- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03440749
Rhythm and Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy (APP-PaC)
Rhythm and the Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Toulouse, France, 31052
- Recruiting
- University Hospital Toulouse
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Contact:
- Philippe Marque, MD
- Phone Number: 33 5-61-32-28-01
- Email: marque.ph@chu-toulouse.frmarque.ph@chu-toulouse.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children with Cerebral Palsy (PC)
Serial reaction time task: repeating a sequence of movements according to the 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:
|
|
Active Comparator: Control Group
Serial reaction time task: of movements according to the 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time reaction (TR)
Time Frame: 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.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of errors
Time Frame: 1 hour
|
The number of errors corresponds to pressing a key that does not correspond to the position of the lit square.
|
1 hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multisensory integration degree
Time Frame: 1 hour
|
Multisensory integration degree evaluated in pre-test
|
1 hour
|
|
Degree of synchronization
Time Frame: 1 hour
|
Degree of synchronization evaluated in pre-test
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe Marque, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/17/0158
- 2017-A01969-44 (Other Identifier: Toulouse Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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