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

NCT ID: NCT05691556

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-16
• Study Completion Date: 2023-12-31

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).

Conditions

Cerebral Palsy Infantile

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Children CP

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

HABIT ILE rehabilitation course

Intervention Type: PROCEDURE

The HABIT-ILE course, created by the Belgian team of Prof. Yannick Bleyenheuft, is a rehabilitation of the upper and lower limbs, following the concepts of structured motor learning and intensive therapy. The internships last 2 weeks and are performed on a multi-year basis since 2018 at the SSR pediatric, Fondation Ildys, Site de Ty Yann in Brest.

In this group, upper limb assessments are performed the week before and the week after the HABIT ILE training course

botulinum toxin injections

Intervention Type: PROCEDURE

Toxin injections are used for their effect on the local reduction of spasticity after intramuscular injection. This treatment is usually offered to these children every 6 months or so for functional improvement.

These botulinum toxin injections are organized on a weekly basis in a pediatric day hospital (CHU Morvan in Brest).

In this group, upper limb assessments were performed 0-2 weeks before and then 4 to 6 weeks after the botulinum toxin injections (see table below), at the peak of the toxin's efficacy.

Interventions

HABIT ILE rehabilitation course

The HABIT-ILE course, created by the Belgian team of Prof. Yannick Bleyenheuft, is a rehabilitation of the upper and lower limbs, following the concepts of structured motor learning and intensive therapy. The internships last 2 weeks and are performed on a multi-year basis since 2018 at the SSR pediatric, Fondation Ildys, Site de Ty Yann in Brest.

In this group, upper limb assessments are performed the week before and the week after the HABIT ILE training course

Intervention Type: PROCEDURE

botulinum toxin injections

Toxin injections are used for their effect on the local reduction of spasticity after intramuscular injection. This treatment is usually offered to these children every 6 months or so for functional improvement.

These botulinum toxin injections are organized on a weekly basis in a pediatric day hospital (CHU Morvan in Brest).

In this group, upper limb assessments were performed 0-2 weeks before and then 4 to 6 weeks after the botulinum toxin injections (see table below), at the peak of the toxin's efficacy.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Brest

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marine Cacioppo

Role: CONTACT

marine.cacioppo@chu-brest.fr

02 98 02 11 36 ext. +33

Facility Contacts

Marine Cacioppo

Role: primary

marine.cacioppo@chu-brest.fr

Other Identifiers

29BRC21.0299 - BE API CHANGE

Identifier Type: -

Identifier Source: org_study_id