跳至主要内容
临床试验/NCT07791485
NCT07791485尚未招募不适用

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

Marmara University0 个研究点目标入组 42 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
Change in Center of Pressure Sway

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Double

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Exercise-Based Rehabilitation Program (Other)

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.

结局指标

主要结局

Change in Center of Pressure Sway

时间窗: Baseline and immediately after the 8-week intervention

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

时间窗: Baseline and immediately after the 8-week intervention

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

时间窗: Baseline and immediately after the 8-week intervention

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

时间窗: Baseline and immediately after the 8-week intervention

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

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