Trunk Activity Rehabilitation in Young Children With Cerebral Palsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-6
SponsorUnion de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAIT

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: RH-RAITExperimental treatment 1 intervention
Group B: RAIT-RAITExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
At inclusion, then 3, 6 and 12 months later

Secondary outcomes

1

EMFG-66-SI

The Evaluation Motrice Fonctionnelle Globale 66 (EMFG-66) is a standardized 66-item clinical score used to assess global motor function and its evolution over time in children with cerebral palsy. The EMFG-66-SI is a faster (approx. 20 to 30 minutes vs. 60 to 80 minutes), validated scoring method for the EMFG-66, using 15 to 39 items. The higher the score, the better.

Time frame
At inclusion, then 3, 6 and 12 months later
2

The Early Clinical Balance Scale

This is a 13-item clinical scale for assessing postural stability (balance ability) in children with cerebral palsy, with two subscales: one dedicated to head and trunk postural control, the other to sitting and standing postural control.The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level (40,47). The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level.)The optimal score is 100. Administering the scale takes around 15 minutes. The higher the score, the better.

Time frame
At inclusion, then 3, 6 and 12 months later
3

Global Motor Function Classification System family report questionnaire

This questionnaire for parents, based on the child's voluntary movements for sitting, transferring and mobility, provides a 5-level classification of the severity of the child's cerebral palsy. Score between 1 and 5. The higher the score, the more severe the cerebral palsy.

Time frame
At inclusion
4

"Reach out" questionnaire

This is a questionnaire designed for parents to assess the upper limb and hand abilities in different functional situations of their child with CP. This questionnaire, validated for children with CP from the age of 2, will help to assess the expected improvement in hand and upper limb function linked to RAIT. The higher the score, the better.

Time frame
At inclusion, then 3, 6 and 12 months later

Other outcomes

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