Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT05878418
Eligibility Criteria:
Inclusion Criteria:
* 2-6 years old,
* Clinically and genetically diagnosed as Type I SMA,
* Having scoliosis (20-40 Cobb angle),
* Children who have not had any previous spinal surgery,
* Children who have received or continue to receive their medical treatments (nusinersen and onasemnogene abeparvovec).
Exclusion Criteria:
* Having acute respiratory failure and/or serious airway infections,
* 24-hour mechanical ventilation dependency,
* Continuing medical treatment in intensive care,
* Having other orthopedic and neurological problems,
* Children of parents who did not agree to participate in the study,
* Children whose chest expansion and/or oxygenation are at risk of being affected and who cannot tolerate the orthosis,
* Children and their parents who do not use the thoracolumbosacral spinal orthosis in accordance with the study protocol and do not comply with trunk exercises, pulmonary rehabilitation and pulmonary care practices.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT05878418
Study Brief:
Protocol Section:
NCT05878418