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

NCT07681739 | Completed DMC

• 1 other identifier: 2025/O42
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Scoliosis Idiopathic Adolescent

Keywords

Spinal Fusion; Exercise; Body Awareness; Balance; Quality of Life.; Scoliosis

Outcome Measures

Primary Outcomes (8)

• Pain assessment

  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.

  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.

• Kinesiophobia assessment

  \- 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.

  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.

• Functional capacity assessment

  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.

  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 Assessment

  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.

  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.

• Balance

  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

  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.

• Disability Assessment

  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.

  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.

• Neck Disability Level

  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.

  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.

• Quality of Life Assessment

  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.

  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.

Study Arms (3)

Body Awareness Therapy and Core Stabilization Group

ACTIVE COMPARATOR

Participants in this group received Body Awareness Therapy in addition to core stabilization exercises. The intervention was administered twice weekly under the supervision of a physiotherapist for 8 weeks. Each session consisted of approximately 30 minutes of core stabilization exercises and an additional 30 minutes of Body Awareness Therapy. On the remaining days of the week, participants performed the prescribed exercise program independently at home. Body Awareness Therapy included a series of movements performed in different positions such as lying, sitting, standing, and walking. Considering the eight-week intervention period, the training program was structured to progress gradually on a weekly basis.

Procedure: Body Awareness Therapy; Procedure: Core Stabilization Exercises

Core Stabilization Exercise Group

ACTIVE COMPARATOR

Participants in this group received a core stabilization exercise program. Prior to implementation, all exercises were demonstrated by the physiotherapist, and during the sessions, verbal and tactile feedback were provided to ensure correct movement patterns and exercise performance. Each session began with approximately 10 minutes of warm-up exercises and ended with a 10-minute cool-down period, resulting in a total session duration of approximately 60 minutes. Progression of the exercises was individualized according to each participant's functional capacity and tolerance level. The exercise program was designed to progress gradually from 1 to 3 sets and from 7-10 repetitions to 10-15 repetitions. In addition, exercise difficulty was progressively increased through modifications in body position, the use of body weight, resistance bands, and exercise balls.

Procedure: Core Stabilization Exercises

Classic exercise group

ACTIVE COMPARATOR

In the control group undergoing classical exercise therapy, the program content consisted primarily of stretching exercises targeting the erector spinae and hamstring muscle groups, as well as strengthening exercises for the abdominal muscles, thoracic and lumbar extensors, pelvis, and shoulder girdle muscles. In addition, training to improve postural awareness and deep breathing exercises were included in the program. Following the warm-up, exercises were initially selected from lower-difficulty movements performed in a supine position, gradually progressing to more complex and challenging exercises according to the individual's tolerance. Cool-down exercises were included at the end of each program. In the first session of treatment, individuals were shown exercises to perform at home.

Procedure: Classic Exercise

Interventions

Body Awareness Therapy PROCEDURE

Body awareness refers to a holistic approach to human movement, considering the physical, physiological, psychological, and existential aspects of human existence. The educational philosophy based on this holistic perspective includes fundamental functions such as postural stability, natural breathing, and awareness. Body awareness aims to normalize muscle tension experienced and visible in posture, balance, breathing, and movement behavior. The program begins with "journey within the body" exercises in a supine position on a mat, followed by breath focus, muscle contraction and relaxation, combined breathing exercises with sound, and full-body stretching exercises. In a seated position, the program focuses on finding the correct body alignment, stimulating the core through breathing and coordination exercises, and performing trunk movements while maintaining body alignment. In a standing position, the goal is to find the correct body alignment and functional posture.

Also known as: Classic Exercise, Core Stabilization Exercises

Body Awareness Therapy and Core Stabilization Group

Core Stabilization Exercises PROCEDURE

Patients in this group will undergo a classic physiotherapy program including posture and stabilization exercises. Stabilization exercises aim to strengthen trunk muscles, increase spinal stability, support the vertebral column, and improve postural control by increasing kinesthetic awareness. The program will begin with warm-up exercises, followed by supine straight leg raises, supine hip flexion, supine shoulder flexion, supine bridge, hip abduction, cat-camel exercises, stabilization exercises with pelvic tilt while sitting on a Pilates ball, posture training in front of a mirror, upper extremity exercises while sitting on a ball, and upper extremity exercises while standing. During the exercises, movements will be made easier in conjunction with breathing. The exercises will progress from simple exercises and patterns to more complex movement patterns as control improves.

Also known as: Exercises

Body Awareness Therapy and Core Stabilization Group; Core Stabilization Exercise Group

Classic Exercise PROCEDURE

In the control group, which received classical exercise therapy, the program content consisted primarily of stretching exercises targeting the erector spinae and hamstring muscle groups, as well as strengthening exercises for the abdominal muscles, thoracic and lumbar extensors, pelvis, and shoulder girdle muscles. In addition, training to increase postural awareness and deep breathing exercises were included in the program.

Classic exercise group

Eligibility Criteria

• Age: 10 Months - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NURSİMA İNCE: lead

Study Sites (1)

Hasan Kalyoncu Üniversitesi

Gaziantep, Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Scoliosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• YAVUZ YAKUT, PROF

  HASAN KALYONCU ÜNİVERSİTESİ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physıotherapist

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: July 2, 2026
• Study Start: May 4, 2025
• Primary Completion: September 4, 2025
• Study Completion: October 4, 2025
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)