Clinical trial NCT05691556: Study of the Sensitivity to Change of a Bimanual 3D Analysis Protocol for the Assessment of Upper Limb Movement in Children With Cerebral Palsy Before and After Therapies
Official title: Study of the Sensitivity to Change of a Bimanual 3D Analysis Protocol for the Assessment of Upper Limb Movement in Children With Cerebral Palsy Before and After Therapies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy Infantile
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with cerebral palsy with motor impairment of the upper limb(s), seen in consultation and included in a HABIT-ILE therapeutic program and/or botulinum toxin injections.

Brief summary: Cerebral Palsy is the most common cause of motor disability in children. It can lead to a deficit of the upper limb which alters the realization of daily activities, in particular in bimanual situations, and eventually leads to a decrease in their participation.

Three-dimensional (3D) movement analysis is a tool that provides an accurate and objective measurement of movement. This technology allows us to understand and characterize movement anomalies in order to guide and adapt therapies to the upper limb. The majority of 3D upper limb analysis protocols used to measure the effect of interventions, such as botulinum toxin injections indicated for the treatment of spasticity or other innovative rehabilitative therapies, are unimanual and do not study bimanual function, which is more representative of the actual use of the upper limbs in daily life.

Recently, a 3D bimanual analysis protocol called "Be An Airplane Pilot" (BE-API), taking place in an innovative play context, has been developed and validated in PC children. The 2nd version of the protocol (BE API 2.0) also allowed the exploration of new parameters in a bimanual situation such as the fluidity and the trajectory of the movement. In order to determine the interest of the BE API 2.0 protocol in routine clinical evaluation of the upper limbs, its sensitivity to change, i.e. its capacity to detect modifications caused by a therapy on the movements of the upper limbs is necessary (e.g.: Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT ILE), botulinum toxin injections).


Eligibility criteria: Inclusion Criteria:

* Child between the ages of 5 and 18,
* Child with cerebral palsy as defined by the CSEP
* Level of manipulation sufficient to perform the tasks of the 3D protocol (MACS score I to III included),
* For whom the HABIT-ILE therapeutic program and/or botulinum toxin injection is prescribed
* Affiliated via his/her parents to a social security plan,
* No opposition formulated by the holders of parental authority and the child

Exclusion Criteria:

* Child with unilateral or bilateral spastic cerebral palsy
* Cognitive deficits hindering the comprehension of instructions or visual disorders not allowing the visualization of the game board,
* Pain in the upper limb (VAS score\>3),
* Contraindications to the use of botulinum toxins and absence of indications as mentioned in the HAS 2010 recommendations
* Patients under legal protection (guardianship, curatorship, ...)
* Refusal to participate

Primary outcomes:
measure: To study the sensitivity to change of the BE API 2.0 bimanual 3D analysis protocol by measuring the change in the severity of movement deviation in the upper limb before and after therapy
timeFrame: 2 months
Secondary outcomes:
measure: To measure the change induced by the therapy on the parameters measured in movement analysis (kinematic), clinical and functional measures at the deficient MS (comparison before and after therapy).
timeFrame: 2 months
measure: To measure the change induced by the therapy on the parameters measured in movement analysis (spatio-temporal), clinical and functional measures at the deficient MS (comparison before and after therapy).
timeFrame: 2 months
measure: To study the association between the parameters measured in motion analysis clinical/functional measurements (kinematics and spatio-temporal parameters) before and after therapy.
timeFrame: 2 months
measure: To study the association between the parameters measured in motion analysis with the BE API 2.0 protocol (kinematics and spatio-temporal parameters) before and after therapy.
timeFrame: 2 months
measure: Compare the dominant and non-dominant upper limb of PC children on parameters measured in motion analysis with the BE API 2.0 protocol (kinematic and spatio-temporal), before and after therapy.
timeFrame: 2 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References: