Pre-op Exercise for AIS Surgery

Официальное название

Pre-operative Flexibility Exercises for Surgery for Adolescent Idiopathic Scoliosis

Обзор

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

Вмешательства

• Поведенческое Pre-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 m

Первичные конечные точки

• Number of levels fused [Срок оценки: Indicated during surgical planning, completed during surgery (where it may change from plans)]

Вторичные конечные точки (12)

• Italian Spine Youth Quality of Life (ISYQOL) questionnaire [Срок оценки: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)]
• Spinal Appearance Questionnaire (SAQ) v1.1 Appearance score [Срок оценки: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)]
• Spinal Appearance Questionnaire (SAQ) v1.1 expectation score [Срок оценки: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)]
• Spinal Appearance Questionnaire (SAQ) v1.1 total score [Срок оценки: Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)]
• Pre-operative flexibility measured by 3D Ultrasound Imaging [Срок оценки: Baseline, 3 months, and 6 months]
• Other Surgery-related Outcomes [Срок оценки: During surgery & immediately post-surgery]
• Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast [Срок оценки: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)]
• Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Clothing [Срок оценки: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)]
• Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Appearance [Срок оценки: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)]
• Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast Location [Срок оценки: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)]
• Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast shape [Срок оценки: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)]
• Truncal Anterior Asymmetry Scoliosis Questionnaire (TAASQ) Breast size [Срок оценки: Baseline, 3 months, 6 months, and first routine follow-up post-surgery (6 weeks post-op)]

Критерии участия

Критерии включения

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

Критерии исключения

• previous surgeries
• current use of scoliosis-specific exercises

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Clinical Science Building, University of Alberta — Edmonton

Публикации

• Calman R, Smithers T, Rowan R. Impact of surgical waiting time on paediatric spinal deformity patients. ANZ J Surg. 2013 Dec;83(12):929-32. doi: 10.1111/ans.12196. Epub 2013 May 8. PMID 23656433
• Fan Y, To MKT, Kuang GM, Lou N, Zhu F, Tao H, Li G, Yeung EHK, Cheung KMC, Cheung JPY. Five days of inpatient scoliosis-specific exercises improve preoperative spinal flexibility and facilitate curve correction of patients with rigid idiopathic scoliosis. Spine Deform. 2025 Jan;13(1):165-175. doi: 10.1007/s43390-024-00965-1. Epub 2024 Sep 26. PMID 39325330

Идентификаторы

NCT: NCT07516574 · Pro00150871

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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