Unilateral Spastic Cerebral Palsy Clinical Trial
Official title:
Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy
Cerebral Palsy, in particular in its unilateral spastic form (uCP), is the main cause of
motor disability in children, with a prevalence of 2/1000 births. These children have upper
limb motor impairments that hinder the realization of activities of daily life in bimanual
situations. 3D motion analysis (3DMA) is an objective and precise tool, considered as the
gold standard for gait analysis. The existing 3DMA protocols consist of movements too
standardized, in unimanual situations away from gestures of everyday life, or have not been
validated in bimanual situations.
In a preliminary study, a 3DMA bimanual protocol was study. it was composed of 4 tasks
integrated into a game scenario to have more spontaneity of movements, similar to those
experienced by children in daily life. It allows the exploration of all degrees of freedom of
the upper limb. Results showed an excellent acceptability and within day reliability on 20
uCP children and 20 typically developing children (TDC) for funct
This is a prospective study for evaluation of a diagnostic and therapeutic tool.
"Be An Airplane Pilot" 3DMA:
The protocol consists of 5 complementary bimanual tasks that are integrated into a scenario
game of "becoming an airplane pilot". It allows the exploration of all degrees of freedom of
the UL kinematics of the non-dominant/hemiplegic.
The protocol will take place in a session that corresponds to the driving of an airplane and
includes several tasks which consist of 5 repetitions of movements (= 5 cycles).
The kinematics of the trunk (flexion-extension, lateral flexions and rotations), shoulder
(elevation, plane of elevation, rotations), elbow (flexion-extension and pronosupination) and
wrist (flexion-extension and adduction/abduction) will be explored. The calculated kinematic
parameters are the range of motion (ROM) and the maximum angle (MAX) of the degrees of
freedom (DoF) of interest.
Group 1: uCP children without botulinum toxin injections
The 3DMA protocol will be performed in two sessions separated from 2-4 weeks to explore the
between day reliability in uCP children.
During the first session, this will be associated to physiotherapist and occupational
therapist evaluation in order to correlate kinematic parameters to clinical score. During the
first session, this will be associated to clinical assessment (muscle strength and tone,
pinch, grasp) by a physiotherapist and bimanual performance-based measures (Assisting Hand
Assessment (AHA) and Abilhand-kids) by an occupational therapist.
Group 2: uCP children with botulinum toxin injections
Five uCP children will perform the BE-API protocol before and after botulinum toxin
injections in the upper limb. This treatment is used for its effect on the local reduction of
spasticity after intramuscular injection. It is usually proposed to these children every 6-8
months.
Visit 1 is similar to Group 1 with 3DMA, occupational therapy and physiotherapy.
The second 3DMA will be done during the planned visit for toxin injections (2 to 4 weeks
after visit 1) and before treatment administration. Injections of botulinum toxins will be
followed by rehabilitation's intensification for 4 weeks (physiotherapy and home exercise)
according to the usual care of treated patients.
During Visit 3, 4 to 6 weeks after treatment by botulinum toxin injections, children will
have 3D analysis for the third time, with assessment in physiotherapy and occupational
therapy, comparable to the Visit 1.
Group 3: healthy volunteers (TDC children)
Their participation in the study will consist of a single visit, during which they will
realize the 3DMA protocol only.
Clinical measures
For uCP children, with or without toxin injections, descriptive characteristics such as age,
sex, hemiplegic side, as well as Manual Ability Classification System (MACS), Bimanual Fine
Motor Function (BFMF) and Modified House Classification will be collected in consultation.
The physiotherapy will do a clinical examination of the upper limbs: passive and active
measurement of the range of motion by goniometry, muscle strength, motor selectivity,
spasticity, grasp and pinch test, and sensitivity.
The evaluation of the bimanual performance will be carried out by a certified occupational
therapist with a validated scale: the Assisting Hand Assessment (AHA) and a questionnaire:
the Abiland-Kids (10) which will be filled with the parents
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03112434 -
Muscle Elastography in Spastic Cerebral Palsy
|