Clinical trial NCT04764812: Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis
Official title: Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuromuscular Scoliosis
Deformity
Keywords: neuromuscular diseases
cerebral palsy
awareness
risk factors
Lead sponsor: Halic University
Sponsor class: OTHER
Collaborators: name: Medipol University
name: Istanbul Rumeli University
First posted: 2021-02-21
Enrollment: 288
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -3-18 years patients who have neuromuscular scoliosis and various skeletal deformities due to neuromuscular disease or cerebral palsy.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Spinal infections, tumors, trauma
* Trauma history of lower extremity

Primary outcomes:
measure: Cerebral Palsy Follow-Up Program (CPUP) Assessment Form
timeFrame: baseline
measure: Parents and Professionals Awareness Questionnaire related to Neuromuscular Scoliosis
timeFrame: baseline
measure: Early Onset Scoliosis 24 Questionnaire
timeFrame: baseline
measure: Scoliosis Research Society 22 Questionnaire
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Rehabilitation Center
state: İ̇stanbul
Study officials:
affiliation: Istanbul Rumeli University
name: Özge Ökçü, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Halic University
name: Hande Tunc, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Ahsen Buyukaslan, PhD.(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Halic University
name: Hürriyet Yılmaz, Prof.Dr.
role: STUDY_DIRECTOR
References: