Effectiveness of Ankle Foot Orhoses on Spinal Posture and Balance in Cerebral Palsy
How the Use of Ankle Foot Orhoses Affects Spinal Posture and Balance in Children With Cerebral Palsy
1 other identifier
observational
25
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
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
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2024
CompletedFirst Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedJune 25, 2024
June 1, 2024
4 years
June 7, 2024
June 23, 2024
Conditions
Keywords
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
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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