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Scoliosis Specific Exercises for Adolescent Idiopathic Scoliosis (EX Trial)

N/A

Waitlist Available

Led By Karina Zapata, PhD

Research Sponsored by Texas Scottish Rite Hospital for Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

EX Trial Summary

This trial will compare the effects of scoliosis-specific exercises to the standard-of-care method for treating mild AIS curves in skeletally immature patients.

Eligible Conditions

Adolescent Idiopathic Scoliosis

EX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Home exercise adherence in the SSE group according to a smartphone application

Home exercise adherence in the SSE group according to weekly e-mails

Overall recruitment rate

+2 more

Secondary outcome measures

Brace prescription

Curve magnitude

Curve progression

EX Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physical Therapy Exercise GroupExperimental Treatment1 Intervention

Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions. Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer. Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.

Group II: Control GroupActive Control1 Intervention

Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.

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Find a Location

Who is running the clinical trial?

Boston Children's HospitalOTHER

761 Previous Clinical Trials

5,579,636 Total Patients Enrolled

Columbia UniversityOTHER

1,431 Previous Clinical Trials

2,460,739 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,259 Previous Clinical Trials

14,820,559 Total Patients Enrolled

Media Library

Scoliosis Specific Exercises Clinical Trial Eligibility Overview. Trial Name: NCT02807545 — N/A

Adolescent Idiopathic Scoliosis Research Study Groups: Physical Therapy Exercise Group, Control Group

Adolescent Idiopathic Scoliosis Clinical Trial 2023: Scoliosis Specific Exercises Highlights & Side Effects. Trial Name: NCT02807545 — N/A

Scoliosis Specific Exercises 2023 Treatment Timeline for Medical Study. Trial Name: NCT02807545 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are presently hosting this research project?

"Presently, six distinct medical sites are enrolling participants for this trial. The cities of Boston, Baltimore and Louisville offer convenient access to the research centres along with an additional 3 locations. To reduce travel difficulties, individuals should choose a centre closest to them."

Answered by AI

Who meets the criteria to participate in this healthcare research endeavor?

"This research study is recruiting 94 minors aged between 10 and 17 with a diagnosis of androgen-insensitivity syndrome. Candidates must also have major Cobb angle curvature measuring 12° to 24°, present a single thoracic, thoracolumbar or lumbar curve pattern, as well as being pre-pubertal (Risser Grade 0)."

Answered by AI

Are there any vacancies open to prospective participants in this trial?

"Clinicaltrial.gov confirms that this particular medical trial is now closed to recruitment, having first been listed on August 2nd 2016 and last edited on October 8th 2022. Nevertheless, there are currently 76 other clinical trials actively recruiting participants at the present time."

Answered by AI