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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
luminous stimuli
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring rhythm, serial Reaction Time Task

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Children with Cerebral Palsy (PC)

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2018
Last Updated
October 9, 2019
Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03440749
Brief Title
Rhythm and Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy
Acronym
APP-PaC
Official Title
Rhythm and the Multisensoriality's Effects on the Motor Development in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
rhythm, serial Reaction Time Task

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparative monocentric physiopathological study with 2 groups of children : children with cerebral palsy and children age-matched for the control group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children with Cerebral Palsy (PC)
Arm Type
Experimental
Arm Description
Serial reaction time task: repeating a sequence of movements according to the luminous stimuli
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Serial reaction time task: of movements according to the luminous stimuli
Intervention Type
Other
Intervention Name(s)
luminous stimuli
Other Intervention Name(s)
Serial reaction time task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time reaction (TR)
Description
- 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 Outcome Measure Information:
Title
Number of errors
Description
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 Pre-specified Outcome Measures:
Title
Multisensory integration degree
Description
Multisensory integration degree evaluated in pre-test
Time Frame
1 hour
Title
Degree of synchronization
Description
Degree of synchronization evaluated in pre-test
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Marque, MD
Phone
5-61-32-28-01
Ext
33
Email
marque.ph@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle OLIVIER, PhD
Phone
561777051
Ext
+33
Email
olivier.i@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Marque, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31052
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Marque, MD
Phone
5-61-32-28-01
Ext
33
Email
marque.ph@chu-toulouse.frmarque.ph@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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