Multicenter Schroth Exercise Trial for Scoliosis
Multicenter Schroth Exercise Trial for Scoliosis
The primary aim of this multicenter randomized controlled trial is to compare the effect of a
 6 month "Schroth exercise program combined with standard-of-care" to "standard-of-care alone"
 on scoliosis curve severity measured using the Cobb angle.

 Secondary aims include:

 1. To determine the effect of Schroth exercises at 6 months on secondary outcomes including
 quality-of-life, spinal appearance, objective posture and spinal muscle endurance
 measurements.

 2. To determine the efficacy of 6 months of Schroth therapy offered to control participants
 after completing 6 months in the standard-of care group (using subjects as their own
 controls)

 3. To determine if the effects of the 6 months supervised Schroth exercise program can be
 maintained after supervised therapy is terminated.

 At Hopital Ste-Justine, the following secondary aims will be pursued to examine the
 preliminary evidence about the effect of Global Postural Re-education (to satisfy the local
 ethics committee request because Global Postural Re-education exercises were offered
 routinely to patients at that institution prior to the trial).

 A. To compare the effect and to quantify the treatment effect sizes of 6 months of "Global
 Postural Re-education exercises with North American standard Care consisting of only
 observation and bracing" to "Schroth exercises combined with North American standard care"
 and to "North American standard care alone" on scoliosis curve severity measured using the
 Cobb angle.

 B. To estimate the effect and quantify the treatment effect sizes of 6 months of "Global
 Postural Re-education exercises with North American standard Care" to "Schroth exercises
 combined with North American standard care" and to "North American standard care alone" on
 outcomes including quality-of-life, perceived spinal appearance, objective posture and spinal
 muscle endurance measurements.

 C. To determine if the effects of "Global Postural Re-education exercises with North American
 standard Care" can be maintained after discontinuing supervision.

 D. To estimate the feasibility of conducting a randomized trial focused on Global Postural
 Re-education exercises by quantifying enrollment rates, attendance at scheduled exercise
 sessions and compliance with the home exercises prescribed.
Multicenter Schroth Exercise Trial for Scoliosis (SETS study) Adolescent Idiopathic Scoliosis
 (AIS) is a progressive 3D deformity of the spine. It is the most common orthopedic condition
 in adolescents. Of those with curves larger than 10°, 90% are females. Scoliosis often
 results in chronic pain, poor posture, function, and self-image.

 Curves greater than 30° are braced or later surgically corrected. In Europe but not the
 Americas, small curves (<30°) are treated with exercises to prevent the need for bracing and
 moderate curves with bracing and exercises to prevent surgery. Bracing is uncomfortable and
 patients fear surgery. In contrast, exercises are generally well received.

 Schroth exercises are the most studied scoliosis exercises and have achieved very good
 outcomes. Schroth was the first exercise approach to offer formal certification training. No
 randomized controlled trial has focused on the Schroth method. Only 1 randomized controlled
 trial and only 3 prospective controlled studies with important methodological flaws were
 included in a recent review of the effect of all types of scoliosis exercises that found that
 exercises slowed the worsening of scoliosis. A randomized controlled trial on Schroth
 exercises is needed.

 Schroth exercises are asymmetric scoliosis-specific postural exercises and aim to improve the
 curve, posture, pain, function, and self-image. Schroth exercises target endurance and
 strength training of the abdominal, back, and leg muscles. Schroth exercises also aim to
 improve motor control of the posture by repeating corrective movements with progressively
 less feedback.

 Objectives: (1) To compare the effect of 6 month "of Schroth exercises combined with
 standard-of-care" to "standard-of-care alone" on scoliosis curve severity measured using the
 Cobb angle.

 Secondary aims include determining treatment effects on quality-of-life, spinal appearance,
 posture and spinal muscle endurance and monitoring if effect are maintained at long-term
 follow-ups.

 See above for objectives corresponding to the secondary analysis planned at Hopital
 Ste-Justine.

 Methodology:

 Participants: Two hundred fifty-eight females with AIS will be recruited for this study from
 our scoliosis clinic. Females 10-16 years old with curves 10° to 45°, and Risser less than or
 equal to 3 will be included. Patients who are planning surgery, have had surgery, worn a
 brace or to be discharged will be excluded.

 Procedures: Participants will be randomized to the standard-of-care group (observation of
 bracing if Boston brace criteria are met) or the Schroth exercise treatment group.

 (At hospital Ste-Justine, only because of the ethics committee requested we include a third
 trial arm, we will randomize an equal number of subjects to each of the three trial arms
 (Global Postural Re-education, Schroth and Standard care) using the a variable blocked
 randomization specific to this site. This implies recruiting an estimated additional 52
 patients to be randomized to the Global Postural Re-education group.) Outcomes will be
 measured by evaluators blind to randomization status at baseline and at 3 and 6 month
 follow-ups. The primary outcome is the spinal curvature angle on radiograph at 6 months.
 Secondary outcomes analyzed at 3, and 6 months include radiographs (Cobb angle, rotation),
 Scoliosis Research Society-22r quality-of-life domain scores (self-image, function, pain),
 spinal appearance questionnaire domain scores, postural measures (surface topography), and
 Sørensen back muscle endurance. Radiographs and Scoliosis Research Society-22 measures from
 routine scoliosis clinic visits will also be obtained from the clinic database until
 discharged from routine care. Measurement properties of all measures are adequate.

 Standard-of-care subjects will be under observation or treated with bracing if they meet the
 Scoliosis Research Society bracing criteria for 6 months and then be offered the Schroth
 exercise treatment as a recruitment incentive necessary based on our pilot. Treated patients
 will receive supervised and standardized Schroth exercises combined with a home program in
 addition to standard of care for 6 months. Parents will be involved to enhance (and monitor)
 compliance. (At hôpital Ste-Justine only, one group will receive the 6-month supervised
 Global Postural Re-education intervention consisting of individual training sessions with a
 therapist combined with a home exercise program consisting of 1 or 2 exercises to perform
 twice weekly in addition the standard of care).

 Analyses: Linear mixed models will be used to assess differences in group changes from
 baseline, to 3 months and 6-month, and adjusting for relevant covariates (including age, and
 risk of progression).

 Expected findings: Schroth exercises will improve curve characteristics, quality of life,
 posture, pain, and muscular endurance in patients with adolescent idiopathic scoliosis. The
 study team is integrated within the Edmonton scoliosis clinic, Montréal's Centre Hospitalier
 Universitaire Ste-Justine clinic and Calgary's Alberta Children Hospital Clinic. Research
 results can directly influence practice.
Inclusion Criteria:

 -  adolescent idiopathic scoliosis

 -  Females

 -  10° to 45° according to Cobb (scoliosis curve)

 -  with or without a brace

 -  ability to travel weekly to our lab

 -  skeletal maturity measured by Risser (0-3)

 Exclusion Criteria:

 -  other type of scoliosis

 -  patients with curves > 50°

 -  surgical candidates

 -  patients who have had a corrective spinal surgery

 -  out-of town candidates, without possibility to travel to our lab