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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03440749
Other study ID # RC31/17/0158
Secondary ID 2017-A01969-44
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2018
Est. completion date August 2020

Study information

Verified date October 2019
Source University Hospital, Toulouse
Contact Philippe Marque, MD
Phone 5-61-32-28-01
Email marque.ph@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 14 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Toulouse Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Multisensory integration degree Multisensory integration degree evaluated in pre-test 1 hour
Other Degree of synchronization Degree of synchronization evaluated in pre-test 1 hour
Primary 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. 1 hour
Secondary Number of errors The number of errors corresponds to pressing a key that does not correspond to the position of the lit square. 1 hour
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