Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening with Momentum SpineTM

Обзор

The goal of this clinical trial is for the Momentum SpineTM application to accurately detect scoliosis progression, including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs in 8-18 year olds with adolescent idiopathic scoliosis. The main question it aims to answer \[is/are\]: * Based on previous data it is hypothesize that Momentum SpineTM imaging software will be able to accurately detect scoliosis progression (\>= 7 degrees), including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs. * Based on the above hypothesis that Momentum SpineTM is able to accurately detect scoliosis and curve progression (\>= 7 degrees). * It is hypothesized there will be indications for accelerated clinical visits based on at home detection of progression, and that these visits will be accurate and necessary. * It is hypothesized that there will be a proportion of standard care visits that are deemed unnecessary, and that the application is able to accurately predict these visits. Participants will: * Use Momentum SpineTM assessment from home to perform body scans at 1-month intervals on personal device and during the clinical visit. * Received monthly scans that will be evaluated by the provider using the application. * Receive additional scans as warranted. * Complete net promoter score (NPS) within the application following completion of a body scan. * Complete a patient satisfaction survey following 6 months of application usage.

Вмешательства

• Устройство Momentum Application
  A mobile application to scan and predict spinal curvature. The application monitors curvature and track changes over time.

Первичные конечные точки

• Accuracy of Scoliosis Progression [Срок оценки: Immediately from enrollment and monthly through study completion]

Вторичные конечные точки (5)

• Proportion of follow-up visits that were correctly accelerated [Срок оценки: Immediately from enrollment through study completion, at an average of 2 years]
• Necessity of visit [Срок оценки: Immediately from enrollment and monthly through study completion]
• Proportion of avoidable x-rays using Momentum Spine [Срок оценки: Immediately from enrollment and monthly through study completion]
• Patient Satisfaction Survey [Срок оценки: Only at the 6 month visit]
• Net Promoter Score [Срок оценки: Immediately from enrollment and monthly through study completion]

Критерии участия

Критерии включения

• Children between the ages of 8-18 years of age
• Confirmed radiographic diagnosis of adolescent idiopathic scoliosis
• No history of spinal/ chest surgery.
• Participants who have had spine x-rays ±1 week as baseline visit at CHLA will be included in the study.
• Participants who have identifiable markings such as tattoos or birthmarks can be included in the study, though their markings will be covered with tape.

Критерии исключения

• Participants who have had x-rays in a brace will not be included.
• Participants who have had an x-ray from another institution will not be included in the study. X-rays from out of community are typically done with a different and lower quality machine then the one at our institution. Additionally, we do not have consent from outside institutions to use their x-rays for research purposes.
• Participants with a confirmed pregnancy will not be included. Pregnancy status will be self-reported by participants.
• Participants with the existence of a second deformity which may affect topographic assessment will be excluded (e.g. Limb length discrepancy greater than 2cm).
• Families who do not speak English and Spanish will be unable to participate as the application is only available in English and Spanish at this time.
• Families who do not have access to their own compatible personal smart phone device will be unable to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06825611 · CHLA-24-00371

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗