NCT06473363

Brief Summary

Background: Evidence on the effect of Ankle Foot Orthoses (AFO) on spinal posture which is very important for postural control, is insufficient.The aim of the study was to investigate the effect of AFO in spinal posture, balance and lower extremity functional skills in children with Cerebral Palsy (CP). Methods: This study was conducted using a repeated-measures design. 25 children with CP aged 6-17 years were included. Children were classified according to the Gross Motor Function Classification System (GMFCS), Manual Skills Classification System (MACS) and Communication Function Classification System (CFCS). Spinal postures with Spinal Mouse (SM), balance and lower extremity functional skills were evaluated using the Pediatric Berg Balance Scale, Pediatric Functional Reach and Timed Up \& Go Test twice with AFO and barefoot.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

4 years

First QC Date

June 7, 2024

Last Update Submit

June 23, 2024

Conditions

Keywords

Cerebral PalsyPostureSpinal mouseSpine

Outcome Measures

Primary Outcomes (1)

  • Spinal posture

    Spinal posture and mobility were evaluated with the Spinal Mouse in the standing position, placing weight on both lower extremities, as symmetrically as possible. By following the spinous processes paravertebrally on the skin surface, the device was moved from C7 to the anima rami (S3) and the information about the thorax, lumbar and sacrum/hip angles transferred to the computer via bluetooth was recorded. Measurements in the sagittal plane, standing upright, maximum trunk flexion and maximum trunk extension position; The measurements in the frontal plane were performed in 3 different positions as standing, right trunk lateral flexion and left trunk lateral flexion.

    Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 30 min

Secondary Outcomes (3)

  • Balance

    Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 15 min

  • Dynamic balance

    Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 5 min

  • Functional mobility

    Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 5 min

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

In this study, 25 Syrian children under temporary protection with spastic type CP were included.

You may qualify if:

  • being diagnosed with spastic type CP between the ages of 6-18,
  • GMFCS level I, II or III,
  • using AFO for at least 3 months.

You may not qualify if:

  • \) presence of rigid contracture in the trunk and lower extremities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. prof.

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 25, 2024

Study Start

January 3, 2020

Primary Completion

January 7, 2024

Study Completion

February 10, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations