Children With Cerebral PalsyActiv'TroncNCT06438432
Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
A study testing RAIT in people with Children With Cerebral Palsy, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Cerebral Palsy
- What is being tested?
- RAIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2024to 31 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Beyaert, PU-PH contact
France1 site, 1 recruiting
- Recruiting
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
Jonathan Pierret, PhD, +33 3 82 52 6761, jonathan.pierret@ugecam.assurance-maladie.fr
Christian Beyaert, PU-PH
About this study
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.
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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
- Being tested
- RAIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAITOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: RAIT |
| RAIT-RAIT | Experimental | The second group of children will have RAIT from the outset during the 12 months of the study. Receives: Other: RAIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion, then 3, 6 and 12 months later
Secondary outcomes (12)
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.
Measured: At inclusion, then 3, 6 and 12 months later
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.
Measured: At inclusion, then 3, 6 and 12 months later
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.
Measured: At inclusion
"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.
Measured: At inclusion, then 3, 6 and 12 months later
Neuro-orthopaedic assessment
This examination consists of measuring the amplitude of movement of the main joints in one or more planes, using a goniometer. Check against standards for each joint
Measured: At inclusion, then 3, 6 and 12 months later
Neuro-orthopaedic assessment
This examination consists of measuring spasticity of the main muscles, by mobilizing a joint at slow and then fast speed to elicit a stretch reflex. Score between 0 and 4. 4 indicates the highest level of spasticity.
Measured: At inclusion, then 3, 6 and 12 months later
Neuro-orthopaedic assessment
This examination consists of measuring the muscular strength of the main muscle groups, by asking the subject to mobilize a joint against resistance. Score between 0 and 5. The higher the score, the better.
Measured: At inclusion, then 3, 6 and 12 months later
peak downward deceleration of L5 at the start of support
varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation.
Measured: At inclusion, then 3, 6 and 12 months later
Gait variability index
Composite score based on 9 spatio-temporal parameters that quantifies the distance between the amount of variability observed in an asymptomatic reference group and the amount of variability observed in the patient. This index assesses gait instability and the risk of falling. It is usually high in children with CP.
Measured: At inclusion, then 3, 6 and 12 months later
Cycle width
Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation.
Measured: At inclusion, then 3, 6 and 12 months later
Anterior support of the foot during 1st double support
Ratio between the integrated pressure of the forefoot and the integrated pressure of the whole foot during the 1st double support. This variable will be higher the more the foot is supported on the ground by the forefoot, as in the PC child, and lower the more the foot is supported by the heel, as in the typically developing child.
Measured: At inclusion, then 3, 6 and 12 months later
Edinburgh walk visual score
Score developed for children with cerebral palsy, assessing the extent of kinematic deviations compared to typically developing children. (0 = normal, 1 = moderate or mild pathology, 2 = severe pathology). So 0 here means the best EVGS score.
Measured: At inclusion, then 3, 6 and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start25 Apr 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children With Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438432
- Sponsor's protocol ID
- 2023-A01969-36
- Acronym
- Activ'Tronc
- Status last verified
- Aug 2025
- First submitted
- 27 May 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zografou S, Pierret J, Vasa R, Paysant J, Beyaert C. Investigating rehabilitation by activities involving the trunk to improve balance and gait control in young children with cerebral palsy: A randomized open-label crossover trial protocol. PLoS One. 2026 Mar 13;21(3):e0334195. doi: 10.1371/journal.pone.0334195. eCollection 2026.
PubMed 41824540