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 (BE API CHANGE)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Cerebral Palsy Infantile

Treatments: Procedure: botulinum toxin injections; Procedure: HABIT ILE rehabilitation course

Study type: Observational

Funder types: Other

Identifiers

NCT05691556

29BRC21.0299 - BE API CHANGE

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Children CP

Description:

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

Treatment:

Procedure: botulinum toxin injections

Procedure: HABIT ILE rehabilitation course