Multicenter Schroth Exercise Trial for Scoliosis

NCT01610908 | Completed

• 1 other identifier: Pro00043397
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

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

Conditions

Scoliosis

Keywords

Adolescent; Idiopathic; Scoliosis; Schroth; Exercises; Conservative treatment

Outcome Measures

Primary Outcomes (1)

• Change in Cobb angle

  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.

  From baseline to 6 months

Secondary Outcomes (8)

• Change in Vertebral rotation

  Change from baseline to 6 months

• Change in Back muscle endurance

  From baseline, to 3 months and to 6 months follow-ups

• Change in Scoliosis Research Society-22r questionnaire scores

  From baseline, to 3 months and to 6 months follow-ups

• Change in Spinal Appearance Questionnaire scores

  From baseline, to 3, and to 6 months

• Global rating of change relative to baseline

  at 3 and at 6 months

Study Arms (3)

Schroth exercises

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

"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.

Global Postural Re-education (Montréal)

ACTIVE COMPARATOR

The active group (in Montréal only) receives the Global Postural Re-Education exercises treatment.Patients in this arm come to weekly individual 1 hour long therapy sessions where exercise prescription is adjusted. Selection of posture exercises is based on scoliosis type, on muscular chain stiffness associated with posture alterations and on position increasing scoliosis or pain (lying, sitting, standing). They they receive a 15-min home program consisting of 1 to 2 exercises to do at home everyday.

Other: Global Postural Re-Education

Interventions

The Schroth exercises treatment OTHER

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.

Also known as: Scoliosis specific exercises., The Schroth Approach.

Schroth exercises

Global Postural Re-Education OTHER

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.

Also known as: GPR, Ré-éducation posturale globale

Global Postural Re-education (Montréal)

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• adolescent idiopathic scoliosis
• Females
• ° 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Glenrose Foundation: collaborator
• Scoliosis Research Society: collaborator
• SickKids Foundation CIHR Institute of Human Development, Child and Youth Health: collaborator

Study Sites (3)

Alberta Children Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy

Edmonton, Alberta, T6G2G4, Canada

Location

CHU Ste-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (18)

• Watkins E, Bosnjak S, Parent E. Algorithms to prescribe Schroth exercises for each of four Schroth curve types. Scoliosis. 2012 Jan 27;7 Suppl 1:P22.

  BACKGROUND

• Schreiber S, Parent E, Watkins E, Hedden D. An algorithm for determining scoliosis curve type according to Schroth. Scoliosis. 2012 Jan 27;7 Suppl 1:O53.

  BACKGROUND

• Schreiber S, Parent EC, Hedden DM, Moreau M, Hill D, Lou E. Effect of Schroth exercises on curve characteristics and clinical outcomes in adolescent idiopathic scoliosis: protocol for a multicentre randomised controlled trial. J Physiother. 2014 Dec;60(4):234; discussion 234. doi: 10.1016/j.jphys.2014.08.005. Epub 2014 Oct 17.

  PMID: 25439713 BACKGROUND

• Schreiber S, Parent E, Khodayari Moez E, Hedden D, Hill D, Moreau M, Lou E, Watkins E, Southon S. (2016). Schroth Physiotherapeutic Scoliosis-specific exercises improve Cobb Angles in adolescents with Idiopathic Scoliosis - a randomized controlled trial.10th Annual WCHRI Research Day, Edmonton Canada, (oral 23 Page 27)

  BACKGROUND

• Schreiber S, Parent EC, Moez EK, Hedden DM, Hill D, Moreau MJ, Lou E, Watkins EM, Southon SC. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner". Scoliosis. 2015 Sep 18;10:24. doi: 10.1186/s13013-015-0048-5. eCollection 2015.

  PMID: 26413145 BACKGROUND

• Parent EC, Schreiber S, Hedden D, Moreau M. The effect of a 6-month Schroth exercise program: a pilot study using subjects as their own controls. Scoliosis. 2013;8(Suppl 2):045.

  RESULT

• Schreiber S, Parent EC, Hedden DM, Moreau M, Hill D, Watkins EM. The effects of a 6-month Schroth intervention for Adolescent Idiopathic Scoliosis (AIS): preliminary analysis of an ongoing randomized controlled trial. Scoliosis. 2013;8(Suppl 2):O44.

  RESULT

• Schreiber S, Parent E, Hedden D, Moreau MJ. Clinical Significance of The Effect of A Six-Months Schroth Exercise Intervention in Adolescents with Idiopathic Scoliosis. 2015 Annual Meeting Pediatric Orthopaedic Society of North America (POSNA), e-poster #18, p391, 2015

  RESULT

• Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Schroth physiotherapeutic scoliosis-specific exercises for adolescent idiopathic scoliosis: how many patients require treatment to prevent one deterioration? - results from a randomized controlled trial - "SOSORT 2017 Award Winner". Scoliosis Spinal Disord. 2017 Nov 14;12:26. doi: 10.1186/s13013-017-0137-8. eCollection 2017.

  PMID: 29164179 RESULT

• Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.

  PMID: 28033399 RESULT

• Schreiber S**, Parent EC, Hill DL, Hedden DM, Moreau M, Southon S. (2018). How much change in the Cobb angle is needed for the patients to observe positive change in their backs following a Schroth intervention? In Abstract Book Program from XIII International Meeting of the Society for Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT), Dubrovnik, Croatia, April 19-21, 2018, P71. (Winner of the 2018 SOSORT Award)

  RESULT

• Schreiber S*, Parent E, Hill D, Hedden D, Moreau M, Southon S. (2017). Schroth Physiotherapeutic Scoliosis-Specific Exercises for Adolescent Idiopathic Scoliosis: How Many Patients Require Treatment To Prevent One Deterioration?. Book of abstracts of the 12th International Meeting of the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment. Lyon, France, May 4 to 6 2017, O37.66, S7110-111

  RESULT

• Schreiber S*, Parent EC, Moez EK, Hedden DM, Hill D, Moreau M, Lou E, Watkins EM*, Southon SC. (2016). The effect of Schroth exercises added to the standard of care on the Cobb angle in adolescents with idiopathic scoliosis: An assessor and statistician blinded randomized controlled trial Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O60. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper O-81, pages 68-69

  RESULT

• Schreiber S*, Parent EC, Hedden DM, Hill DL Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O70. (2016). Minimal important differences in Scoliosis Research Society-22R, Spinal Appearance Questionnaire, Cobb angle and Biering-Sorensen back muscle endurance test following a six-month Schroth exercises intervention in adolescents with idiopathic scoliosis. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper 0-93, pages

  RESULT

• Parent EC, Schreiber S*, Moez EK, Preston S*, Hedden D, Moreau M, Hill D, Southon S, Watkins E*. (2016). Effects of Schroth exercises added to standard care in adolescents with idiopathic scoliosis (AIS) on surface topography parameters: A randomized controlled trial (RCT) Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O61. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper 0-82, page 69

  RESULT

• Parent EC, Ghaneei M*, Adeeb S, Schreiber S*, Moreau M, Hedden D, Hill D. (2016). Effects of Schroth exercises added to standard care in adolescents with idiopathic scoliosis (AIS) on marker-less surface topography asymmetry measurements: A randomized controlled trial (RCT) Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O62. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper 0-83, pages 69-70

  RESULT

• Schreiber S*, Parent E, Khodayari-Moez E, Hedden D, Hill D, Moreau M, Lou E, Watkins E*, Southon S. (2016). Schroth physiotherapeutic scoliosis-specific exercises improve Cobb angles in adolescents with idiopathic scoliosis - A randomized controlled trial. Proceedings of the 10th Annual WCHRI Research Day, Edmonton, Canada, November 16, 2016, Oral 23, page 27

  RESULT

• Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner. BMC Musculoskelet Disord. 2019 Jul 8;20(1):319. doi: 10.1186/s12891-019-2695-9.

  PMID: 31286903 DERIVED

MeSH Terms

Conditions

Scoliosis; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Eric C Parent, PT, MSc, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: June 4, 2012
• Study Start: April 1, 2011
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

CA (3)