Clinical trial NCT06473363: Effectiveness of Ankle Foot Orhoses on Spinal Posture and Balance in Cerebral Palsy
Official title: How the Use of Ankle Foot Orhoses Affects Spinal Posture and Balance in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Balance
Posture Disorders in Children
Keywords: Cerebral Palsy
Posture
Spinal mouse
Spine
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, 25 Syrian children under temporary protection with spastic type CP were included.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Spinal posture
timeFrame: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 30 min
Secondary outcomes:
measure: Balance
timeFrame: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 15 min
measure: Dynamic balance
timeFrame: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 5 min
measure: Functional mobility
timeFrame: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 5 min
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
Study officials:
References: