Adolescent Idiopathic Scoliosis (AIS)
Conditions
Keywords
Adolescent idiopathic scoliosis, AIS, scoliosis, Schroth, flexibility
Brief summary
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
Interventions
BEHAVIORALPre-op Exercise Program
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.
Sponsors
Eric Parent
Women and Children's Health Research Institute (WCHRI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of levels fused | 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
| Measure | Time frame | Description |
|---|---|---|
| Italian Spine Youth Quality of Life (ISYQOL) questionnaire | 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. |
| Spinal Appearance Questionnaire (SAQ) v1.1 Appearance score | 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. |
| Spinal Appearance Questionnaire (SAQ) v1.1 expectation score | 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. |
| Spinal Appearance Questionnaire (SAQ) v1.1 total score | 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. |
| Pre-operative flexibility measured by 3D Ultrasound Imaging | 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. |
| Other Surgery-related Outcomes | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Appearance | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast Location | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast shape | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast size | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing General | 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. |
| Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing Specific | 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. |
Countries
Canada
Outcome results
None listed