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临床试验/NCT07074873
NCT07074873已完成不适用

Assessment of Pelvic Floor Muscle Activation in Adolescents With Idiopathic Scoliosis

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月19日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Pelvic floor muscle activation measurement

研究概览

简要总结

Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine with a curvature of at least 10° on radiography, accompanied by rotation, seen in children aged 10-18 years, the cause of which is unknown. The pelvic floor consists of muscles and connective tissue in the shape of an equilateral triangle bounded by the symphysis pubis at the front, the sacrum at the back, and the ischial spines at the sides. The pelvic floor supports the pelvic organs, controls intra-abdominal pressure, maintains urinary and faecal control, and provides dynamic support to the body in conjunction with other core muscles. The aim of our study is to investigate pelvic floor muscle activation in adolescents with idiopathic scoliosis. Our study will include volunteers diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital who have been referred to the Spine Unit of Gaziosmanpaşa Physical Therapy Training and Research Hospital for control purposes (presence of scoliosis in the family, postural abnormalities in appearance). X-rays will be taken, and volunteers with Cobb angles below 10 degrees will be included. Taking into account a 15% loss of the calculated sample, a total of 19 patients will be included in the study. The study group will consist of individuals diagnosed with adolescent idiopathic scoliosis, and the control group will consist of healthy individuals without spinal deformities. Each individual who agrees to participate in the study will undergo evaluations. For the study group, evaluations will include Cobb angle (radiography), trunk rotation angle (forward bending test), pelvic floor muscle activation (Neurotrac Myoplus 4 Pro) for both groups, and health-related quality of life (Paediatric Quality of Life Inventory).

详细描述

Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine with a curvature of at least 10° on radiography, accompanied by rotation, seen in children aged 10-18 years, the cause of which is unknown. The pelvic floor consists of muscles and connective tissue in the shape of an equilateral triangle bounded by the symphysis pubis at the front, the sacrum at the back, and the ischial spines at the sides. The pelvic floor supports the pelvic organs, controls intra-abdominal pressure, maintains urinary and faecal control, and provides dynamic support to the body in conjunction with other core muscles. The aim of our study is to investigate pelvic floor muscle activation in adolescents with idiopathic scoliosis.

Our study will include volunteers diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital who have been referred to the Spine Unit of Gaziosmanpaşa Physical Therapy Training and Research Hospital for control purposes (presence of scoliosis in the family, postural abnormalities in appearance). X-rays will be taken, and volunteers with Cobb angles below 10 degrees will be included. Taking into account a 15% loss of the calculated sample, a total of 19 patients will be included in the study. The study group will consist of individuals diagnosed with adolescent idiopathic scoliosis, and the control group will consist of healthy individuals without spinal deformities. Each individual who agrees to participate in the study will undergo evaluations. For the study group, evaluations will include Cobb angle (radiography), trunk rotation angle (forward bending test), pelvic floor muscle activation (Neurotrac Myoplus 4 Pro) for both groups, and health-related quality of life (Paediatric Quality of Life Inventory).

Descriptive information form: The age, gender, height, weight, body mass index, age at menarche, time of initial diagnosis, how it was detected (medical history), family history (genealogy), dominant hand use, exercise habits (type of sport and duration), and corset use of individuals participating in the study will be recorded.

Health-Related Quality of Life Assessment: The Paediatric Quality of Life Inventory is a valid and reliable health-related quality of life questionnaire used for children. This inventory, which has been adapted into Turkish, consists of two forms for children and families. Both forms include sections on physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Scoring is done on a scale of 0-5 for each question (0 = Never causes a problem, 1 = Rarely causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem, and 4 = Always causes a problem). The total score of the inventory ranges from 0 to 100 points (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A high score indicates better health-related quality of life. Since our study population is aged 10-18, the inventories developed for the 8-12 and 13-18 age groups will be used.

Trunk rotation angle: The Adam's Forward Bend Test is used as the primary assessment test in the clinical examination of scoliosis patients. In our study, the scoliometer assessment will be performed on the study group while the subjects are standing with equal weight on both feet. Patients will be asked to bend forward so that their shoulder level is aligned with their hip level (body parallel to the ground), and measurements will be taken with the scoliometer, with the highest degree recorded. The Baseline Scoliometer will be used for evaluations.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis (Study Group)
  • Adolescents aged 10-18 not diagnosed with adolescent idiopathic scoliosis (Healthy partcipants) (Control Group)
  • No neurological or psychiatric disorders (Study and Control Group)
  • Parents and children must volunteer to participate in the study (Study and Control Group)

排除标准

  • For both Study and Control Group
  • Having undergone surgery on the chest, abdomen or pelvic area
  • Having undergone scoliosis surgery or being a candidate for surgery
  • Having any mental health issues
  • Having scoliosis that is not idiopathic but has arisen for other reasons (neurological, congenital, etc.)
  • Having a diagnosis of urinary incontinence
  • Being actively involved in sports

研究组 & 干预措施

Patients diagnosed with adolescent idiopathic scoliosis

Patients aged 10-18 years diagnosed with adolescent idiopathic scoliosis (Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are above 10 degrees and will be included.)

干预措施: Descriptive information form (Other)

Patients diagnosed with adolescent idiopathic scoliosis

Patients aged 10-18 years diagnosed with adolescent idiopathic scoliosis (Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are above 10 degrees and will be included.)

干预措施: Health-Related Quality of Life Assessment (Other)

Patients diagnosed with adolescent idiopathic scoliosis

Patients aged 10-18 years diagnosed with adolescent idiopathic scoliosis (Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are above 10 degrees and will be included.)

干预措施: Trunk rotation angle (Diagnostic Test)

Patients diagnosed with adolescent idiopathic scoliosis

Patients aged 10-18 years diagnosed with adolescent idiopathic scoliosis (Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are above 10 degrees and will be included.)

干预措施: Cobb angle measurement (Diagnostic Test)

Patients diagnosed with adolescent idiopathic scoliosis

Patients aged 10-18 years diagnosed with adolescent idiopathic scoliosis (Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are above 10 degrees and will be included.)

干预措施: Pelvic floor muscle activation measurement (Diagnostic Test)

Healthy participants aged 10-18 with Cobb angle of less than 10 degrees

Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are below 10 degrees will be included.

干预措施: Descriptive information form (Other)

Healthy participants aged 10-18 with Cobb angle of less than 10 degrees

Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are below 10 degrees will be included.

干预措施: Health-Related Quality of Life Assessment (Other)

Healthy participants aged 10-18 with Cobb angle of less than 10 degrees

Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are below 10 degrees will be included.

干预措施: Trunk rotation angle (Diagnostic Test)

Healthy participants aged 10-18 with Cobb angle of less than 10 degrees

Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are below 10 degrees will be included.

干预措施: Cobb angle measurement (Diagnostic Test)

Healthy participants aged 10-18 with Cobb angle of less than 10 degrees

Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are below 10 degrees will be included.

干预措施: Pelvic floor muscle activation measurement (Diagnostic Test)

结局指标

主要结局

Pelvic floor muscle activation measurement

时间窗: Within one month of receiving a diagnosis and agreeing to volunteer

Electromyographic measurement is the best-known non-invasive and practical method for measuring pelvic floor muscle activity. In our study, children's pelvic floor muscle activations will be assessed by a physiotherapist using the NeuroTrac Myoplus Pro4 device. Two surface electrodes will be placed at the 3 and 7 o'clock positions on the perineal region, and a 30×30 mm single-use electrode will be placed on the right thigh as a reference electrode. Children will be taught to contract the correct pelvic floor muscles to move in the ventral and cranial directions. The 'Work-Rest Assessment,' lasting a total of 55 seconds, will be applied to each child using the same device. First, children will be asked to relax their pelvic floor muscles. Then, 5 seconds of contraction (work) and 5 seconds of relaxation (rest) will be performed, and a total of 10 cycles of contraction and relaxation of the pelvic floor muscles will be requested. The device provides a report of the data in graphical.

次要结局

  • Health-Related Quality of Life Assessment(Within one month of receiving a diagnosis and agreeing to volunteer)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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