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Effect of Global Postural Re-education in Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT03663088
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Carole Fortin, St. Justine's Hospital

Tracking Information
First Submitted Date  ICMJE August 2, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Change in Cobb angle [ Time Frame: 6 and 12 months ]
Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Posture: shoulder elevation [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between a line drawn between the left and right coracoid process markers, and the horizontal: a decrease of this angle indicate improvement
  • Posture: right waist angle [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the cent Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the center of the waist to the lower end of the waist on the right side: more symmetry with the left side indicate improvement
  • Posture: left waist angle [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the cent Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the center of the waist to the lower end of the waist on the left side: more symmetry with the right side indicate improvement
  • Posture: thoracic scoliosis [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end-vertebra to the apex of the thoracic scoliosis curve and from the apex to the lower end-vertebra of the curve: decrease of this angle indicate improvement
  • Posture: lumbar scoliosis [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end-vertebra to the apex of the thoracolumbar or lumbar scoliosis curve, and from the apex to the lower end-vertebra of the curve: decrease of this angle indicate improvement
  • Posture: frontal trunk list [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The horizontal distance between C7 and a vertical line drawn from S1: decrease of this measure in millimeter indicate improvement
  • Posture: frontal pelvic tilt [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between the line joining the two anterior superior iliac spine (ASIS) and the horizontal: decrease of this angle indicate improvement
  • Posture: right sagittal pelvic tilt [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between the horizontal and the line joining the posterior superior iliac spine (PSIS) and ASIS on the right side: an angle between 20 and 30 degrees indicate a normal value and a better symmetry between right and left side indicate improvement
  • Posture: left sagittal pelvic tilt [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between the horizontal and the line joining the PSIS and ASIS on the left side: an angle between 20 and 30 degrees indicate a normal value and a better symmetry between right and left side indicate improvement
  • Posture: scapula asymmetry [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by a line drawn from the left and right inferior angles of the scapula and the horizontal: decrease of this angle indicate improvement
  • Change in back pain [ Time Frame: 6 and 12 months ]
    Change in the intensity (score) of back pain on the Numeric Pain Rating Scale score (0 no pain to 10 very important pain), lower value indicate improvement.
  • Change in score of The youth version of the Child & Adolescent Scale of Participation [ Time Frame: 12 months ]
    Change in score of The youth version of the Child & Adolescent Scale of Participation (CASP): The CASP questionnaire has 20 items x 4 levels from 1 (unable to participate) to 4 (age expected/full participation) with a maximum of 80 points. Higher value indicate improvement (better participation).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Posture: shoulder elevation [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between a line drawn between the left and right coracoid process markers, and the horizontal: a decrease of this angle indicate improvement
  • Posture: right waist angle [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the cent Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the center of the waist to the lower end of the waist on the right side: more symmetry with the left side indicate improvement
  • Posture: left waist angle [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the cent Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the center of the waist to the lower end of the waist on the left side: more symmetry with the right side indicate improvement
  • Posture: thoracic scoliosis [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end-vertebra to the apex of the thoracic scoliosis curve and from the apex to the lower end-vertebra of the curve: decrease of this angle indicate improvement
  • Posture: lumbar scoliosis [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end-vertebra to the apex of the thoracolumbar or lumbar scoliosis curve, and from the apex to the lower end-vertebra of the curve: decrease of this angle indicate improvement
  • Posture: frontal trunk list [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The horizontal distance between C7 and a vertical line drawn from S1: decrease of this measure in milimeter indicate improvement
  • Posture: frontal pelvic tilt [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between the line joining the two ASIS and the horizontal: decrease of this angle indicate improvement
  • Posture: right sagittal pelvic tilt [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between the horizontal and the line joining the PSIS and ASIS on the right side: an angle between 20 and 30 degrees indicate a normal value and a better symmetry between right and left side indicate improvement
  • Posture: left sagittal pelvic tilt [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed between the horizontal and the line joining the PSIS and ASIS on the left side: an angle between 20 and 30 degrees indicate a normal value and a better symmetry between right and left side indicate improvement
  • Posture: scapula asymmetry [ Time Frame: 6 and 12 months ]
    Clinical Photographic Postural Assessment Tool: The angle formed by a line drawn from the left and right inferior angles of the scapula and the horizontal: decrease of this angle indicate improvement
  • Changein in back pain [ Time Frame: 6 and 12 months ]
    Change in the intensity (score) of back pain on the Numeric Pain Rating Scale score (0 no pain to 10 very important pain), lower value indicate improvement.
  • Social participation [ Time Frame: 12 months ]
    Change in score of The youth version of the Child & Adolescent Scale of Participation (CASP): The CASP questionnaire has 20 items x 4 levels from 1 (unable to participate) to 4 (age expected/full participation) with a maximum of 80 points. Higher value indicate improvement (better participation).
Current Other Pre-specified Outcome Measures
 (submitted: September 7, 2018)
  • Recruitment rate [ Time Frame: 12 months ]
    Percentage of eligible patients recruited: 70% of participants recruited indicate good recruitment rate
  • Completion rate [ Time Frame: 12 months ]
    Percentage of recruited participants who completed the trial: 75% of completion indicate good completion rate
  • Adherence (compliance) with GPR treatment in terms of collaboration, presence and implication in home exercises [ Time Frame: 12 months ]
    Adherence with GPR treatment will be measured by the physiotherapists using the validated 3-item Sport Injury Rehabilitation Adherence Scale (SIRAS, were total score varies from 3 (low adherence) to 15 (high adherence)). We will also compute presence/absence to therapy and we will use a patient/parent logbook for home exercises. Good adherence (compliance) to treatment will be achieved if a participant has a score of at least 12 out of 15 on the SIRAS 80 % of the treatment sessions, is present to therapy 80% of the sessions and completes home exercises 80% of the time.
Original Other Pre-specified Outcome Measures
 (submitted: September 5, 2018)
  • Recruitment rate [ Time Frame: 12 months ]
    Percentage of eligible patients recruited: 70% of participants recruited indicate good recruitment rate
  • Completion rate [ Time Frame: 12 months ]
    Percentage of recruited participants who completed the trial: 75% of completion indicate good completion rate
  • Adherence [ Time Frame: 12 months ]
    Collaboration to treatment: 80% of collaboration indicate good adherence
 
Descriptive Information
Brief Title  ICMJE Effect of Global Postural Re-education in Idiopathic Scoliosis
Official Title  ICMJE Pilot Study for a Randomized Controlled Clinical Trial on the Effect of Global Postural Re-education in the Treatment of Idiopathic Scoliosis: a Feasibility Study
Brief Summary In North America, children and adolescents with idiopathic scoliosis (IS) are rarely referred for a rehabilitation program whereas the European guidelines stated that scientific evidences concerning scoliosis specific physiotherapy exercises were strong enough to recommend the use of these exercises at an early stage. The objectives of this pilot study is to assess feasibility of conducting a larger randomized control trial (RCT) on the effect of global postural re-education (GPR) on scoliosis progression (Cobb angle) and posture, back pain and participation and to assess the equivalence of two groups of GPR interventions. A convenience sample of 60 adolescents with IS (Cobb angle 15º-50º, Risser sign ≤3) will be recruited at CHU Sainte-Justine. Participants will be randomly allocated to GPR-A (individual sessions once a week) or GPR-B (individual sessions once per two weeks alternately with class exercises once per two weeks) for 6 months. After 6 months, groups will be interchanged for another 6 months. Feasibility outcomes will be recruitment rate, consent rate, completion rate and adherence to treatment at 12 months. The primary outcome of the effect of GPR will be the Cobb angle. Secondary outcomes will be: posture, back pain and participation at 6 and 12 months. Statistical analyses: For feasibility, percentage of eligible patients recruited, percentage of recruited patients who completed the trial and adherence to treatment will be calculated. For the preliminary effects of GPR, linear mixed-models will be used to assess differences in groups' changes from baseline, to 6 and 12-month while adjusting for covariates (age, Risser, adherence). Separate analyses will be conducted for each outcome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Scoliosis
Intervention  ICMJE
  • Other: GPR-A
    Standard Global postural re-education physiotherapy scoliosis specific exercises
  • Other: GPR-B
    Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises
Study Arms  ICMJE
  • Active Comparator: GPR-A
    The 6-months supervised GPR-A group will receive a 1-hour-long individual session once a week plus a home program (1 or 2 exercises, 2 times a week).
    Intervention: Other: GPR-A
  • Experimental: GPR-B
    The 6-months supervised GPR-B group will receive a 1-hour long individual session once per two weeks alternately with a 1-hour-long class of exercises once per two weeks plus a home program (1 or 2 exercises, 2 times a week).
    Intervention: Other: GPR-B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged between 8 and 16 years old,
  • Cobb angle between 15º and 50º,
  • a Risser sign ≤3 (skeletal growth incomplete),
  • having recent x-rays (4-6 weeks),
  • ability to travel weekly to attend GPR interventions

Exclusion Criteria:

  • patients who are planning surgery or have had surgery,
  • previous regular physiotherapy or other conservative treatment (chiro, osteopathy),
  • worn a brace for at least three months prior to GPR interventions,
  • scheduled for clinic follow-up later than in 6±2 months,
  • or to be discharged before 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carole Fortin, Ph.D. 5143741710 ext 8136 carole.fortin@umontreal.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03663088
Other Study ID Numbers  ICMJE StJustineH_CFortin
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Carole Fortin, St. Justine's Hospital
Study Sponsor  ICMJE St. Justine's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carole Fortin, Ph.D. St. Justine's Hospital
PRS Account St. Justine's Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP