Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473363
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2024-06-07
Brief Title:
Effectiveness of Ankle Foot Orhoses on Spinal Posture and Balance in Cerebral Palsy
Sponsor:
Abant Izzet Baysal University
Organization:
Abant Izzet Baysal University
Study Overview
Official Title:
How the Use of Ankle Foot Orhoses Affects Spinal Posture and Balance in Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Evidence on the effect of Ankle Foot Orthoses AFO on spinal posture which is very important for postural control is insufficientThe 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
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 2022339 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 AFOs Exclusion criteria1 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
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 2022339 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 AFOs Exclusion criteria1 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None