Actively Recruiting

Phase Not Applicable
Age: 8Years +
All Genders
NCT07167927

Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

Led by University of Utah · Updated on 2025-12-05

110

Participants Needed

2

Research Sites

75 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this pilot hybrid type I efficacy/implementation trial is to assess a newly developed decision support tool patients, parents, and providers to use during surgical treatment decision making for neuromuscular scoliosis (NMS). Results from this pilot will inform the design of a future larger effectiveness trial of the decision support tool. Participants will either receive usual care or receive the decision support tool. Researchers will assess the decision made, decision quality, individual affective, cognitive, and behavioral effects, and feasibility and acceptability of tool use. They will also collect potential barriers and facilitators to implementation and feedback about the tool and study design to maximize likelihood of successful deployment of the tool into clinical practice and inform the design of a future trial. The outcomes measures will be used to inform potential effect size estimates to inform a future trial.

CONDITIONS

Official Title

Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

Who Can Participate

Age: 8Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Parent-child pairs where the child has neuromuscular scoliosis and both speak English or Spanish
  • Child is between 8 and 21 years old
  • Child is scheduled for a pediatric orthopedic surgery consultation about possible surgery for neuromuscular scoliosis
  • Neuromuscular scoliosis defined by neurologic impairment and scoliosis diagnoses or Pediatric Spine Study Group criteria
  • Pediatric orthopedic surgeons and neurosurgeons treating neuromuscular scoliosis at the study sites
Not Eligible

You will not qualify if you...

  • Child is younger than 8 years old at the time of orthopedic consultation
  • Child has Duchenne's or Becker's muscular dystrophy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

2

University of Utah

Salt Lake City, Utah, United States, 84114

Actively Recruiting

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Research Team

A

Angela Zhu, BS

CONTACT

M

Michelle Wilcox

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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