Evaluation of a Prehabilitation Program in Patients Requiring Scoliosis Surgery.

NCT07852286 | Not Yet Recruiting

• 2 other identifiers: 38RC23.03162025-A01259-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Minor; Scoliosis; Juvenile; Surgery; Prehabilitation; Scoliosis; Adolescence

Keywords

Prehabilitation program; Scoliosis surgery; Adapted Physical Activity; Quality of life; Anxiety; Pain; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Impact of a personalized prehabilitation program

  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.

  One day before surgery

Secondary Outcomes (16)

• Impact on changes over time in the total score and the various dimensions of the Pediatric Quality of Life Inventory (PedsQL 4.0) for children in each patient group

  Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery

• Impact on changes over time in the total score and the various dimensions of the Pediatric Quality of Life Inventory (PedsQL 4.0) for parents in each group

  Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery

• Impact on changes over time in the anxiety score (HAD scale) in each patient group

  Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery

• Impact on changes over time in the pain score (VAS) in each patient group

  Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery

• Impact of a personalized prehabilitation program on preoperative quality of life (EQ5D-Y-3L) in pediatric patients undergoing scoliosis surgery.

  One day before surgery

Study Arms (2)

Control group

NO INTERVENTION

Standard care for scoliosis surgery - Patients not participating in the prehabilitation program

Prehabilitation program group

EXPERIMENTAL

Patients participating in the 3-month prehabilitation program

Other: Pre-habilitation program

Interventions

Pre-habilitation program OTHER

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.

Prehabilitation program group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital, Grenoble

La Tronche, France

Location

MeSH Terms

Conditions

Scoliosis; Anxiety Disorders; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Aurélien COURVOISIER

CONTACT

+33 04 76 76 37 10; acourvoisier@chu-grenoble.fr

Olivier DANIEL

CONTACT

+33 04 76 76 37 10; odaniel@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: October 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): October 30, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

FR (1)