Effectiveness of Biofeedback Training in Children with Neurogenic Bladder and Bowel Disorder with Spina Bifida
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- The effect of biofeedback training combined with breathing on bladder and bowel functions in spina bifida patients with neurogenic bladder and bowel disorders.
研究概览
简要总结
The aim of this study is to examine and compare the bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life of children diagnosed with spina bifida who did not receive any treatment due to bladder-intestinal dysfunction, received only urotherapy training and received biofeedback training combined with breathing.
The type of study is clinical trial. Question 1: Does biofeedback training combined with breathing have an effect on bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life in spina bifida patients with neurogenic bladder and bowel disorders? Question 2: Does urotherapy training have an effect on bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life in spina bifida patients with neurogenic bladder and bowel disorders? Group 1: control group Group 2: urotherapy training group Group 3: Biofeedback exercise training group combined with breathing There will be no extra treatment to group 1. Urotherapy Training: Standard urotherapy is a combined method that includes clinical assessment (recording voiding frequencies, voiding volumes and incontinence episodes in a bladder diary), voiding habit training, behavior modification instructions, lifestyle recommendations regarding fluid intake and supporting children and their parents through the process.
Exercise Training: Urotherapy training will be given at the beginning of the treatment process. Contraction and relaxation will be applied around the external sphincter in combination with diaphragmatic breathing by visual imagery with EMG biofeedback application.
Group 1, group 2 and group 3 will be compared.
详细描述
To the best of our knowledge, no study has been found in which biofeedback training combined with breathing was applied on children with neurogenic bladder. Additionally, to the best of our knowledge, no study has been found in which biofeedback exercises were applied to children with spina bifida. Therefore, in this study, researchers aim to compare the bladder functions, pelvic floor and abdominal muscle activations and quality of life of children with spina bifida who do not have access to any alternative treatment, receive only urotherapy training and biofeedback training combined with breathing.The aim of this study is to examine and compare the bladder and bowel functions, activation of pelvic floor and abdominal muscle groups, and quality of life of children diagnosed with spina bifida who did not receive any treatment due to bladder-intestinal dysfunction, received only urotherapy training, and received biofeedback training combined with breathing.
Evaluation Methods Gross Motor Function Classification System (GMFCS): The basic scale used to classify mobility is the classification called Gross Motor Function Classification System (GMFCS). According to this classification, patients are divided into 5 groups, from level 1, who can walk without any problems, to level 5, who is wheelchair-bound.
General Headings of Each Level:
Level i: walks without restriction. Level ii: walks with restrictions. Level iii: walks using hand-held mobility devices. Level iv: self-motion is limited. Can use motorized mobility device. Level v: transported in a manually propelled wheelchair. Bladder and bowel diary: It is a form recorded by the child or his/her parents in a 48-hour period, in which the child daily schedule records the amount of fluid he/she takes in and excretes, the frequency of urination, the frequency of urinary incontinence, the activity in which the incontinence occurs, the stool he/she makes throughout the day, and the quality of the stool.
Voiding Disorders Symptom Score (VBSS): Voiding Disturbances Symptom Score (VBSS), which was developed by Akbal et al. and whose validity and reliability have been proven, includes 14 questions. The first 13 questions examine the child urinary and defecation habits, daytime and/or nighttime urinary incontinence, and urination functions; The 14th question is intended to evaluate the child general quality of life. In the evaluation of IBSS 1,2 and the 3rd question will receive a minimum of 0 and a maximum of 9 points; Min 0, max 5 points from the 4th question; Min 0, max 2 points from Questions 5, 8, 9, 11, 12 and 13; A minimum of 0 and a maximum of 33 points can be obtained from the scale, with a minimum of 0 and a maximum of 3 points from the 6th Question and a minimum of 0 and a maximum of 1 from the 7th and 10th Questions. Although the Cronbach Alpha value of the scale is 0.50, the Cronbach Alpha value for this study was determined as 0.711.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with meningomyelocele type spina bifida
- •Individuals between the ages of 5-18.
排除标准
- •Presence of lower urinary tract infection
- •Presence of abdominal surgery in the last 3 months.
结局指标
主要结局
The effect of biofeedback training combined with breathing on bladder and bowel functions in spina bifida patients with neurogenic bladder and bowel disorders.
时间窗: 3 months
The primary outcome measure will be assessed by Voiding Disorders Symptom Score . The lowest score is 34, while the highest score is 170. Scale Evaluation: An increase in the total score obtained from the scale indicates an increase in the quality of life of individuals related to the disease.
The effect of biofeedback training combined with breathing on quality of life in spina bifida patients with neurogenic bladder and bowel disorders.
时间窗: 3 months
The primary outcome measure will be assessed by The Pediatric Quality of Life Inventory (PedQL). In the inventory prepared according to the five-point Likert system, 0 = Never causes a problem, 1 = Almost never causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem and 4 = Always causes a problem. A linear conversion is applied in the calculation of the total score of the scale and it turns into 0-100 points. As the score decreases, the quality of life increases.
The effect of biofeedback training combined with breathing on activation of abdominal muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.
时间窗: 3 months
The primary outcome measure will be assessed by superficial electromyography (EMG) outcomes. With the EMG device, the maximal, average and minimum contraction stimulation frequencies of the muscles and the maximal voluntary contraction percentage data will be obtained. The measurements will be taken by placing the channel around the transversus abdominus muscle (two fingers above and medial to the anterior superior iliac spine).
The effect of biofeedback training combined with breathing on activation of pelvic floor muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.
时间窗: 3 months
The primary outcome measure will be assessed by superficial electromyography (EMG) outcomes. With the EMG device, the maximal, average and minimum contraction stimulation frequencies of the muscles and the maximal voluntary contraction percentage data will be obtained. The measurements will be taken by placing the first channel around the external sphincter at 2-7 clock.
次要结局
- The effect of urotherapy training on bladder and bowel functions in spina bifida patients with neurogenic bladder and bowel disorders.(3 months)
- The effect of urotherapy training on quality of life in spina bifida patients with neurogenic bladder and bowel disorders.(3 months)
- The effect of urotherapy training combined with breathing on activation of abdominal muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.(3 months)
- The effect of urotherapy training on activation of pelvic floor muscle groups in spina bifida patients with neurogenic bladder and bowel disorders.(3 months)
研究者
Fatma Nur Erçetin
Physiotherapist
Hasan Kalyoncu University
