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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

NCT05691556 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-01-20

No results posted yet for this study

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

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691556 on ClinicalTrials.gov