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Effect of Global Postural Re-education in Idiopathic Scoliosis

NCT ID: NCT03663088

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-03-01

Brief Summary

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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

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Conditions

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Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

GPR-A

Intervention Type OTHER

Standard Global postural re-education physiotherapy scoliosis specific exercises

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).

Group Type EXPERIMENTAL

GPR-B

Intervention Type OTHER

Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises

Interventions

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GPR-A

Standard Global postural re-education physiotherapy scoliosis specific exercises

Intervention Type OTHER

GPR-B

Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carole Fortin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carole Fortin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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StJustineH_CFortin

Identifier Type: -

Identifier Source: org_study_id