NCT03440749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2.5 years

First QC Date

February 13, 2018

Last Update Submit

October 9, 2019

Conditions

Cerebral Palsy

Keywords

rhythmserial Reaction Time Task

Outcome Measures

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.

    1 hour

Secondary Outcomes (1)

  • Number of errors

    1 hour

Other Outcomes (2)

  • Multisensory integration degree

    1 hour

  • Degree of synchronization

    1 hour

Study Arms (2)

Children with Cerebral Palsy (PC)

EXPERIMENTAL

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

Other: luminous stimuli

Control Group

ACTIVE COMPARATOR

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

Other: luminous stimuli

Interventions

luminous stimuliOTHER

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
Children with Cerebral Palsy (PC)Control Group

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • For all children:
  • Children with a characteristic psychiatric pathology.
  • Disorders of the understanding
  • Hearing deficiency
  • Uncorrected visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31052, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Philippe Marque, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Marque, MD

CONTACT

5-61-32-28-01marque.ph@chu-toulouse.fr

Isabelle OLIVIER, PhD

CONTACT

561777051olivier.i@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Comparative monocentric physiopathological study with 2 groups of children : children with cerebral palsy and children age-matched for the control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 22, 2018

Study Start

February 15, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)