CClinicalTrials.gg
Status unknownNCT03440749APP-PaCUpdated Oct 10, 2019

Rhythm and Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy

An interventional study of luminous stimuli in Cerebral Palsy, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-10.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
6 Years to 14 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • rhythm
  • serial Reaction Time Task
03

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
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

Exclusion Criteria:

For all children:

  • Children with a characteristic psychiatric pathology.
  • Disorders of the understanding
  • Hearing deficiency
  • Uncorrected visual impairment
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Children with Cerebral Palsy (PC)

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

    Other: luminous stimuli

  • Active comparator
    Control Group

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

    Other: luminous stimuli

Interventions

  • Otherluminous 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.

    Also known as: Serial reaction time task

05

What researchers measure

Primary outcomes

  1. Time reaction (TR)

    - 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.

    Time frame: 1 hour

Secondary outcomes

  1. Number of errors

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

    Time frame: 1 hour

Other outcomes

  1. Multisensory integration degree

    Multisensory integration degree evaluated in pre-test

    Time frame: 1 hour

  2. Degree of synchronization

    Degree of synchronization evaluated in pre-test

    Time frame: 1 hour

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03440749
Lead sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 15, 2018
Primary completion
Aug 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Oct 10, 2019

Study contacts

Philippe Marque, MD
Contact
marque.ph@chu-toulouse.fr
5-61-32-28-01 ext. 33
Isabelle OLIVIER, PhD
Contact
olivier.i@chu-toulouse.fr
561777051 ext. +33
Philippe Marque, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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