NCT03468270

Brief Summary

The aim of the study is to describe pain coping strategies and their evolution in children and adolescent with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

March 12, 2018

Last Update Submit

March 16, 2018

Conditions

Cerebral PalsyPain

Outcome Measures

Primary Outcomes (1)

  • PPCI-F (Pediatric Pain and Coping inventory - French)

    Coping strategies used to face pain are measured by the French version of the PPCI. This scale leads to 4 subscores, corresponding to 4 different strategies.

    At inclusion

Secondary Outcomes (2)

  • SPQ (Structured Pain Questionnaire)

    At inclusion

  • Evolution of PPCI-F scores according to age.

    At inclusion

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The patients were recruited in the services of 2 French Red Cross Physical Medicine and Rehabilitation Centers in France. All parents and children were informed orally about the procedure, and parental consent as the child's consent was obtained in writing.

You may qualify if:

  • Confirmed diagnostic of cerebral palsy
  • GMFCS I, II, III, IV
  • Oral language skills with syntactic abilities

You may not qualify if:

  • Acute pain episode
  • severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Lyon, 69005, France

Location

MeSH Terms

Conditions

Cerebral PalsyPain

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 16, 2018

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 19, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)