Unilateral Spastic Cerebral Palsy Clinical Trial
— BE-APIOfficial title:
Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy
Verified date | February 2019 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | June 26, 2019 |
Est. primary completion date | June 26, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility |
Inclusion criteria : uCP children - Child aged from 6 to 17, - With Cerebral Palsy as defined by the SCPE, in unilateral spastic form. - Sufficient level of manipulation (MACS score from I to III) TDC children - Child aged from 6 to 17 Exclusion criteria : uCP children - Cognitive deficit altering the comprehension of the instructions or visual disturbances not allowing the visualization of the board game - Upper limb pain (EVA score> 3), - Botulinum toxin injections or upper extremity surgery in the 3 months before inclusion - Contraindication to the use of botulinum toxins and no indications as mentioned in the recommendations HAS 2010 TDC children - Visual disturbances not allowing the visualization of the board game - Upper limb pain (EVA score> 3), |
Country | Name | City | State |
---|---|---|---|
France | Rennes University Hospital | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | IPSEN, biopharmaceutical group (financial support), M2S lab |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome: Between-day reliability of kinematic parameters (MAX and ROM) will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC) and the Standard Measurement Errors (SEM) from the ICC. | Two kinematic parameters will be studied: MAX (Maximum angle value) and ROM (Range of Motion) parameters, measured in degrees. Outcome measures : Between-day reliability of MAX will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC). Between-day reliability of ROM will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC). From ICC, Standard Measurement Errors (SEM) can be calculated. SEM represents from how much degree, it can be considered that the fluctuation is unrelated to chance. |
At the end of the participation to the study for each uCP children (2- 4 weeks maximum) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03112434 -
Muscle Elastography in Spastic Cerebral Palsy
|