"Be an Airplane Pilot": A Bimanual 3D Motion Analysis in Children With Unilateral Cerebral Palsy

NCT03888443 | Completed

• 2 other identifiers: 35RC18_8849_BE-API2018-A03290-55
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Unilateral Spastic Cerebral Palsy

Keywords

Unilateral cerebral palsy; three-dimensional movement analysis; upper limb; bimanual task; bimanual performance

Outcome Measures

Primary Outcomes (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.

  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)

Study Arms (3)

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 "

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 "

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 "

Interventions

Bimanual 3D Motion Analysis " Be-API " DEVICE

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); uCP children; uCP children with botulinum toxin injections

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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),
• 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),

Sponsors & Collaborators

• Rennes University Hospital: lead
• M2S lab: collaborator
• IPSEN, biopharmaceutical group (financial support): collaborator

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

Related Publications (2)

• Cacioppo M, Lempereur M, Marin A, Rauscent H, Cretual A, Brochard S, Bonan I. Motor patterns of the impaired upper limb in children with unilateral cerebral palsy performing bimanual tasks. Clin Biomech (Bristol). 2022 Jul;97:105710. doi: 10.1016/j.clinbiomech.2022.105710. Epub 2022 Jun 22.

  PMID: 35763887 DERIVED

• Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.

  PMID: 33091791 DERIVED

Study Officials

• Isabelle bonan

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 25, 2019
• Study Start: February 13, 2019
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-02

Locations

FR (1)