Postoperative Rehabilitation in Adolescent Idiopathic Scoliosis

NCT07791485 | Not Yet Recruiting

• 1 other identifier: karanki8
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Surgery; Rehabilitation; Scoliosis; Adolescence

Keywords

adolescent idiopathic scoliosis; postoperative rehabilitation; scoliosis surgery

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and immediately after the 8-week intervention

• 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.

  Baseline and immediately after the 8-week intervention

• 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.

  Baseline and immediately after the 8-week intervention

• 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.

  Baseline and immediately after the 8-week intervention

Secondary Outcomes (3)

• Change in Static Plantar Load Distribution

  Baseline and immediately after the 8-week intervention

• Change in Plantar Contact Area

  Baseline and immediately after the 8-week intervention

• Change in Postural Alignment

  Baseline and immediately after the 8-week intervention

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants 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.

Other: Exercise-Based Rehabilitation Program

Control Group

NO INTERVENTION

Participants 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.

Interventions

Exercise-Based Rehabilitation Program OTHER

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.

Treatment Group

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• İrem Çetinkaya, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İrem Çetinkaya, PhD

CONTACT

5548056805; iremkaranki@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-07