Cerebral PalsyNCT06473363
Effectiveness of Ankle Foot Orhoses on Spinal Posture and Balance in Cerebral Palsy
An observational study of Cerebral Palsy and Balance, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Balance, Posture Disorders in Children
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2020to 10 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Child, Adult
Study population: In this study, 25 Syrian children under temporary protection with spastic type CP were included.
Who may be able to join
- 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.
Who cannot join
- 1) presence of rigid contracture in the trunk and lower extremities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, 14030
About this study
Official title: How the Use of Ankle Foot Orhoses Affects Spinal Posture and Balance in Children With 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.
Read the 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.
- Conditions
- Cerebral Palsy, Balance, Posture Disorders in Children
- Keywords
- Cerebral Palsy, Posture, Spinal mouse, Spine
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 15 min
Dynamic balance
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
Measured: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 5 min
Functional mobility
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
Measured: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start3 Jan 2020
- Primary completion7 Jan 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473363
- Sponsor's protocol ID
- BAIBU-SAT6
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How the Use of Ankle Foot Orhoses Affects Spinal Posture and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06473363
- Acronym / sponsor ID
- BAIBU-SAT6
- Conditions
- Cerebral Palsy, Balance, Posture Disorders in Children
- Keywords
- Cerebral Palsy, Posture, Spinal mouse, Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- In this study, 25 Syrian children under temporary protection with spastic type CP were included.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) presence of rigid contracture in the trunk and lower extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Balance
Time frame: Measurements were made between the dates 07.01.2024-10.02.2024.The measurement of each individual took approximately 15 min
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Balance, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.