Evaluation of a Prehabilitation Program in Patients Requiring Scoliosis Surgery.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorUniversity Hospital, Grenoble
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pre-habilitation program
Other interventionPrehabilitation 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Prehabilitation program groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
One day before surgerySecondary outcomes
1
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
Total score and scores on each dimension of the scale (child self-report) (Physical Functioning ; Emotional Functioning : Social Functioning ; School Functioning)
Time frame
Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery2
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
Total score and scores on each dimension of the scale (child self-report) (Physical Functioning ; Emotional Functioning : Social Functioning ; School Functioning)
Time frame
Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery3
Impact on changes over time in the anxiety score (HAD scale) in each patient group
HAD scale is a tool used to screen for anxiety (7 questions) and depression (7 questions) with maximum score for each category = 21 (7 or less: no symptoms ; 8 to 10: possible symptoms ; 11 or more: definite symptom)
Time frame
Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery4
Impact on changes over time in the pain score (VAS) in each patient group
Pain will be assessed using Visual Analog Scale (VAS) ranging from 0 "no pain" to 10 "maximum pain"
Time frame
Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgerySponsors and contacts
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Source ClinicalTrials.gov
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