Multicenter Schroth Exercise Trial for Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): The Schroth exercises treatment; Global Postural Re-Education
Intervention type(s): Other; Other
Intervention description(s): The Schroth approach consists of 3D scoliosis-specific exercises based on sensorimotor and kinesthetic principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. To achieve this goal, Schroth exercises focus on endurance and strength training of postural muscles. Schroth exercises also aim to improve posture motor control by repeating corrective movements with progressively less feedback and less passive support.
Dosage: 5 individual 1-hour long sessions, continued with the daily 45 minutes home exercise program. In addition, patients are required to come weekly for 1-hour long group sessions over the span of 6 months.; The 6-month supervised Global Postural Re-education intervention involves active movements and postures aimed at realigning joints, stretching shortened muscles and enhancing the contraction of antagonist muscles, thus avoiding postural asymmetry. These postures imply an active participation of the patient. Global Postural Re-education includes eight therapeutic postures, lying, sitting or standing, held for 15/20 min. each. Variously combinations are used during sessions chosen on based on the amount of pain, load capacity, age of the patient, and muscle chains to be stretched. Static and dynamic functions are also employed for about five minutes each sessions to use the recovered flexibility in functional activities Dosage: Weekly individual 1-hour long sessions, with daily 15 minutes home exercise program over 6 months.
Other intervention name(s): Scoliosis specific exercises.; The Schroth Approach.; GPR; Ré-éducation posturale globale
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent; Idiopathic; Scoliosis; Schroth; Exercises; Conservative treatment