NCT05145231

Brief Summary

Cerebral palsy (CP) describes a group of persistent disorders in movement and postural development that cause activity limitation, attributed to non-progressive disturbances occurring in the developing fetal or infant brain. Motor disorders of cerebral palsy are often accompanied by sensory, perception, cognition, communication and behavioral disorders due to epilepsy and secondary musculoskeletal problems.(Rosenbaum et al. 2007) Within the ICF, body functions are the physiological functions of body systems and anatomical parts of the body, such as body structures, organs, limbs, and components. Disorders are problems that appear as a significant deviation or loss in body functions or structure. The primary injury in CP is a brain lesion resulting from an upper motor neuron lesion that is thought to have a number of positive and negative features. Positive traits include spasticity, hyperreflexia, and co-contraction, while negative traits include weakness, loss of selective motor control, and balance and coordination deficits. The aim of the study is to examine the validity and reliability of the Turkish version of the Functional Mobility Scale (FMS) in individuals with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

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

September 15, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

October 1, 2021

Last Update Submit

September 25, 2024

Conditions

Keywords

serebral palsiGMFCSFunctional Mobility ScaleAbiloco-kids

Outcome Measures

Primary Outcomes (1)

  • functional mobility scale

    6 points, Independent on all surfaces. It does not use any walking aids or require the assistance of another person when walking on all surfaces, including uneven floors. (sidewalks etc. and in a crowded environment.) 5 points, Independent on flat surfaces. Does not use walking aids or need someone else's help. It needs handrails for stairs. 4 points, uses a cane (one or two). Walks without the help of another person. 3 points uses crutches without someone else's help. 2 points use walker without anyone else's help. 1 point, Uses a wheelchair. Can stop for transfers, take a few steps assisted by another person or using a walker. C = Crawling: Child crawls (5m) to be able to move around the house. N = not valid : For example the child does not complete the distance ( 500 m ) .

    2 week

Study Arms (1)

grup 1

GMFCS PEDİ ABİLOCO-KİDS FMS

Other: observational

Interventions

The scales will be filled by asking the family.

grup 1

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 4-18 years diagnosed with cerebral palsy

You may qualify if:

  • to 18 years of age
  • Being diagnosed with cerebral palsy
  • The GMFCS level was determined to be between I-IV.

You may not qualify if:

  • The parent who will answer the form does not know Turkish.
  • Performing orthopedic surgery and botulinum toxin injection in the previous six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeni Kurtuluş Özel Eğitim Ve Rehabilitasyon Merkezi

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • saniye arslan

    kırıkkale üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

October 1, 2021

First Posted

December 6, 2021

Study Start

September 15, 2021

Primary Completion

April 30, 2022

Study Completion

May 20, 2022

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations