Early mobilization after scoliosis surgery in children
Early Standing in Children and Adolescent Operated on for Idiopathic Scoliosis
This study is testing if getting kids up and moving right after scoliosis surgery can help them feel better, manage pain, and be more satisfied with their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06152601 on ClinicalTrials.gov |
What this trial studies
This study aims to implement an enhanced recovery after surgery (ERAS) program for children undergoing surgery for idiopathic scoliosis. It focuses on initiating physiotherapy and mobilization as early as the immediate postoperative period in the post-anesthesia care unit (PACU) or ICU. The goal is to assess the feasibility and potential benefits of early standing and rehabilitation on patient outcomes, including pain management, anxiety reduction, and overall satisfaction. The study will monitor patients closely to ensure optimal pain relief and cooperation during early physiotherapy sessions.
Who should consider this trial
Good fit: Ideal candidates are minors scheduled for spinal surgery for idiopathic scoliosis who are eligible for an ERAS program.
Not a fit: Patients with scoliosis due to neuromuscular conditions or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and enhanced patient satisfaction for children undergoing scoliosis surgery.
How similar studies have performed: While many centers are adopting ERAS programs, this specific approach of early rehabilitation immediately post-surgery is novel and has not been widely published.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Programming of spinal surgery via the posterior approach for idiopathic scoliosis eligible for an ERAS program * Person affiliated or beneficiary of a social security scheme * Free, informed and written consent signed by the legal guardians of the minor patient * Free and informed consent of the minor patient Exclusion Criteria: * Scoliosis linked to a neuromuscular pathology * Physical status score of American Society of Anesthesiologists (ASA) \> 2 * Severe or unbalanced associated conditions (cardiac, pulmonary, coagulopathy or anticoagulant treatment with curative intent, long-term corticosteroid therapy) * Malnutrition * Major cognitive disorders * Impossibility for the parent(s) to contact the pediatrician or the hospital service if necessary (minor patients) * Pregnancy * Feeding with milk * Severe disability related to scoliosis with impossibility of ambulation * Surgical assembly planned unstable or requiring the wearing of a corset * Refusal of minor patient or of the legal guardians of the minor patient * Patient under legal protection, guardianship or curatorship
Where this trial is running
Toulouse
- CHU de TOULOUSE — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: François Dr DELORT — CHU Toulouse
- Study coordinator: François Dr DELORT
- Email: delort.f@chu-toulouse.fr
- Phone: 05 34 55 85 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.