing
timeFrame: At inclusion, then 3, 6 and 12 months later
Secondary outcomes:
measure: EMFG-66-SI
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: The Early Clinical Balance Scale
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Global Motor Function Classification System family report questionnaire
timeFrame: At inclusion
measure: "Reach out" questionnaire
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Neuro-orthopaedic assessment
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Neuro-orthopaedic assessment
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Neuro-orthopaedic assessment
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: peak downward deceleration of L5 at the start of support
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Gait variability index
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Cycle width
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Anterior support of the foot during 1st double support
timeFrame: At inclusion, then 3, 6 and 12 months later
measure: Edinburgh walk visual score
timeFrame: At inclusion, then 3, 6 and 12 months later
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
Study officials:
References: