Decision Support Tool for Scoliosis in Children

Recruiting at 1 trial location

Overseen By Michelle Wilcox

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Under 8, Duchenne's, Becker's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new decision support tool designed to assist families and doctors in making informed surgical choices for children with neuromuscular scoliosis, a spine condition linked to nerve or muscle issues. Participants will either use the tool or follow the usual care process. The researchers aim to assess the tool's impact on decision-making quality and collect feedback for future enhancements. Families with children aged 8-21 considering surgery for neuromuscular scoliosis and who speak English or Spanish may be suitable for this trial. As an unphased trial, it offers families the opportunity to contribute to the development of improved decision-making tools for future care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision support tool is safe for use in surgical treatment decision making for neuromuscular scoliosis?

Research has shown that decision support tools, like the one tested in this trial, are generally easy for people to use. These tools help patients and families make informed treatment choices, such as for scoliosis. Studies on similar tools in scoliosis care have demonstrated their effectiveness in assisting decision-making without causing harm.

These tools are usually software-based, like apps or websites, and do not directly affect the body. Instead, they provide information and guidance, making them very safe to use. Participants often find them helpful and easy to use, with no reports of negative experiences.

Since the decision support tool is non-invasive and doesn't involve medication or physical procedures, safety concerns are minimal. Feedback from users often highlights the tool's usefulness and clarity, rather than any risks. Therefore, based on available information, using such a tool is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Support Tool for scoliosis in children because it offers a new way to assist doctors and families in making informed treatment decisions. Unlike the current standard of care, which typically involves routine monitoring and possibly bracing or surgery, this tool provides personalized insights and recommendations based on the latest data and patient specifics. This innovative approach aims to optimize treatment outcomes and minimize unnecessary interventions, potentially transforming how scoliosis is managed in young patients.

What evidence suggests that this decision support tool is effective for neuromuscular scoliosis?

Research has shown that decision-making tools can be very useful in healthcare. For example, one study found that when parents received information, their ability to spot scoliosis in children improved from 68.8% to 74.0% accuracy. This finding suggests that having the right information can lead to better results. Additionally, ongoing research uses artificial intelligence (AI) to predict patient recovery after surgeries, potentially enhancing decisions about scoliosis treatments. In this trial, participants will receive either usual care or the novel decision support tool. While this specific tool is still being tested, similar methods have shown promise in improving decision quality and treatment outcomes. ^{3 6 7 8 9}

Who Is on the Research Team?

Jody Lin, MD, MS

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for children with neuromuscular scoliosis (NMS) who are facing decisions about surgical treatment. It's designed to help patients, parents, and healthcare providers make informed choices together.

Inclusion Criteria

All pediatric orthopaedic surgeons and neurosurgeons who treat neuromuscular scoliosis at study sites are eligible participants

My child is between 8-21 years old and may need surgery for NMS.

I am a parent of a child with neuromuscular scoliosis, and we speak English or Spanish.

Exclusion Criteria

My child has Duchenne's or Becker's muscular dystrophy.

My child with NMS is under 8 and needs orthopaedic surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either usual care or the decision support tool to aid in surgical treatment decision making for neuromuscular scoliosis

Immediately after clinic visit

1 visit (in-person)

Follow-up

Participants are monitored for decision quality, individual effects, and feasibility and acceptability of tool use

Within 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Decision Support Tool

Trial Overview

The study tests a decision support tool against usual care during the surgical treatment decision-making process for NMS. The focus is on measuring the quality of decisions made, emotional and cognitive impacts, and how well the tool works in practice.

How Is the Trial Designed?

Group I: Decision support tool Experimental Treatment 1 Intervention

Participants receive the novel decision support tool

Group II: Usual care Active Control 1 Intervention

Participants receive usual care

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07167927

Study Details | NCT07167927 | Developing an Innovative ...

The outcomes measures will be used to inform potential effect size estimates to inform a future trial. Detailed Description. Neuromuscular ...

2.

nature.com

nature.com/articles/s43856-024-00726-1

Predicting pediatric patient rehabilitation outcomes after ...

The goal of this study is to develop a planning and counseling support system for predicting how well patients recover after surgeries.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9025014/

Educating Parents Improves Their Ability to Recognize ...

This study showed that the education of parents improved their ability to detect scoliosis from 68.8% to 74.0%, without increasing the false ...

4.

shrinerschildrens.org

shrinerschildrens.org/en/news-and-media/news/2025/06/shriners-childrens-scoliosis-research-looks-for-breakthroughs-with-ai

Shriners Children's Scoliosis Research Looks For ...

Welborn's ongoing research will use AI to combine data from biologic, genomic and radiographic measures to predict growth patterns, skeletal ...

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pediatricsnationwide.org

pediatricsnationwide.org/2024/12/10/the-current-and-future-state-of-scoliosis-care-and-research/

The Current and Future State of Scoliosis Care and Research

Dr. Kadado says spinal motion analysis is becoming a larger focus in scoliosis research due to its implications on treatment decision making and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03017755

Scoliosis Survey to Development Treatment Decision Tool

This survey is designed to help understand the factors that families consider to help make treatment decisions related to Adolescent Idiopathic Scoliosis (AIS).

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10138677/

Scoliosis Management through Apps and Software Tools

This paper aims to provide an overview of the main features of the most popular scoliosis ICT tools, ie, apps and web-based applications for scoliosis ...

8.

fda.gov

fda.gov/media/187207/download?attachment

REFLECT (H210002) 2025 PAC Executive Summary

Based on OUS data supporting the implantation of two cords on the same curve (dual cord) or two scoliotic curves of the spine (double curve) across multiple ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11499369/

Applications of artificial intelligence for adolescent ...

Adolescent idiopathic scoliosis (AIS) is a common spinal deformity with varying progression, complicating treatment decisions.