Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis

February 18, 2022 updated by: Halic University
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

288

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 34384
        • Recruiting
        • Rehabilitation Center
        • Contact:
          • Özge Ökçü, PT
          • Phone Number: 05365667200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
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.
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halic University

Collaborators

Medipol University
Istanbul Rumeli University

Investigators

  • Principal Investigator: Özge Ökçü, MSc., Istanbul Rumeli University
  • Principal Investigator: Hande Tunc, MSc., Halic University
  • Principal Investigator: Ahsen Buyukaslan, PhD.(c), Medipol University
  • Study Director: Hürriyet Yılmaz, Prof.Dr., Halic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

September 20, 2022

Study Completion (Anticipated)

September 26, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUEK96-28

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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