Schroth Exercise Trial for Scoliosis (SETS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by University of Alberta
Sponsor:
Collaborators:
Glenrose Rehabilitation Hospital Foundation
Scoliosis Research Society
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01610908
First received: April 2, 2012
Last updated: June 1, 2012
Last verified: May 2012
  Purpose

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:

  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.

Condition Intervention Phase
Scoliosis
Other: The Schroth exercises treatment
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.

Other Names:
  • Scoliosis specific exercises.
  • The Schroth Approach.
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

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adolescent idiopathic scoliosis
  • both genders
  • 10° to 45° according to Cobb (scoliosis curve)
  • with or without a brace
  • ability to travel weekly to our lab
  • all stages of skeletal maturity measured by Risser (0-5)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610908

Contacts
Contact: Eric C Parent, PhD, PT 780-492-8889 eparent@ualberta.ca
Contact: Sanja Schreiber, MSc 780-248-2064 sanja.schreiber@ualberta.ca

Locations
Canada, Alberta
University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy Recruiting
Edmonton, Alberta, Canada, T6G2G4
Contact: Eric C Parent, PhD    780-492-8889    eparent@ualberta.ca   
Principal Investigator: Eric C Parent, PhD, PT         
Sponsors and Collaborators
University of Alberta
Glenrose Rehabilitation Hospital Foundation
Scoliosis Research Society
Investigators
Principal Investigator: Eric C Parent, PT, MSc, PhD University of Alberta, Glenrose Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01610908     History of Changes
Other Study ID Numbers: Pro00011552
Study First Received: April 2, 2012
Last Updated: June 1, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Adolescent
Idiopathic
Scoliosis
Schroth
Exercises
Conservative treatment

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

ClinicalTrials.gov processed this record on July 22, 2014