Scoliosis-Specific Exercises for At-Risk AIS Curves
Scoliosis-Specific Exercises for At-Risk AIS Curves
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.
All patients with AIS meeting the following inclusion criteria will be eligible to
 participate in this trial: diagnosis of AIS; ages 10 to 17 years; major curve Cobb angles 15°
 to 20°; thoracolumbar, lumbar, or primary thoracic curve patterns; and Risser grade 0. Curves
 less than 15° will not be as clinically meaningful if they do not progress more than 5°.
 Curves 15° also allow for 5° of measurement error. Curves more than 20° will not be able to
 progress at least 5° before bracing is initiated according to SRS criteria (at 25°). Patients
 will be excluded according to the following exclusion criteria: scoliosis other than AIS,
 upper thoracic or double curve patterns, developmental disorders that prevent understanding
 and compliance with an exercise schedule, current or previous brace wear, and previous
 participation in a SSE program, previous spine surgery, inability to commit to performing a
 home exercise program for 15 minutes a day, 5 days a week, and inability to commit to attend
 at least 8 hours of PT within 6 months.

 Patient medical records will be reviewed for eligibility. If a patient is deemed eligible for
 inclusion in the study, a member of the research team will meet with the patient and his or
 her family to review the consent form in a private medical exam room. The family will be
 given ample time to review the consent form and ask any questions. If a participant chooses
 to participate, a consent form will be signed by both the patient and the legal guardian
 prior to any investigational procedures occurring. Once a consent form has been signed,
 patients will be randomly assigned by the TSRH on site statistician to one of the two
 following groups:

 1. Standardization of Physical Therapy:

 Physical therapists from Texas Scottish Rite Hospital, Boston Children's Hospital,
 Columbia University Medical Center, Norton Leatherman Spine Center, Johns Hopkins
 University, and Texas Children's Hospital who received training and certification in the
 Schroth-based (BSPTS) method have been recruited as members of the study team. Physical
 therapists at each institution will deliver a standardized exercise intervention.

 2. Study Groups:

 A) Scoliosis-Specific Exercise (SSE) 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:

 1. First session: 2 hours

 2. Session 2: 1 hour (1 week later)

 3. Session 3: 1 hour (1-2 weeks later)

 4. Session 4: 1 hour (2-3 weeks after Session 3)

 5. Session 5: 1 hour (3-4 weeks after Session 4)

 6. Session 6: 1 hour (1-2 months after Session 5)

 7. Session 7: 1 hour (1-2 months after Session 6)

 The exact number of training sessions and time frame will be determined by the patient's
 ability to perform the exercises. All therapists will use a standardized exercise
 prescription algorithm and performance checklist similar to Dr. Parent's Schroth scoliosis
 exercise study. Patients will perform a home exercise program for 15 minutes a day, 5 days a
 week, when they can independently execute their prescribed exercises according to the
 following criteria:

 1. Correctly move the pelvis so the body weight is over the base of support and neutral.

 2. Accurately set up exercises per curve pattern in different positions. Exercises progress
 from static to dynamic and passive to active corrections.

 3. Proficiently perform a minimum of 8 exercises integrating scoliosis-specific corrections
 which include auto-elongation to increase the spaces between the pelvis, vertebrae, and
 ribs. Various kinesthetic, mental imagery and proprioceptive strategies are used to
 further open concavities and depress convexities.

 4. Perform scoliosis-specific corrections during activities of daily living. The overall
 goal is for patients to maintain a corrective posture throughout the day.

 Patients will be asked to use a smartphone or tablet application (app) when performing the
 home exercise program which will be one method of tracking exercise adherence. A paper
 version of the app will be available to patients without access to a smartphone or tablet.

 Patients will also be sent electronically a weekly survey regarding home exercise adherence
 through a secure research database, the Research Electronic Data Capture (REDCap). 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.

 B) 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. Once
 all measurements have been collected at the patient's enrollment and one year followup,
 patients in this group will continue to be tracked through observation until skeletal
 maturity in order to record whether the patient experienced curve progression, was prescribed
 a brace, or proceeded to surgical treatment.
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 12° to 24°

 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