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

NCT ID: NCT06473363

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-03

Study Completion Date

2024-02-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy Balance Posture Disorders in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

1\) presence of rigid contracture in the trunk and lower extremities.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Seda AYAZ TAŞ

Assist. prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bolu Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BAIBU-SAT6

Identifier Type: -

Identifier Source: org_study_id

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