AzTrials
AzTrials

SurgeryNCT07791485

Postoperative Rehabilitation in Adolescent Idiopathic Scoliosis

A study testing Exercise-Based Rehabilitation Program in people with Surgery and Rehabilitation, run by Marmara University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 20 years
Conditions the study is for
Surgery, Rehabilitation, Scoliosis; Adolescence
What is being tested?
Exercise-Based Rehabilitation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 1 Jun 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Current participation in another physiotherapist-supervised rehabilitation program
  • Inadequate biological healing based on radiographic assessment or being considered unsuitable for participation by the treating physician
  • Inability to perform the assessments or interventions required by the study or inability to cooperate with study procedures

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

İrem Çetinkaya, PhD contact

5548056805

iremkaranki@gmail.com

About this study

Official title: The Effect of Postoperative Rehabilitation on Stabilometric Balance, Postural Control, and Plantar Pressure Distribution in Adolescent Idiopathic Scoliosis: A Randomized Controlled 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.

Read more

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.

Read the detailed description

Scoliosis is a complex three-dimensional deformity characterized by a lateral deviation of the spine of at least 10 degrees in the coronal plane (Choudhry et al., 2016). Idiopathic scoliosis is a structural form of scoliosis for which no specific etiology has been identified. When it develops between the onset of puberty and the closure of the growth plates, it is classified as adolescent idiopathic scoliosis (AIS) (Winter, 1994; Weinstein et al., 2008).

Current treatment options for scoliosis include observation, bracing, and surgical intervention. Selection of the most appropriate treatment approach depends on factors such as the patient's age, menarcheal status, curve location and magnitude, and risk of progression (Zhang et al., 2020). Although skeletally immature children with curves reaching 40-50 degrees are generally considered candidates for surgical treatment, other factors-including curve pattern, rate of progression, the presence of additional deformities, and failure to respond to conservative treatment-may also influence the decision to perform surgery (Bridwell, 1999; Kim et al., 2009; Pourfeizi et al., 2014). Among the various surgical procedures used to treat scoliosis, posterior spinal fusion and instrumentation (PSF) is the most commonly used approach and is regarded as the gold-standard surgical technique in the literature (Lonner et al., 2007). This technique eliminates motion in the involved spinal segments by creating a fusion to correct the deformity, achieve a balanced spine, and prevent further curve progression (Upasani et al., 2015).

Alterations in balance control, postural stability, and postural sway parameters have been reported in individuals with AIS due to the three-dimensional spinal deformity. Impairments in sensorimotor integration mechanisms involving the trunk and changes in plantar pressure distribution have also been reported (Beaulieu et al., 2009; Sahli et al., 2013; Karimi et al., 2016; Dufvenberg et al., 2018). Following surgical correction, the elimination of motion in certain spinal segments may increase loading on the remaining mobile segments, leading to changes in trunk biomechanics and new adaptations in postural control mechanisms. However, the limited evidence regarding the effects of these changes and adaptations in individuals with scoliosis remains inconsistent. Previous studies have reported postoperative reductions in spinal flexibility and mobility, as well as chronic pain (Danielsson et al., 2001; Engsberg et al., 2003; Maruyama et al., 2008), decreased trunk muscle endurance (Danielsson et al., 2006), adverse effects on balance- and postural control-related parameters, or a lack of improvement in these parameters following surgery (McCance et al., 1998; de Santiago et al., 2013; Osuka et al., 2023).

Studies addressing the postoperative period have suggested that physiotherapist-supervised rehabilitation programs may be important for preventing secondary spinal problems and supporting postoperative recovery (Weiss, 2002; Laurentowska et al., 2009; Bazancir et al., 2023; Çetinkaya et al., 2025). Nevertheless, only a limited number of studies have investigated postoperative rehabilitation in individuals with AIS. Laurentowska et al. reported that a four-week endurance-based rehabilitation program initiated one to three years after surgery significantly improved exercise capacity and emphasized that rehabilitation should continue after spinal fusion in individuals with scoliosis (Laurentowska et al., 2009). Weiss demonstrated that a pain-management-based inpatient rehabilitation program could reduce chronic pain in patients who had undergone surgery at least 10 years earlier (Weiss, 2002). Short-term inpatient rehabilitation programs implemented after scoliosis surgery have also been reported to support postoperative recovery and improve quality of life (Bazancir et al., 2023). In addition, a physiotherapist-supervised telerehabilitation program initiated from the sixth postoperative month was reported to improve trunk endurance and flexibility and positively affect quality of life (Çetinkaya et al., 2025). Although these studies have addressed postoperative rehabilitation approaches, there remains a notable lack of research examining the effects of rehabilitation on biomechanical variables such as postural control mechanisms, stabilometric balance parameters, and plantar pressure distribution following surgery.

Changes in postural control and balance mechanisms may affect individuals' activities of daily living and their participation in social and physical activities. Participation in physical activity and social life is particularly important during adolescence because of its contribution to overall health and quality of life. Therefore, it is important to investigate postoperative rehabilitation approaches aimed at supporting functional capacity and facilitating the reorganization of postural control mechanisms. Further research is also needed to establish evidence-based rehabilitation programs that support the biomechanical adaptation of the fused spine and the postoperative recovery process.

Accordingly, this study aims to investigate the effects of an exercise-based postoperative rehabilitation program on stabilometric balance, postural control, and static plantar pressure distribution in individuals who have undergone PSF surgery for AIS, using objective biomechanical assessment methods. The findings are expected to contribute to the development of postoperative rehabilitation approaches and to support individuals' functional independence and quality of life. The results are also expected to provide evidence regarding the effectiveness of the exercise program and to offer guidance for clinicians working in this field, as well as for patients and their families.

Being tested
Exercise-Based Rehabilitation Program
Keywords
adolescent idiopathic scoliosis, postoperative rehabilitation, scoliosis surgery
Medical subject headings
Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise-Based Rehabilitation ProgramOther

    Participants 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.

Study groups in NCT07791485
Study groupRoleWhat they receive
Treatment GroupExperimentalParticipants who are at least six months post-surgery and are periodically invited by their physician for routine postoperative follow-up examinations, including radiological assessment and physical examination, will participate in an exercise-based rehabilitation program. The program will consist of 16 sessions delivered twice weekly for eight weeks, with each session lasting approximately 60 minutes.
Receives: Other: Exercise-Based Rehabilitation Program
Control GroupNo interventionParticipants who are at least six months post-surgery and are routinely invited by their physician for radiological assessment and physical examination at six-month intervals will not participate in any structured rehabilitation program beyond the periodic follow-up and recommendations provided as part of routine postoperative care. Participants assigned to this group will be offered the opportunity to participate in the exercise-based rehabilitation program after completing the study if they wish.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and immediately after the 8-week intervention

  2. 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.

    Measured: Baseline and immediately after the 8-week intervention

  3. 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.

    Measured: Baseline and immediately after the 8-week intervention

  4. 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.

    Measured: Baseline and immediately after the 8-week intervention

Secondary outcomes (3)
  1. 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.

    Measured: Baseline and immediately after the 8-week intervention

  2. 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.

    Measured: Baseline and immediately after the 8-week intervention

  3. 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.

    Measured: Baseline and immediately after the 8-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791485
Sponsor's protocol ID
karanki8
Status last verified
Jul 2026
First submitted
22 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in