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Starting soon Not applicable

Evaluation of a Prehabilitation Program in Patients Requiring Scoliosis Surgery.

NCT07852286 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-10-01

Condition(s) studied

MinorScoliosis; JuvenileScoliosis; AdolescenceSurgeryPrehabilitation

Investigational drug(s) / intervention(s)

Pre-habilitation program

Pre-habilitation program: Prehabilitation program in 2 steps Step 1- Physical assessment to evaluate patient's level of physical activity, motor skills, and sleep patterns: * Cardiorespiratory fitness (maximal exercise test) to measure VO2max and respiratory function. * Physical activity : Actigraphy (3 days) ; Physical Activity \[Questionnaire for Older Children (PAQ-C) or Adolescents (PAQ-A)\] * Motor skills: Flexibility ("sit and reach" test) ; Isometric strength (handgrip) ; Static balance ("Flamingo" test) ; Dynamic balance * Sleep quality: Pittsburgh Sleep Quality Index ; Actigraphy for 3 days ; Sleep diary Step 2- Personalized pre-rehabilitation program during 3 months, realized at home. Physical activity will be monitored by an adapted physical education teacher. Patient will complete a physical activity logbook during the pre-rehabilitation program, in which he will record the exercises performed and any difficulties encountered, so that subsequent sessions can be adapted accordingly.

Study summary

Scoliosis is a curvature of the spine that, in the most severe cases, may require surgical treatment. This surgery is invasive and complex, causing anxiety for children, adolescents, and their parents. In-hospital medical and surgical care is well standardized, but there are significant disparities among patients (and their families) in the psychological and physical management of this experience.

The hypothesis of the study is that a specific physical and psychological prehabilitation program (a personalized preparation known as "pre-surgical prehabilitation") could improve patient care, particularly in managing anxiety and pre- and postoperative pain throughout the care pathway.

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Patient with severe idiopathic scoliosis requiring surgery * No known associated pathology * No previous surgical treatment on the spine * Able to understand recommendations and express oneself in French * Child whose parents speak French fluently and are able to understand instructions * Parent with a myCHUGA account * Having a cellphone and an internet connection * Child whose parents are affiliated with social security or beneficiaries of such a scheme * Children who gave their consent to participate in the study * Child whose parents have signed the study consent form Exclusion Criteria: * Refusal of consent by a child of an age to give consent or by parents * Subject excluded from another study * Subject who cannot be contacted in case of an emergency * Protected persons covered by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code. * Patients whose parents are covered by Article L1121-8 of the French Public Health Code (persons subject to legal protection measures or unable to express their consent) * Personnel with a hierarchical relationship with the principal investigator

Primary outcome measure(s)

  • Impact of a personalized prehabilitation program — One day before surgery
    Hierarchical analysis of 3 subcriteria: pediatric quality of life, anxiety, and pain (difference in the total score on each scale between the two groups): * Pediatric quality of life was assessed using the PedsQL 4.0 Generic Core Scale, which consists of 23 items; the total score on this scale ranges from 0 to 100, with a higher score indicating a better quality of life. * The HAD scale is a tool used to screen for anxiety (7 questions) and depression (7 questions), with a maximum score of 21 for each category (7 or fewer: no symptoms; 8 to 10: possible symptoms; 11 or more: confirmed symptoms) * Pain will be assessed using a visual analog scale (VAS) ranging from 0 "no pain" to 10 "maximum pain." The ranking of the three subcriteria will be determined in advance by a vote of all patients (point-based voting, by majority vote). Parents will be asked to follow the same procedure (vote) to conduct a sensitivity analysis on the results obtained.

Trial sites (1)

FacilityCityRegionStatus
University Hospital, Grenoble La Tronche France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07852286 on ClinicalTrials.gov ↗ ← All trials in France