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Scoliosis-Specific Exercises for At-Risk AIS Curves (EX)

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ClinicalTrials.gov Identifier: NCT02807545
Recruitment Status : Unknown
Verified June 2016 by Texas Scottish Rite Hospital for Children.
Recruitment status was:  Enrolling by invitation
First Posted : June 21, 2016
Last Update Posted : November 16, 2016
Sponsor:
Collaborators:
Scoliosis Research Society
Boston Children’s Hospital
Columbia University
Norton Leatherman Spine Center
Johns Hopkins University
Texas Children's Hospital
University of Alberta Canada
Eric Parent
Dr. Daniel Sucato, MD
Dr. Michael Hresko, MD
Dr. Michael Vitale, MD
Dr. Steven Glassman, MD
Dr. Paul Sponseller, mD
Dr. John Dormans, MD
Information provided by (Responsible Party):
Texas Scottish Rite Hospital for Children

Brief Summary:
This study will be a multi-center, dual-arm randomized control study evaluating skeletally immature patients with mild AIS curves. At six institutions, patients will be randomized into either the scoliosis-specific exercise (SSE) treatment arm or a control group. The SSE group will receive training in SSE, posture, and activities of daily living by physical therapists certified in Schroth-based exercise methods. The control group will not receive SSE instruction and will only be observed by their treating orthopaedic surgeon (which is considered the standard-of-care treatment method). Results will be compared after one year of treatment.

Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Behavioral: Scoliosis Specific Exercises Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scoliosis-Specific Exercises for At-Risk Mild Adolescent Idiopathic Scoliosis Curves: A Multi-Site Preliminary Randomized Trial
Study Start Date : June 2016
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Therapy Exercise Group

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.

Behavioral: Scoliosis Specific Exercises
Other Name: Schroth-Based Method

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Recruitment rate at each site [ Time Frame: 1 year ]
    Measured by the number of participants enrolled per month at each site

  2. Overall recruitment rate [ Time Frame: 1 year ]
    Measured by the total number of participants enrolled.

  3. Treatment attendance in the SSE group [ Time Frame: 1 year ]
    Measured by the percentage of prescribed hours of physical therapy sessions attended

  4. Home exercise adherence in the SSE group according to weekly e-mails [ Time Frame: 1 year ]
    Measured by the percentage of prescribed exercises completed from baseline to 1 year

  5. Home exercise adherence in the SSE group according to a smartphone application [ Time Frame: 1 year ]
    Measured by the percentage of prescribed exercises completed from baseline to 1 year.


Secondary Outcome Measures :
  1. Curve magnitude [ Time Frame: Baseline and 1 year ]
    Measured by the Cobb angle on radiograph

  2. Curve progression [ Time Frame: after 1 year ]
    Measured by whether the curve progress >5 degrees

  3. Brace prescription [ Time Frame: after 1 year ]
    Measured by the percentage of participants prescribed a brace



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients diagnosed with Adolescent Idiopathic Scoliosis who meet the following inclusion criteria will be eligible to participate in this trial:

  1. Age 10 to 17 years
  2. Major curve Cobb angles of 15° to 20°
  3. Risser Grade 0
  4. Single thoracic, thoracolumbar, or lumbar curve patterns

Exclusion Criteria:

Patients will be excluded according to the following exclusion criteria:

  1. Scoliosis other than AIS (congenital, neuromuscular, etc)
  2. Upper thoracic or double curve patterns
  3. Diagnosis of a developmental disorder that prevents understanding and compliance with an exercise schedule
  4. Current or previous brace wear
  5. Previous participation in a SSE program
  6. Previous spine surgery
  7. Patient inability to commit to attend at least 8 hours of PT within 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807545


Locations
United States, Texas
Texas Scottish Rite Hospital for Children
Dallas, Texas, United States, 75219
Sponsors and Collaborators
Texas Scottish Rite Hospital for Children
Scoliosis Research Society
Boston Children’s Hospital
Columbia University
Norton Leatherman Spine Center
Johns Hopkins University
Texas Children's Hospital
University of Alberta Canada
Eric Parent
Dr. Daniel Sucato, MD
Dr. Michael Hresko, MD
Dr. Michael Vitale, MD
Dr. Steven Glassman, MD
Dr. Paul Sponseller, mD
Dr. John Dormans, MD

Responsible Party: Texas Scottish Rite Hospital for Children
ClinicalTrials.gov Identifier: NCT02807545     History of Changes
Other Study ID Numbers: 12-15-1203
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared in a de-identified fashion with the lead institution using generated study numbers

Keywords provided by Texas Scottish Rite Hospital for Children:
Scoliosis-Specific Exercises
Schroth

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases