Skip to main content
OpenTrials
Completed

NCT Number: NCT06473363

Effectiveness of Ankle Foot Orhoses on Spinal Posture and Balance in Cerebral Palsy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

About this study

Cerebral palsy (CP) is defined as an umbrella term used as a group of permanent disorders of movement and posture development due to damage to the infant or fetus brain . CP shows a wide range of motor impairments including spasticity, muscle weakness, postural control deficits, and balance and gait disorders. These multifaceted motor limitations significantly affect the functional capacity of children with CP, limiting their participation in daily activities and significantly reducing their overall quality of life.

Poor motor control, abnormal biomechanical alignment, poor muscle activation, impaired agonist-antagonist muscle balance and balance disorders are the most common motor disorders in CP. Therefore, orthoses are prescribed in addition to rehabilitation for prevention and correction of deformities, improvement of postural control parameters, maintenance of correct muscle lengths.

The aim of this study was to investigate the effect of AFO use on spinal posture, balance and lower extremity functional skills in CP.

In this study, 25 Syrian children under temporary protection with spastic type CP were included. After obtaining permission from Abant Izzet Baysal University Clinical Research Ethics Committee (2022/339), informed consent was obtained from the children under temporary protection and their parents who volunteered to participate in the study. Inclusion criteria were as follows: 1) being diagnosed with spastic type CP between the ages of 6-18, 2) GMFCS level I, II or III, 3) using AFO for at least 3 months. All children were familiar with their AFO's. Exclusion criteria:1) presence of rigid contracture in the trunk and lower extremities. Demographic characteristics of the children (age, body weight, height, gender) were recorded.

Functionalities of the children were classified according to the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS) and Communication Function Classification System (CFCS). Spinal postures were evaluated with Spinal Mouse (SM), balance and lower extremity functional skills were evaluated with Paediatric Berg Balance Scale, Pediatric Functional Reach Test and Timed Up & Go Test. All these evaluations were repeated twice in children with AFO and barefoot. The evaluations were completed on two non-consecutive days. The results of both assessments were recorded and analysed.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Spinal posture

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

    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.

Secondary outcomes

  1. Balance

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

    Pediatric Berg Balance Scale (PBBS): The scale consists of 14 sections and each section is scored between 0-4; the highest score that can be obtained from the scale is 56.

  2. Dynamic balance

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

    Pediatric Functional Reach Test: It is a dynamic balance test in which the maximum distance that can be reached to the front and sides during standing upright posture is measured. The tape measure was placed on the wall at shoulder height in order to measure the distance reached

  3. Functional mobility

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

    Time up & Go Test (TUG): The activities that make up the test assess the transition from sitting to standing, walking, turning and sitting again, which are necessary for functional mobility and dynamic balance. The time required for the child to get up from a standard chair with armrests, walk a distance of 3 metres, turn from a designated or marked place, return to the chair and sit down again was measured in seconds

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

How the Use of Ankle Foot Orhoses Affects Spinal Posture and Balance in Children With Cerebral Palsy

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.