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"Be an Airplane Pilot": A Bimanual 3D Motion Analysis in Children With Unilateral Cerebral Palsy (BE-API)

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ClinicalTrials.gov Identifier: NCT03888443
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
M2S lab
IPSEN, biopharmaceutical group (financial support)
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

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


Condition or disease Intervention/treatment
Unilateral Spastic Cerebral Palsy Device: Bimanual 3D Motion Analysis " Be-API "

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy
Actual Study Start Date : February 13, 2019
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
uCP children
15 Children aged from 6 to 17 with unilateral spastic Cerebral Palsy and a sufficient level of manipulation will realize the bimanual protocol twice separated from 2 to 4 weeks
Device: Bimanual 3D Motion Analysis " Be-API "

Movements will be measured using an optoelectronic system (12 cameras) which captures the displacement of 26 markers placed on the upper limbs and trunk of the child, according to the standards of the International Society of Biomechanics.

The child is installed on a chair and table height (equipment adapted and approved for pediatrics). A game board is installed in front of the child, with objects to handle, set and placed according to its anthropometry (joystick, steering wheel, buzzer, board, chip).


uCP children with botulinum toxin injections
5 children aged from 6 to 17 with unilateral spastic Cerebral Palsy and a sufficient level of manipulation will realize the bimanual protocol three times
Device: Bimanual 3D Motion Analysis " Be-API "

Movements will be measured using an optoelectronic system (12 cameras) which captures the displacement of 26 markers placed on the upper limbs and trunk of the child, according to the standards of the International Society of Biomechanics.

The child is installed on a chair and table height (equipment adapted and approved for pediatrics). A game board is installed in front of the child, with objects to handle, set and placed according to its anthropometry (joystick, steering wheel, buzzer, board, chip).


healthy volunteers (TDC children)
20 children aged from 6 to 17 (healthy volunteers) will realize the bimanual protocol once
Device: Bimanual 3D Motion Analysis " Be-API "

Movements will be measured using an optoelectronic system (12 cameras) which captures the displacement of 26 markers placed on the upper limbs and trunk of the child, according to the standards of the International Society of Biomechanics.

The child is installed on a chair and table height (equipment adapted and approved for pediatrics). A game board is installed in front of the child, with objects to handle, set and placed according to its anthropometry (joystick, steering wheel, buzzer, board, chip).





Primary Outcome Measures :
  1. 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. [ Time Frame: At the end of the participation to the study for each uCP children (2- 4 weeks maximum) ]

    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.




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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Children with unilateral spastic Cerebral Palsy and a sufficient level of manipulation followed in Physical Medicine and Rehabilitation in Rennes University Hospital
  • Safe volunteers will be recruited among children of the staff of the Rennes University Hospital (except children unit of Department of Physical Medicine and Rehabilitation) and the M2S laboratory.
Criteria

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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888443


Locations
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France
Rennes University Hospital
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
M2S lab
IPSEN, biopharmaceutical group (financial support)
Investigators
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Principal Investigator: Isabelle bonan Rennes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03888443    
Other Study ID Numbers: 35RC18_8849_BE-API
2018-A03290-55 ( Other Identifier: ANSM (French National Agency for Drugs) )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Unilateral cerebral palsy
three-dimensional movement analysis
upper limb
bimanual task
bimanual performance
Additional relevant MeSH terms:
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Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations