NCT06531330

Brief Summary

High risk of infant is defined as an infant who has a history of negative environmental and biological factors and these factors can cause neuromotor development problems. This group is a heterogeneous group that includes premature babies born under thirty-seven weeks, term babies with low birth weight (LBW), or babies with developmental delays for various reasons. These infants are also monitored for Cerebral Palsy (CP). CP is the most common physical disability in childhood, with an incidence of 2.1 per 1000 births.In a 2017 clinical review of early diagnosis tools, a group of international experts published best practice recommendations, calling for early diagnosis to be made as a result of timely use of the recommended tools. The diagnosis of CP is typically made by a physician between 12 and 24 months of age, but in some cases it is delayed until 42 months.Correct and early use of the key tools required for early diagnosis may allow much earlier detection of CP for infants younger than 5 months or older.Early detection and monitoring of infants in the community for CP is essential only with appropriate, valid and reliable tools in order to minimize possible sequelae through timely implementation of CP-specific interventions. According to international guidelines, babies with high risk of CP should be followed up. This follow-up should be done by an interdisciplinary team such as neonatologist, pediatrician, pediatric neurologist, physiotherapist, speech-language-swallowing therapist, and special education specialist. Pediatric physiotherapists are an important part of this team in terms of developmental follow-up and rehabilitation. Therefore, it is important that the awareness level of pediatric physiotherapists in this field in our country is sufficient, they are equipped with various trainings and reach the international level. In this way, families at risk of CP can provide early guidance for their children, ensure early diagnosis of CP, and initiate treatment.The aim of this study is to evaluate the use of early diagnostic evaluation tools in at-risk of infants between the ages of 0-2 at risk of CP in pediatric physiotherapy practice in Turkey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

July 24, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

Cerebral PalsyEarly DetectiontoolsPediatric Physiotherapists

Outcome Measures

Primary Outcomes (1)

  • Digital survey

    Digital survey: Purpose-developed digital survey consisting of 45 multiple choice questions with 5 thematic sections. The survey to be used in this context will be a survey administered digitally to pediatric physiotherapists in Spain and translated into Turkish after obtaining the necessary permissions. This survey will be administered via Google forms.Pediatric physiotherapists working in different clinics will be asked to fill out a purpose-built electronic survey online. All survey questions will be delivered to physiotherapists electronically via social media (Whatsapp, Instagram, Facebook) or e-mail. Pediatric physiotherapists from at least 20 different provinces in Turkey will participate in this study. The survey measure will be assessed at the baseline of the study for one time.

    The baseline of the study for one time

Study Arms (1)

1

Pediatric physiotherapists working in Turkey

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Physiotherapists who have been working in the field of pediatric physiotherapy for at least 3 years and aged between 25-50 years old will be included in the study.Physiotherapists with any psychiatric diagnosis will be excluded.

You may qualify if:

  • \- Physiotherapists who have been working in the field of pediatric physiotherapy for at least 3 years

You may not qualify if:

  • Physiotherapists with any psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hatice Adiguzel, PhD PT

    Kahramanmaras Sutvu Imam University

    PRINCIPAL INVESTIGATOR
  • Bulent Elbasan, Proffessor

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 1, 2024

Study Start

March 1, 2023

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations