Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618378
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-05
Brief Title:
Effectiveness of Biofeedback Training in Children with Neurogenic Bladder and Bowel Disorder Wıth Spina Bifida
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Biofeedback Training in Children with Neurogenic Bladder and Bowel Disorder with Spina Bifida
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 breathingThe 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 hisher parents in a 48-hour period in which the child daily schedule records the amount of fluid heshe takes in and excretes the frequency of urination the frequency of urinary incontinence the activity in which the incontinence occurs the stool heshe 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 andor nighttime urinary incontinence and urination functions The 14th question is intended to evaluate the child general quality of life In the evaluation of IBSS 12 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 050 the Cronbach Alpha value for this study was determined as 0711
Superficial EMG According to the International Continence Society ICS electromyography EMG should be performed before LUTD treatment Pelvic floor and abdominal muscle activation was performed with the same device NeuroTrac myoplus 4 Verity Medical Ltd UK which can take measurements from two different channels at the same time Activation will be checked at the initial and final evaluation and before each biofeedback exercise training to determine the condition of the pelvic floor and abdominal muscles With EMG muscle strength endurance speed coordination oscillation and relaxation time data will be recorded
Quality of life measure for children PedQL The Pediatric Quality of Life Inventory Children Hospital and Health Center San Diego California is a modular instrument used to measure health-related quality of life HRQOL in children and adolescents ages 2 to 18 years PedsQL 40 Generic Core Scales are multidimensional child self-report and parent proxy report scales developed as generic core measures to be integrated with PedsQL Disease-Specific Modules The PedsQL 40 Generic Core Scales consist of 23 items valid for healthy school and community populations as well as pediatric populations with acute and chronic health conditions
Educational Programs 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
1 An important part of urotherapy is to provide parents and children with detailed explanations of etiology prevalence and pathophysiology This will reassure parents and help them understand the causes of the childampamp39s bedwetting accidents and the rationale for treatment This will increase compliance with treatment
2 Recommendations are given regarding appropriate fluid intake and regular voiding throughout the day The child is encouraged to go to the toilet seven times a day and drink seven glasses of water
3 The correct sitting position for the toilet is explained If the feet do not touch the floor easily it is recommended to use a step stool for foot support Additionally children are taught to relax their abdomen when peeing
4 In addition to monitoring and motivation a bladder diary should be kept to give the child and parents an idea about the progress of treatment compliance with treatment and continuity
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 The second channel EMG will be placed on the transversus abdominus muscle and its activation will be checked The treatment will be completed with 30-minute sessions twice a week for 12 weeks Each session will consist of 40 cycles of 10 minutes of diaphragmatic breathing exercise followed by 20 minutes of 10 seconds of contraction followed by 20 seconds of relaxation
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 hisher parents in a 48-hour period in which the child daily schedule records the amount of fluid heshe takes in and excretes the frequency of urination the frequency of urinary incontinence the activity in which the incontinence occurs the stool heshe 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 andor nighttime urinary incontinence and urination functions The 14th question is intended to evaluate the child general quality of life In the evaluation of IBSS 12 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 050 the Cronbach Alpha value for this study was determined as 0711
Superficial EMG According to the International Continence Society ICS electromyography EMG should be performed before LUTD treatment Pelvic floor and abdominal muscle activation was performed with the same device NeuroTrac myoplus 4 Verity Medical Ltd UK which can take measurements from two different channels at the same time Activation will be checked at the initial and final evaluation and before each biofeedback exercise training to determine the condition of the pelvic floor and abdominal muscles With EMG muscle strength endurance speed coordination oscillation and relaxation time data will be recorded
Quality of life measure for children PedQL The Pediatric Quality of Life Inventory Children Hospital and Health Center San Diego California is a modular instrument used to measure health-related quality of life HRQOL in children and adolescents ages 2 to 18 years PedsQL 40 Generic Core Scales are multidimensional child self-report and parent proxy report scales developed as generic core measures to be integrated with PedsQL Disease-Specific Modules The PedsQL 40 Generic Core Scales consist of 23 items valid for healthy school and community populations as well as pediatric populations with acute and chronic health conditions
Educational Programs 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
1 An important part of urotherapy is to provide parents and children with detailed explanations of etiology prevalence and pathophysiology This will reassure parents and help them understand the causes of the childampamp39s bedwetting accidents and the rationale for treatment This will increase compliance with treatment
2 Recommendations are given regarding appropriate fluid intake and regular voiding throughout the day The child is encouraged to go to the toilet seven times a day and drink seven glasses of water
3 The correct sitting position for the toilet is explained If the feet do not touch the floor easily it is recommended to use a step stool for foot support Additionally children are taught to relax their abdomen when peeing
4 In addition to monitoring and motivation a bladder diary should be kept to give the child and parents an idea about the progress of treatment compliance with treatment and continuity
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 The second channel EMG will be placed on the transversus abdominus muscle and its activation will be checked The treatment will be completed with 30-minute sessions twice a week for 12 weeks Each session will consist of 40 cycles of 10 minutes of diaphragmatic breathing exercise followed by 20 minutes of 10 seconds of contraction followed by 20 seconds of relaxation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None