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Active, Not Recruiting

NCT Number: NCT04568759

Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 10 and 16 years old,
  • Cobb angle between 15º and 45º,
  • Risser sign ≤3 (skeletal growth incomplete),
  • with a risk of progression index > 1.3,
  • having recent x-rays (4-6 weeks),
  • ability to travel weekly to attend GPR intervention

Exclusion criteria

  • patients with diagnosis other than AIS,
  • patients who are planned for surgery,
  • have had surgery,
  • worn a brace for at least three months prior to GPR intervention

Treatment and study plan

Global Postural Re-Education

Other

GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities

Primary outcomes

  1. Change in Cobb angle of at least 5 degrees

    Time frame: 6, 12 and 24 months

    Angle measured on radiograph for scoliosis progression

Secondary outcomes

  1. Back pain on the Numerical Pain Rating Scale

    Time frame: 6, 12 and 24 months

    Intensity of back pain on the Numerical Pain Rating Scale (0-10, where 0 indicates no pain et 10 the worst imaginable pain)

  2. Italian Spine Youth Quality of Life questionnaire

    Time frame: 6, 12 and 24 months

    Quality of life: score is between 0 and 100, where 100 represents a higher quality of life

  3. Trunk imbalance

    Time frame: 6 and 12 months

    The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm

  4. Diaphragm excursion

    Time frame: 6 and 12 months

    Diaphragm excursion using ultrasound imaging in mm

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • CHU de Québec
  • Laval University
  • Shriners Hospitals for Children
  • Université de Montréal

Registry information

Official study title

Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

Acronym: RCT-RPG

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 29, 2020
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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