APP-PaC: Rhythm and Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Unknown status
CT.gov ID
NCT03440749
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
60
1
2
29.5
2

Study Details

Study Description

Brief Summary

Cerebral palsy (CP) affects the motor function but also the cognitive function of the child. Physical activity brings motor and cognitive benefits and appears as an important aspect of the therapy that is offered to them.

The child is seating in front of a computer, seating comfortably on a chair during 1 hour. The experimental task consists in learning a sequence of taps on "Serial reaction time task" type buzzers (SRTT) in which the child must press a buzzer corresponding to one of the 4 squares that on the screen. The sequence corresponds to 10 steps in a particular order.

Condition or Disease Intervention/Treatment Phase
  • Other: luminous stimuli
N/A

Detailed Description

Cerebral palsy (CP) affects the motor function but also the cognitive function of the child. Physical activity brings motor and cognitive benefits and appears as an important aspect of the therapy that is offered to them. In particular, the learning of movements in the presence of multisensory rhythmic information seems to have beneficial effects at the cognitive and motor level. The present study aims to test the respective effects of rhythm and multisensoriality on motor learning in children with cerebral palsy.

The motor learning task is known as the "Serial Reaction Time Task" (SRTT). It consists in repeating a sequence of movements of the upper limbs using visual-spatial information alone (V). It will test the addition of synchronous auditory stimulation to visual information or rhythmic auditory stimulation(VAR), to contrast with a control condition with non-rhythmic auditory stimulation (VANR). The performance of the children will be measured by the reaction time (RT), its stability and the number of errors made throughout the motor learning.

The child is placed in front of a screen on which 4 luminous stimuli are presented on a horizontal plane. Four buzzers are placed in front of him, each buzzer corresponds to the position of a stimulus. The stimuli light up in a predetermined sequence (10 positions) and the child must press the buzzer corresponding to the position of the stimulus that comes on. Four blocks of 5 sequences are repeated to test the general learning (B1 to B4) and then a block of random stimuli is presented to test the specific learning of the sequence (B5).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Comparative monocentric physiopathological study with 2 groups of children : children with cerebral palsy and children age-matched for the control groupComparative monocentric physiopathological study with 2 groups of children : children with cerebral palsy and children age-matched for the control group
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Rhythm and the Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy
Actual Study Start Date :
Feb 15, 2018
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Children with Cerebral Palsy (PC)

Serial reaction time task: repeating a sequence of movements according to the luminous stimuli

Other: luminous stimuli
The child is placed in front of a screen on which 4 luminous stimuli are presented on a horizontal plane. Four buzzers are placed in front of him, each buzzer corresponds to the position of a stimulus. Child had to push the buzzer corresponding to the place of the luminous stimuli.
Other Names:
  • Serial reaction time task
  • Active Comparator: Control Group

    Serial reaction time task: of movements according to the luminous stimuli

    Other: luminous stimuli
    The child is placed in front of a screen on which 4 luminous stimuli are presented on a horizontal plane. Four buzzers are placed in front of him, each buzzer corresponds to the position of a stimulus. Child had to push the buzzer corresponding to the place of the luminous stimuli.
    Other Names:
  • Serial reaction time task
  • Outcome Measures

    Primary Outcome Measures

    1. Time reaction (TR) [1 hour]

      - The TR is the Reaction Time between the appearance of the stimulus and the response. It represents the speed with which the child pressed the key in response to the lighting of the square.

    Secondary Outcome Measures

    1. Number of errors [1 hour]

      The number of errors corresponds to pressing a key that does not correspond to the position of the lit square.

    Other Outcome Measures

    1. Multisensory integration degree [1 hour]

      Multisensory integration degree evaluated in pre-test

    2. Degree of synchronization [1 hour]

      Degree of synchronization evaluated in pre-test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    For all children:
    • Age between 6 and 14 years

    • Obtaining the informed consent of the person possessing parental authority for all children

    For children with Cerebral Palsy:
    • Diagnosis of spastic cerebral palsy of levels GMFCS I to IV

    • Ability to press buzzers with the palm of the hand, Manual Ability Classification System (MASC) I to IV

    • Ability to understand instructions ("tap a buzzer along with a picture or sound") (investigator's appreciation)

    For control children: no pathology diagnosed

    Exclusion Criteria:
    For all children:
    • Children with a characteristic psychiatric pathology.

    • Disorders of the understanding

    • Hearing deficiency

    • Uncorrected visual impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Toulouse Toulouse France 31052

    Sponsors and Collaborators

    • University Hospital, Toulouse
    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    • Principal Investigator: Philippe Marque, MD, University Hospital, Toulouse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT03440749
    Other Study ID Numbers:
    • RC31/17/0158
    • 2017-A01969-44
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    Oct 10, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Toulouse
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2019