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Enrolling by Invitation

NCT Number: NCT07516574

Pre-op Exercise for AIS Surgery

The goal of this clinical trial is to determine if pre-operative scoliosis-specific exercises have a beneficial effect on the health outcomes of surgery for adolescent idiopathic scoliosis. Adolescent idiopathic scoliosis affects adolescents between the age of 10-18.

The main questions this study aims to answer are:

* Can pre-operative exercises help reduce curve progression prior to surgery? * Can pre-operative exercises help improve the surgery outcomes, such as a lower number of vertebrae needing fusion, increased curve correction, reduced surgery length, and shorter length of stay in the hospital? * Can a pre-operative exercise intervention result in a reduction of the cost of surgery?

Researchers will compare the current standard of care (the control group) to an intervention group (with pre-op exercises) to see if pre-op exercises have an effect on these outcomes.

Participants will:

* visit the clinic every 3 months to complete ultrasound imaging scans and questionnaires * if given an exercise intervention, aim to complete it for roughly 30 minutes a day

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Science Building, University of Alberta

Edmonton, Alberta, T6G 2R8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of adolescent idiopathic scoliosis
  • aged 10 to 18
  • curve angle >40 degrees
  • waitlisted for posterior spinal fusion surgery at the Stollery Hospital

Exclusion criteria

  • previous surgeries
  • current use of scoliosis-specific exercises

Treatment and study plan

Pre-op Exercise Program

Behavioral

The pre-op exercise group will complete a 6-month supervised pre-op exercise program. This program is adapted from the Schroth exercise program we tested for moderate scoliosis, showing good effect on curve angles, muscle endurance, posture, curve severity, and in self-reported pain and QOL scores. This physiotherapy will individualize exercises to specific spinal curvature(s). Exercises will focus on elongating and derotating the spine to improve the flexibility before surgery. The corrective movements required, the targeted curve type, the level of passive support involved, and the dosages recommended, have been published previously. A Schroth curve classification algorithm and algorithms to guide the prescription for the curve type will help standardize treatment.

The program begins with 5 supervised visits in the first 2 weeks to help learn the exercises. The following month has supervised visits weekly and then every other week. The aim is to exercise 30mins per day 5x/week.

Primary outcomes

  1. Number of levels fused

    Time frame: Indicated during surgical planning, completed during surgery (where it may change from plans)

    The number of vertebrae levels fused during surgery for AIS. This is an indicator of the amount of flexibility afforded to participants post-op, their risk of adverse wear and tear on unoperated levels, and also can indicate significant cost savings to the hospital and health system.

Secondary outcomes

  1. Italian Spine Youth Quality of Life (ISYQOL) questionnaire

    Time frame: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

    The Italian Spine Youth Quality of Life questionnaire contains 20 questions with the first 13 answered by all patients with scoliosis and the next 7 answered only by those wearing a brace. The raw sum score of the items is converted to a 0 to 100 quality of life score where 100 indicates the best quality of life.

  2. Spinal Appearance Questionnaire (SAQ) v1.1 Appearance score

    Time frame: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

    The SAQ v1.1 is a questionnaire consisting of 14 items with the first 10 items producing an appearance score reflecting the self-perceived torso appearance. The appearance score ranges from 10 to 50 with low scores indicating better perceived appearance.

  3. Spinal Appearance Questionnaire (SAQ) v1.1 expectation score

    Time frame: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

    The SAQ v1.1 is a questionnaire consisting of 14 items with the last 4 items producing an expectation score reflecting the desire to be more even on some asymmetry features. The expectation score ranges from 4 to 20 with low scores indicating less desire to change the appearance.

  4. Spinal Appearance Questionnaire (SAQ) v1.1 total score

    Time frame: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

    The SAQ v1.1 is a questionnaire consisting of 14 items producing a score from 14 to 70 with low scores indicating better perceived appearance.

  5. Pre-operative flexibility measured by 3D Ultrasound Imaging

    Time frame: Baseline, 3 months, and 6 months

    The degree (amount) to which the frontal scoliotic curve is reduced during side-bending compared to standing in a radiograph or ultrasound imaging is the curve's flexibility. These will be taken in ultrasound scanning images of participants.

  6. Other Surgery-related Outcomes

    Time frame: During surgery & immediately post-surgery

    Other surgical outcomes include: length (duration) of surgery in minutes, length of stay in hospital post-surgery, percentage of curve correction.

  7. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. This consists of 14 individual questions that fall into a Breast (questions 4 a, b, c; 12; 13; 14) main domain. The TAASQ uses a combination of Likert scales and free text responses. Each multiple-choice question features answer options ranging from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

  8. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. This consists of 14 individual questions that fall into three main domains including the Clothing (1; 2 a, b, c, d, e; 3; 8 a, b, c; 9) domain. The TAASQ uses a combination of Likert scales and free text responses. Each multiple-choice question features answer options ranging from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

  9. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Appearance

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. This consists of 14 individual questions that fall into three main domains: including Appearance (5; 6; 7; 10; 11)., Each multiple-choice question features answer options ranging from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

  10. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast Location

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. The Breast domain can be categorized into a Breast location (Q4c, 13) subdomain scored from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

  11. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast shape

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. The Breast domain can be categorized into a Breast Shape (Q4b, 12) subdomain scored from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

  12. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast size

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. The Breast domain can be categorized into a Breast size (Q4a, 14). subdomain scored from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

  13. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing General

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. This consists of 14 individual questions that fall into a Clothing-General (Q1, 3, 8a, 9) subdomain. Each multiple-choice question features answer options ranging from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

  14. Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing Specific

    Time frame: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)

    The TAASQ assesses patient-perceived anterior truncal appearance. This consists of 14 individual questions that fall into a Clothing-Specific (Q2, 8b, 8c, 8d) subomain. Each multiple-choice question features answer options ranging from 1 to 5, where 5 corresponds to the least amount of concern or asymmetry and 1 corresponds to the most concern. The average score is then calculated for each domain and sub-domain. Higher scores on the TAASQ indicate better quality of life.

Sponsors and collaborators

Lead sponsor

Eric Parent

Other

Collaborators

  • Women and Children's Health Research Institute, Canada

Registry information

Official study title

Pre-operative Flexibility Exercises for Surgery for Adolescent Idiopathic Scoliosis

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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