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Clinical Trials/NCT05691556
NCT05691556
Recruiting
Not Applicable

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

University Hospital, Brest1 site in 1 country20 target enrollmentJuly 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy Infantile
Sponsor
University Hospital, Brest
Enrollment
20
Locations
1
Primary Endpoint
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
Status
Recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 16, 2020
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 2 months

The Arm Profile score is a kinematic index that reflects the severity of the subject's movement deviation compared to the "normal" deviation of healthy children.

Secondary Outcomes

  • To study the association between the parameters measured in motion analysis clinical/functional measurements (kinematics and spatio-temporal parameters) before and after therapy.(2 months)
  • 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.(2 months)
  • 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).(2 months)
  • 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).(2 months)
  • 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.(2 months)

Study Sites (1)

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