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临床试验/NCT07681739
NCT07681739已完成不适用

Comparıson Of Dıfferent Exercıse Traınıng Programs In Adolescents Wıth Idıopathıc Scolıosıs Undergoıng Spınal Fusıon Surgery

NURSİMA İNCE1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Pain assessment

研究概览

简要总结

This study aimed to comparatively examine the effects of different exercise training programs on kinesiophobia, functional capacity, disability level, neck injury status, balance, body health, and quality of life in adolescent individuals diagnosed with idiopathic scoliosis (AIS) and undergoing spinal fusion planning.

A total of 42 individuals were included in the spinal fusion group and divided into three regular groups (Body Awareness Therapy + Core Stabilization: n=14, Core Stabilization: n=14, Control: n=14). Exercise programs were to be implemented twice a week for 8 weeks under the supervision of a physiotherapist. The classic exercise group received a home exercise program.

Assessments were conducted before and after the examination. The following questionnaires will be used to assess: pain (McGill Short Form Pain Questionnaire), dynamic balance (Y Balance Test), disability (Oswestry Disability Index (ODI)), body care (Body Awareness Questionnaire), functional capacity (6-animal gait test), kinesiophobia (Tampa Kinesiophobia Questionnaire), and quality of life (Scoliosis Research Association-30 (SRS-30) Questionnaire).

详细描述

Comparison of the Effects of Different Exercise Training Programs on Pain, Balance, Functional Capacity, and Quality of Life in Adolescents with Idiopathic Scoliosis and Spinal Fusion Surgery

Hasan Kalyoncu University, Graduate School, Department of Physiotherapy and Rehabilitation, PhD Thesis, Gaziantep (2025).

Body awareness refers to a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. The aim of this study is to present, based on evidence, the effects of body awareness, applied as postoperative training, on pain, quality of life, body awareness, disability, lower extremity function, functional capacity, balance, and kinesiophobia in scoliosis patients undergoing fusion surgery. Because the study focuses on body awareness, a topic that has gained importance in recent years and continues to increase in significance each year, it is anticipated to shed light on future research. Furthermore, in addition to body awareness, since studies on exercise programs for adolescent idiopathic scoliosis who have undergone surgical treatment are quite limited, this study aims to present, based on evidence, the effects of core stabilization exercises on pain, quality of life, body awareness, disability, lower extremity function, functional capacity, balance, and kinesiophobia in another group. This study is a randomized controlled trial designed to support the adaptation and healing of the fused spine in the post-discharge period after surgical treatment of adolescent idiopathic scoliosis.

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
Single (Participant)

入排标准

年龄范围
10 Months 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with adolescent idiopathic scoliosis,
  • Between the ages of 10-19,
  • Operated on with Posterior Fusion and Instrumentation technique at least 3 months and at most 4 years ago,
  • Individuals whose participation in the study was voluntary by themselves and their parents were included.

排除标准

  • Operated on with Anterior or Combined Anteroposterior Spinal Fusion and Instrumentation, Thoracoscopic Vertebral Body Stretching or Stapling techniques,
  • Previously undergone spinal surgery,
  • Having advanced neuromuscular, rheumatological, or orthopedic diseases accompanying scoliosis,
  • Presence of congenital deformity (leg shortening, limb agenesis, or hypoplasia),
  • Having a history of serious psychiatric or psychological disorders,
  • Undergoing a separate rehabilitation program with a physiotherapist,
  • In the study Those who are unable to perform the required assessment and intervention methods or who are uncooperative.

结局指标

主要结局

Pain assessment

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

Pain Assessment McGill Pain Scale Short Form: The Short-Form McGill Pain Questionnaire (SF-McGill), developed by Melzack and Torgerson in 1975, was used to assess pain levels in the individuals. The primary component of the SF-McGill consists of 15 pain-descriptive items (11 sensory and 4 affective), rated on a scale of 0 (none) to 3 (severe). The scale also includes a present pain intensity index (0 = no pain, 1 = mild, 2 = discomforting, 3 = distressing, 4 = horrible, 5 = excruciating) and a visual analog scale (VAS). Scores derived from the sensory and affective items in the first section of the scale were recorded both separately and as a total. The present pain intensity index was used to determine whether the individual was experiencing pain and, if so, to assess its severity. In the VAS section, the individual was asked to mark the severity of their pain on a 10-centimeter (cm) linear scale, which was then measured with a ruler and recorded.

Kinesiophobia assessment

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

\- Tampa Kinesiophobia Scale Kinesiophobia is a condition characterized by an individual's avoidance of physical activities due to pain-related fear; it triggers illness behavior and is associated over time with a syndrome of functional impairment and a decline in cognitive and physical performance. It is a 17-item measurement tool. The scale includes dimensions that assess fear of injury and re-injury, as well as fear-avoidance behaviors, within the context of work-related activities. Utilizing a four-point Likert-type scoring system, responses range from 1 ("Strongly disagree") to 4 ("Strongly agree"). Items 4, 8, 12, and 16 are reverse-scored, and the total score is calculated following this step. Participants can achieve a minimum score of 17 and a maximum of 68. A higher total score indicates an increased level of kinesiophobia, and the use of the total score for assessment purposes is recommended in research.

Functional capacity assessment

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

6-Minute Walk Test The Six-Minute Walk Test is a submaximal, indirect cardiovascular physical fitness test. Developed by Balke in 1963 to measure functional capacity, the test measures the distance covered in meters within 6 minutes. Because most daily living activities are performed at a submaximal level, the 6-Minute Walk Test can better reflect the level of functional exercise for everyday physical activities. Following the American Thoracic Society (ATS) guidelines, the test will be conducted for 6 minutes in a 30-meter corridor with brightly colored markers placed every 3 meters. Patients will be instructed to wear comfortable clothing and athletic shoes during the test and to avoid eating for at least two hours prior to the test.

Body Awareness Assessment

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

Body awareness involves paying attention to and focusing on internal bodily sensations. Body awareness was assessed using the Body Awareness Questionnaire (BAQ). To determine the level of sensitivity to body composition-whether normal or abnormal-the BAQ comprises four subscales (changes in bodily processes, sleep-wake cycles, prediction of illness onset, and prediction of bodily reactions) and 18 statements, such as "I notice differences in how my body reacts to various foods," "I can predict when I am coming down with the flu," and "I notice specific bodily reactions when I am extremely hungry." Individuals were asked to rate each statement on a scale from 1 (not true for me) to 7 (completely true for me). Scoring is calculated by summing the ratings given for the statements. The total score ranges from 18 to 126, with higher scores indicating greater body awareness.

Balance

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

Y Balance Test This is a valid and reliable, functional dynamic test developed from the Star Balance Test to increase measurement repeatability and standardize test performance. It is used to evaluate physical performance and dynamic balance ability in various sports. Requiring strength, flexibility, and proprioception, the aim of the Star Balance Test is to assess the ability to reach maximum distance in 8 different directions with the contralateral extremity while maintaining a balance position on one leg. Compared to expensive and non-portable computerized systems used to assess balance today, the Star Balance Test is an inexpensive, practical, and reliable test used to evaluate balance in various sports and to identify ankle instability problems in individuals

Disability Assessment

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

Oswestry Dizabilite İndeksi (ODİ) Pain intensity is assessed through 10 questions measuring the degree of pain experienced during personal care, lifting, walking, sitting, standing, sleeping, social life, and travel. Each question has 6 options. Each question is scored between 0 and 5 points. The total score ranges from 0 to 100. Higher scores increase the level of disability.

Neck Disability Level

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

The Neck Disability Index was used to assess how much neck pain affects individuals' daily lives. This questionnaire, whose Turkish validity and reliability study was conducted by Aslan and colleagues, is used to evaluate the impact of neck pain on an individual's daily living activities. Each question on the scale is scored between 0 and 5; 0 represents the best case, with no pain or functional limitations, while 5 represents the most severe pain and maximum functional limitations. This assessment tool is based on self-assessment, and participants are asked to select the option they feel best reflects their situation. All scores obtained at the end of the scale are summed to determine the individual's neck disability level.

Quality of Life Assessment

时间窗: Initial assessment: Performed between the 1st day and 2 weeks before exercise training. Second final assessment: Performed between the 1st day and 2 weeks after the completion of treatment.

The Scoliosis Research Society Questionnaire-30 (SRS-30) was used to assess the quality of life of the subjects. The scale has 5 subgroups classifying the components of quality of life: Pain: questions 1, 2, 8, 11, and 17; Function: questions 5, 9, 12, 15, and 18; Image/Appearance: questions 4, 6, 10, 14, 19, 23, 28, 29, and 30; Mental health: questions 3, 7, 13, 16, and 20; Treatment satisfaction: questions 21, 22, and 24. Each question is rated on a scale of 5 points, from 1 (worst case) to 5 (best case). The three-option questionnaire presented to patients undergoing surgical treatment is scored on a scale of 1 (bad outcome), 3 (same outcome), and 5 (good outcome), ignoring even numbers. Higher scores on the scale indicate improved quality of life.

次要结局

未报告次要终点

研究者

发起方
NURSİMA İNCE
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

NURSİMA İNCE

Physıotherapist

Hasan Kalyoncu University

研究点 (1)

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