Neuromuscular ScoliosisNCT04764812
Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis
An observational study of Neuromuscular Scoliosis and Deformity, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Neuromuscular diseases caused by disruption of the normal conduction relationship between nerve system, neuromuscular junction, and muscles cause scoliosis as a secondary deformity. Neuromuscular scoliosis progresses due to muscle weakness and characteristic features of disease. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Neuromuscular Scoliosis, Deformity
- How many people
- 288 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 26 Sep 2022
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: -3-18 years patients who have neuromuscular scoliosis and various skeletal deformities due to neuromuscular disease or cerebral palsy.
Who may be able to join
- diagnosed with neuromuscular disease or cerebral palsy
- receiving treatment at a rehabilitation center in Istanbul
- willing to participate in the research and permitted by their caregiver
Who cannot join
- Spinal infections, tumors, trauma
- Trauma history of lower extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Rehabilitation Center
Istanbul, İ̇stanbul, 34384
Özge Ökçü, PT, 05365667200
About this study
Neuromuscular diseases caused by disruption of the normal conduction relationship between nerve system, neuromuscular junction, and muscles cause scoliosis as a secondary deformity. Neuromuscular scoliosis progresses due to muscle weakness and characteristic features of disease. The risk of complications associated with increased progression. Morbidity and mortality caused by scoliosis in neuromuscular diseases can be reduced by increasing the knowledge and awareness of the caregivers and physiotherapists. In this study, it was aimed to determine the risk of neuromuscular scoliosis and the factors which can cause in children with disabilities. It is also aimed to reveal inferences related to education levels, awareness of caregivers and professionals working in this field to determine cases with a high risk of scoliosis. Thus, it is expected to leading future research to develop preventive treatment approaches. For this purpose, 288 children who are diagnosed with the neuromuscular disease between 3-18 years of age, attending Rehabilitation Center in Istanbul and willing to participate in the research permitted by their caregiver will be included in this study. Cerebral Palsy Follow-Up Program (CPUP), Parents and Professionals Awareness Questionnaire related to Neuromuscular Scoliosis which is prepared by researchers, Early Onset Scoliosis 24 Questionnaire, Scoliosis Research Society 22 Questionnaire to assess QoL, demographic and clinical data also will collect for all sample. Patients will be examined for musculoskeletal system, scoliosis analysis will be performed radiologically. Data obtained to determine the problems, risk factors, and awareness of the caregivers and physiotherapists will be analyzed statistically.
- Conditions
- Neuromuscular Scoliosis, Deformity
- Keywords
- neuromuscular diseases, cerebral palsy, awareness, risk factors
- Medical subject headings
- Congenital Abnormalities, Neuromuscular Diseases, Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Palsy Follow-Up Program (CPUP) Assessment Form
Assessment form consisted pyhsical examination of pain, spasticity, range of motion, muscle strength, gross motor funtion stage, functional mobility, postural abilitis of patients in lying and sitting position, postural quality in sitting and standing position, screening spinal or other musculoskeletal deformities, assessment of orthotics, wheelchair or other mobility assistance if there is any that patients wearing/using.
Measured: baseline
Parents and Professionals Awareness Questionnaire related to Neuromuscular Scoliosis
Parents and professionals knowledge and approaches to the neuromuscular scoliosis, investigate their prevention strategies.The questionnaire developed by the researchers and doesn't have a scoring system meaning better or worse outcomes.
Measured: baseline
Early Onset Scoliosis 24 Questionnaire
The EOSQ-24 represents a subjective, parent-based, and self-report questionnaire. It includes 11 separate items in 24 questions. The domains are general health, pain, pulmonary function, mobility, physical function, daily living, fatigue, emotion, parental burden, financial burden, and satisfaction. Each question rated using a 5-point Likert scale. Total score obtain by adding domains. Higher scores indicates better qualitiy of life.
Measured: baseline
Scoliosis Research Society 22 Questionnaire
SRS-22 questionnaire was developed by SRS to evaluate health-related quality of life (HRQL) in patients with adolescent idiopathic scoliosis (AIS) and the Turkish version was validated in 2005. The SRS-22 questionnaire consists of 22 items Likert type scale that allows scoring between 1-5 for each question. SRS-22 has five domains including function, pain, mental health, self-image and satisfaction. Subgroups can be evaluated separately, or the total score is obtained by summing up the scores from all questions. The total score of each section ranges from 5 to 25, only the section evaluating satisfaction from the treatment is in the range of 2-10. Scoring is obtained by dividing the total score of each section by the number of questions in that section. Higher scores indicate better quality of life.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion20 Sep 2022 (estimated)
- Study completion26 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular ScoliosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University, Istanbul Rumeli University
- Responsible party
- Sponsor
- Investigators
- Özge Ökçü, MSc., Principal investigator, Istanbul Rumeli UniversityHande Tunc, MSc., Principal investigator, Halic UniversityAhsen Buyukaslan, PhD.(c), Principal investigator, Medipol UniversityHürriyet Yılmaz, Prof.Dr., Study director, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764812
- Sponsor's protocol ID
- HUEK96-28
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2021
- Last updated
- 21 Feb 2022
- 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 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis
- ClinicalTrials.gov ID
- NCT04764812
- Acronym / sponsor ID
- HUEK96-28
- Conditions
- Neuromuscular Scoliosis, Deformity
- Keywords
- neuromuscular diseases, cerebral palsy, awareness, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Medipol University, Istanbul Rumeli University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 26 Sep 2022 (estimated)
- First posted
- 21 Feb 2021 (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.
Neuromuscular diseases caused by disruption of the normal conduction relationship between nerve system, neuromuscular junction, and muscles cause scoliosis as a secondary deformity. Neuromuscular scoliosis progresses due to muscle weakness and characteristic features of disease. The risk of complications associated with increased progression. Morbidity and mortality caused by scoliosis in neuromuscular diseases can be reduced by increasing the knowledge and awareness of the caregivers and physiotherapists. In this study, it was aimed to determine the risk of neuromuscular scoliosis and the factors which can cause in children with disabilities. It is also aimed to reveal inferences related to education levels, awareness of caregivers and professionals working in this field to determine cases with a high risk of scoliosis. Thus, it is expected to leading future research to develop preventive treatment approaches. For this purpose, 288 children who are diagnosed with the neuromuscular disease between 3-18 years of age, attending Rehabilitation Center in Istanbul and willing to participate in the research permitted by their caregiver will be included in this study. Cerebral Palsy Follow-Up Program (CPUP), Parents and Professionals Awareness Questionnaire related to Neuromuscular Scoliosis which is prepared by researchers, Early Onset Scoliosis 24 Questionnaire, Scoliosis Research Society 22 Questionnaire to assess QoL, demographic and clinical data also will collect for all sample. Patients will be examined for musculoskeletal system, scoliosis analysis will be performed radiologically. Data obtained to determine the problems, risk factors, and awareness of the caregivers and physiotherapists will be analyzed statistically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- -3-18 years patients who have neuromuscular scoliosis and various skeletal deformities due to neuromuscular disease or cerebral palsy.
Key inclusion criteria (3 listed)
- diagnosed with neuromuscular disease or cerebral palsy
- receiving treatment at a rehabilitation center in Istanbul
- willing to participate in the research and permitted by their caregiver
Key exclusion criteria (2 listed)
- Spinal infections, tumors, trauma
- Trauma history of lower extremity
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
Cerebral Palsy Follow-Up Program (CPUP) Assessment Form
Time frame: baseline
Assessment form consisted pyhsical examination of pain, spasticity, range of motion, muscle strength, gross motor funtion stage, functional mobility, postural abilitis of patients in lying and sitting position, postural quality in sitting and standing position, screening spinal or other musculoskeletal deformities, assessment of orthotics, wheelchair or other mobility assistance if there is any that patients wearing/using.
Parents and Professionals Awareness Questionnaire related to Neuromuscular Scoliosis
Time frame: baseline
Parents and professionals knowledge and approaches to the neuromuscular scoliosis, investigate their prevention strategies.The questionnaire developed by the researchers and doesn't have a scoring system meaning better or worse outcomes.
Early Onset Scoliosis 24 Questionnaire
Time frame: baseline
The EOSQ-24 represents a subjective, parent-based, and self-report questionnaire. It includes 11 separate items in 24 questions. The domains are general health, pain, pulmonary function, mobility, physical function, daily living, fatigue, emotion, parental burden, financial burden, and satisfaction. Each question rated using a 5-point Likert scale. Total score obtain by adding domains. Higher scores indicates better qualitiy of life.
Scoliosis Research Society 22 Questionnaire
Time frame: baseline
SRS-22 questionnaire was developed by SRS to evaluate health-related quality of life (HRQL) in patients with adolescent idiopathic scoliosis (AIS) and the Turkish version was validated in 2005. The SRS-22 questionnaire consists of 22 items Likert type scale that allows scoring between 1-5 for each question. SRS-22 has five domains including function, pain, mental health, self-image and satisfaction. Subgroups can be evaluated separately, or the total score is obtained by summing up the scores from all questions. The total score of each section ranges from 5 to 25, only the section evaluating satisfaction from the treatment is in the range of 2-10. Scoring is obtained by dividing the total score of each section by the number of questions in that section. Higher scores indicate better quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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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.
Özge Ökçü, MSc. principal investigator
Istanbul Rumeli University
Hande Tunc, MSc. principal investigator
Halic University
Ahsen Buyukaslan, PhD.(c) principal investigator
Medipol University
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 Neuromuscular Scoliosis and Deformity, run by Halic 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 2 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özge Ökçü, MSc. (05365667200, ozge_okcu.92@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Palsy Follow-Up Program (CPUP) Assessment Form (time frame: baseline). The study lists 4 primary outcomes in all. 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 21 Feb 2022; AzTrials last refreshed its copy on 26 Oct 2026.