Clinical Trials Logo

Clinical Trial Summary

Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation. Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial [PRPT]). Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included. Three subgroups of AIS patients are distinguished, which are monitored over two years: 1. Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264) 2. Post-brace treatment group (n=122 per arm; total n=244) 3. Post-surgery group (n=152 per arm; total n=304) Intervention: The new patient-empowered FU protocol (PE-FU) is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression or postoperative complications based on these patient-based and clinical parameters to substitute the need to obtain routine x-rays. X-rays will only be taken when progression or postoperative complications are suspected in the pre- and post-intervention groups based on predefined criteria. The standard FU protocol consists of routine full-spine radiographs and routine clinical evaluations.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05379127
Study type Interventional
Source Radboud University Medical Center
Contact Miranda L van Hooff, PhD
Phone +31 24 361 3366
Email Miranda.vanHooff@radboudumc.nl
Status Recruiting
Phase N/A
Start date July 17, 2022
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03935295 - Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis Phase 4
Recruiting NCT06262269 - Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents N/A
Not yet recruiting NCT06003010 - Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients N/A
Withdrawn NCT02590380 - Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity N/A
Completed NCT02302534 - Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA) N/A
Completed NCT05669859 - Efficacy of Postoperative Telerehabilitation in Adolescent Idiopathic Scoliosis N/A
Completed NCT05242601 - Investigation of Quality of Life in Adolescent Idiopathic Scoliosis
Recruiting NCT05919459 - Effectiveness of Acceptance and Commitment Therapy Versus Active Controls in Improving Psychological Functions of Parents and Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial N/A
Recruiting NCT05969301 - Memory and Scoliosis Spinal Exercises
Enrolling by invitation NCT05790031 - Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis N/A
Active, not recruiting NCT04867148 - The Prediction and Prevention of Disease by Using Big Data in Motion Analysis N/A
Completed NCT05056363 - The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis N/A
Completed NCT00989495 - Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study N/A
Withdrawn NCT00958373 - Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis N/A
Recruiting NCT05730920 - IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction Phase 4
Recruiting NCT03292601 - Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS) N/A
Completed NCT04421157 - Exercises in Adolescent Idiopathic Scoliosis N/A
Completed NCT05127902 - Association Between Postural Balance and Muscle Activity of the Lumbar and Lower Limb Muscles in Female With or Without Adolescent Idiopathic Scoliosis (AIS) During Standing Balance Tasks With Upper Limb Movement
Completed NCT05703737 - Respiratory Function and Respiratory Muscle Strength in Adolescent Idiopathic Scoliosis
Completed NCT04092335 - Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis