About this trial
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity occurring in growing individuals. In cases with progressive curvature, posterior spinal fusion and instrumentation (PSF) is considered the gold-standard surgical treatment for correcting the deformity and stabilizing the spine. Although surgery provides correction of the deformity, the loss of motion in the fused spinal segments may alter trunk biomechanics, potentially affecting postural control, balance mechanisms, and plantar pressure distribution.
Although several studies have investigated balance and postural control parameters in individuals with AIS, no study has been identified that objectively examines the effects of postoperative rehabilitation programs on stabilometric balance, postural control, and plantar pressure distribution following PSF surgery.
This study aims to investigate the effects of an exercise-based rehabilitation program on stabilometric balance, postural control, and plantar pressure distribution in individuals with AIS who have undergone PSF surgery. This randomized controlled trial is planned to include at least 42 individuals with AIS who have undergone PSF surgery and are being followed by the Department of Neurosurgery at Marmara University. Participants will be randomly assigned to an intervention group or a control group. The intervention group will participate in an exercise-based rehabilitation program consisting of two sessions per week for eight weeks. Consistent with routine practice, the control group will not participate in a structured rehabilitation program.
Postural control, stabilometric balance, and plantar pressure distribution will be assessed using a stabilometric and baropodometric platform system. Assessments will be conducted before and after the rehabilitation period. The findings are expected to contribute to the scientific evidence regarding postoperative rehabilitation approaches. The results may also guide clinicians in planning exercise-based rehabilitation programs following scoliosis surgery and provide patients and their families with useful information regarding the postoperative recovery process.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 10 years or older
Diagnosed with adolescent idiopathic scoliosis
Having undergone posterior spinal fusion and instrumentation between 6 months and 3 years before enrollment
Disqualifiers
Having undergone anterior spinal fusion and instrumentation, combined anteroposterior spinal fusion and instrumentation, thoracoscopic vertebral body tethering, or vertebral body stapling
A history of previous spinal surgery other than the current posterior spinal fusion procedure
The presence of a severe neuromuscular, rheumatological, or orthopedic condition accompanying scoliosis
The presence of a congenital deformity, such as leg-length discrepancy, limb agenesis, or limb hypoplasia
Trial design
Parallel
Treatments tested in this trial
Exercise-Based Rehabilitation Program
Other interventionParticipants in the experimental group will receive a supervised exercise-based rehabilitation program consisting of 16 sessions delivered twice weekly for eight weeks. Each session will last approximately 60 minutes and will be supervised by a physiotherapist. The program will focus on core muscle control, spinal mobility, and dynamic stabilization and will begin with face-to-face patient education. Exercise equipment will be provided by the researchers, and a five-minute rest period will be allowed when requested. On days without supervised sessions, participants will perform the prescribed exercises at home for approximately 20 minutes and record their adherence in an exercise diary, which will be reviewed during the supervised sessions.
Treatment groups
Trial outcomes
Primary outcomes
Change in Center of Pressure Sway
Center of pressure (CoP) sway during quiet standing will be assessed using the FreeMed® stabilometric platform and FreeStep® software. Participants will stand barefoot with their feet shoulder-width apart, arms relaxed at their sides, and eyes focused on a fixed point during a 25-second recording. Three measurements will be performed, and the mean value will be used for analysis. Lower values indicate less postural sway.
Change in Center of Pressure Sway Velocity
Center of pressure sway velocity during quiet standing will be assessed using the FreeMed® stabilometric platform and FreeStep® software during a 25-second recording. Three measurements will be performed under the same standardized conditions, and the mean value will be used for analysis. Lower values indicate slower postural sway and better postural stability.
Change in Center of Pressure Stability Ellipse Area
The stability ellipse area of the center of pressure trajectory during quiet standing will be assessed using the FreeMed® stabilometric platform and FreeStep® software during a 25-second recording. Three measurements will be performed, and the mean value will be used for analysis. A smaller ellipse area indicates less postural sway.
Change in Directional Center of Pressure Sway
Anteroposterior and mediolateral center of pressure sway during quiet standing will be assessed using the FreeMed® stabilometric platform and FreeStep® software during a 25-second recording. Anteroposterior and mediolateral sway will be recorded as separate parameters. Three measurements will be performed, and the mean values will be used for analysis. Lower values indicate less directional postural sway.
Secondary outcomes
Change in Static Plantar Load Distribution
Static plantar load distribution during quiet standing will be assessed using the FreeMed® baropodometric platform and FreeStep® software. The percentages of load distributed between the right and left feet, forefoot and rearfoot, and medial and lateral plantar regions will be recorded. Three measurements will be performed, and the mean values will be used for analysis. Values closer to an even distribution indicate greater load symmetry.
Change in Plantar Contact Area
The plantar contact area of the right and left feet during quiet standing will be assessed using the FreeMed® baropodometric platform and FreeStep® software. Contact area will be recorded separately for each foot. Three measurements will be performed, and the mean values will be used for analysis.
Change in Postural Alignment
Postural alignment will be assessed using the video analysis system integrated with the FreeMed® platform. Trunk inclination, pelvic tilt, and shoulder tilt will be recorded as separate postural alignment parameters. Three measurements will be performed using the same standardized protocol, and the mean values will be used for analysis. Values closer to neutral alignment indicate less postural asymmetry.
Locations
Sponsors and contacts
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