Schroth Exercise Trial for Scoliosis (SETS)
The primary aim of this 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:
- 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.
- 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)
- To determine if the effects of the 6 months supervised Schroth exercise program can be maintained after supervised therapy is terminated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial to Compare the Effect of Schroth Exercises to Standard Care on Curve Characteristics and Quality Of Life in Adolescents With Idiopathic Scoliosis|
- Change in Cobb angle [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]The angle from a posterior anterior full spine radiographs between the upper endplate of the upper end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.
- Change in Vertebral rotation [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]Using a posterior-anterior radiograph and a semi-automate algorithm in matlab the rotation of the most rotated vertebra in the curve will be extracted. The algorithm relies on the semi-automated identification of the position of the the pedicles vs the edges of the vertebral body.
- Change in Back muscle endurance [ Time Frame: From baseline, to 3 months and to 6 months follow-ups ] [ Designated as safety issue: No ]Using Sørensen back muscle endurance test, we record the time until fatigue to maintain the torso unsupported from the waist up horizontally against gravity with the arms crossed against the chest and the head and neck maintained aligned with the trunk. Leg are maintained firmly against the bed using gait belts tightened against a treatment table. The test stops if patients lose the ability to maintain the position after one reminder for good form or if they personally ask to stop because of pain or fatigue.
- Change in SRS-22r questionnaire scores [ Time Frame: From baseline, to 3 months and to 6 months follow-ups ] [ Designated as safety issue: No ]The SRS-22r questionnaire is available from SRS.org. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions. A total score is also available based on all 22 questions.
- Change in Spinal Appearance Questionnaire scores [ Time Frame: From baseline, to 3, and to 6 months ] [ Designated as safety issue: No ]
The SAQ measures patients' perception of their spinal deformity using standardized drawings and questions.
The new version of the SAQ containing 20 items will be used in this study, which addresses the following domains: General (items 9, 10, and 19), Curve (item 1), Prominence (items 2 and 3), Trunk shift (item 4 and 5), Waist (items 11, 12, and 13), Shoulders (items 6 and 16), Kyphosis (item 7), Chest (items 14 and 15) and Surgical scar (item 17). In scoring, we will use all domains, except Kyphosis and Surgical scar, because these domains are not relevant to the subjects in this study.
- Global rating of change relative to baseline [ Time Frame: at 3 and at 6 months ] [ Designated as safety issue: No ]A 15-point global rating scale will be used to assess the patient's perceived change over time. The scale ranges from -7 (a very great deal worse) to +7 (a very great deal better).
- Change in Self-efficacy [ Time Frame: From baseline, to 3 and to 6 months ] [ Designated as safety issue: No ]This questionnaire measures self-efficacy for overcoming barriers to physical activity (defined as corrective exercise activities) using 8 items rated from 1 (Disagree a lot) to 5 (Agree a lot).
- Change in numeric pain ratings and diagram [ Time Frame: From baseline, to 3 and to 6 months ] [ Designated as safety issue: No ]A scale from 0 (no pain) to 10 (worst imaginable pain) will assess current, best, worst pain intensity in the last 24 hours. A body pain diagram will help categorize the location of symptoms.
- Change in surface topography assessment of posture [ Time Frame: From baseline, to 3 and to 6 months ] [ Designated as safety issue: No ]
Four Laser Scanners are used to capture full-torso scans. Subjects are positioned in a standard frame, and 18 reference points marked. Parameters are extracted by digitizing 15 landmarks. Parameters quantifying the external back surface deformity are: decompensation, cosmetic score (combines the shoulder angle, scapula angle and waist asymmetry), in the coronal plane, the deformity in the axial plane index, Hump Sum, trunk twist in the transverse plane and kyphotic and lumbar angles in the sagittal plane.
From full torso scans are: lateral deviation of centroid, and back surface rotation.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Schroth exercises
The experimental group receives the Schroth exercises treatment.Patients in this arm receive 5 individual sessions with a Schroth therapist for introduction to the approach. They they receive a home program consisting of 3-4 exercises to do at home everyday for 30-45 minutes. They come to weekly group therapy sessions to where exercise prescription is adjusted.
Other: The Schroth exercises treatment
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 oer the span of 6 months.
No Intervention: Standard of care
"The Standard of care" is a control group that will continue receiving the standard North American treatment prescribed by a surgeon (observation or brace [if meeting SRS criteria]) for of 6 months. After 6 months, the participants will receive the Schroth exercises intervention for 6 months.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610908
|Contact: Eric C Parent, PhD, PTemail@example.com|
|Contact: Sanja Schreiber, MScfirstname.lastname@example.org|
|University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy||Recruiting|
|Edmonton, Alberta, Canada, T6G2G4|
|Contact: Eric C Parent, PhD 780-492-8889 email@example.com|
|Principal Investigator: Eric C Parent, PhD, PT|
|Principal Investigator:||Eric C Parent, PT, MSc, PhD||University of Alberta, Glenrose Rehabilitation Hospital|