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

Children's Hospital Los Angeles

Status

Not yet enrolling

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Device: Momentum Application

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06825611

CHLA-24-00371

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.