Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy
Primary Purpose
Bladder Dysfunction, Bowel Dysfunction, Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS
Massage
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Dysfunction focused on measuring Neuromodulation therapy, Urinary incontinence, Constipation, Voiding disorder, Abdominal massage
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 5-18
- Diagnosed with Cerebral Palsy
- Having one of the Gross Motor Function Classification System I, II, III and IV grades
- Having a complaint of urinary incontinence
Exclusion Criteria:
- Being younger than 5 years old
- Being level V according to Gross Motor Function Classification System
- Having uncontrolled epileptic seizures
- Anatomical changes in the urinary system
- Having cognitive disability
Sites / Locations
- Pelin PişiriciRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TENS Group
Masaj Group
Arm Description
Transcutaneus electric nerve stimulation intervention will be done for a total of 12 weeks, 2 sessions of 20 minutes per week.
Massage intervention will be done in the form of massage practise to the abdominal region, 2 sessions of 20 minutes per week.
Outcomes
Primary Outcome Measures
Voiding Disorders Symptom Scoring
Voiding Disorders Symptom Scoring was developed in 2005 and includes 13 questions about symptoms and 1 question about quality of life .
The scale is for parents and scoring is done according to the answers from the parents. The total score is between 0-35 points. As the score obtained from the scale increases, the severity of the patient's symptoms also increases.
Secondary Outcome Measures
Bladder Diary
The bladder diary is a simple and non-invasive method of assessing people with lower urinary tract symptoms. The International Children's Continence Society has proposed a chart to assess lower urinary tract dysfunction, showing 48-hour daytime voiding frequency, voiding volume, voiding duration, presence of urgency, type and amount of fluid intake, and degree of urinary incontinence.
Pediatric Incontinence Quality of Life Scale
Pediatric Incontinence Quality of Life Scale is the first continence quality of life scale developed in the pediatric population. It is a continence-specific quality of life scale developed for children and adolescents in 2006. The Turkish validity and reliability study was performed in 2011.
In the initial development stages of the PINQ scale, it was developed as 28 questions including 7 dimensions that evaluate children's social relations with their peers, self-esteem, family and home relations, body image, independence, mental health and treatment. In the following studies, these dimensions were grouped into two as Extrinsic (extrinsic) and Intrinsic (intrinsic), and finally the number of questions was arranged as 20. Each question is given a score of 0 (no), 1 (almost never), 2 (sometimes), 3 (often), 4 (always), and a total score (0-80) is calculated. An increase in the total score indicates that the patient's quality of life worsens .
Rome IV Criteria
Rome IV criteria allow to detect the presence of constipation in toilet trained or untrained children. Abdominal pain that recurs at least once a week in the last 3 months; If defecation is associated with at least two of the symptoms of a change in the frequency of pooping and a change in the form of poop, constipation is present according to the Rome 4 criteria.
Bristol Stool Scale
The Bristol Stool Scale (BSS) was developed by Lewis and Heaton at the University of Bristol in 1990 and classifies human faeces into 7 groups. The shape of the stool changes according to the time it stays in the colon. The BSS is a fast and reliable indicator of transit time. There are 7 different poop forms on the Bristol stool scale. Types 3 and 4 correspond to the normal poop form. Types 1 and 2 show that the person has symptoms of constipation. Tip 5,6,7 corresponds to (in order) lack of fiber, mild diarrhea and severe diarrhea.
Full Information
NCT ID
NCT05351138
First Posted
April 13, 2022
Last Updated
January 30, 2023
Sponsor
Bahçeşehir University
Collaborators
Tugtepe Pediatric Urology Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05351138
Brief Title
Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy
Official Title
Comparison the Efficiency of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy With Lower Urinary System Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University
Collaborators
Tugtepe Pediatric Urology Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There are many studies in the literature on healthy children with lower urinary tract dysfunction (LUTD), but there are limited number of studies in children with cerebral palsy (CP) with LUTD.
This study aim to contribute to the literature by examining the effectiveness of transcutaneous electrical nerve stimulation (TENS) and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.
Detailed Description
CP represents a group of chronic, non-progressive motor disorders characterized by impaired voluntary movement resulting from prenatal developmental abnormalities or perinatal or postnatal central nervous system damage.
The location and extent of neurological damage are important in determining motor and mental disabilities and the severity of the disease. Children with CP can also be affected by other medical disorders such as seizures, mental retardation, hearing, vision and communication problems. The prevalence of CP is approximately 2-3 per 1000 live births. Dysfunctional bowel and urinary dysfunction problems can often accompany CP due to motor, mental, cognitive, sensory and other neurological disorders. Severe motor disorders and/or additional cognitive deficits lead to the development of neurogenic lower urinary tract symptoms. Accoring the data obtained during the outpatient clinic visits, it was determined that most of the children with CP had LUTD complaints such as incontinence, sense of urgency, difficulty urinating, urinary retention and urinary tract infections. These urological problems affect approximately one-third of children with CP, and the prevalence of dysfunctional voiding symptoms such as pollakisuria, incontinence or urinary tract infections is estimated to be more than 30% in the population.
TENS therapy is classified as a neuromodulation therapy. In the last few years, it has been shown in the literature TENS gives positive results in the treatment of urinary symptoms.
Abdominal massage, which is one of the manual therapy techniques; the anterior abdominal wall reduces abdominal muscle tension, increases local circulation, facilitates digestion and stimulates gastric acid secretion, stimulates colonic movements by providing peristaltic stimulation. It is a classical massage method that includes clockwise manual movements over the area where the colon is located. In abdominal massage, by manually applying pressure from the anterior abdominal wall, the digestive organs are compressed between the fingers and the posterior abdominal wall and peristaltic stimulation is created. Hence, stool is pushed from the colon into the rectum. In addition, abdominal massage reduces the severity of constipation symptoms by reducing abdominal bloating and treating trigger points in the abdominal muscles.
This study aim to contribute to the literature by examining the effectiveness of TENS and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Dysfunction, Bowel Dysfunction, Cerebral Palsy, Neurogenic Bladder, Neurogenic Bowel
Keywords
Neuromodulation therapy, Urinary incontinence, Constipation, Voiding disorder, Abdominal massage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children between the ages of 5-18, diagnosed with CP with LUTD who met the inclusion criteria will be included in the study. Sample size of the study is calculated as 54. All evaluations of the participants will be done by the specialist physiotherapist who made the evaluations would not know which treatment method was applied to the participants and would be a blind evaluator.
Masking
Outcomes Assessor
Masking Description
The children to be included in the study will be randomized into two groups as the TENS group (TG) and the massage group (MG) after the first day evaluations are completed. Randomization will be done with the www.randomizer.com site. The groups of children determined according to the order of participation will be placed in opaque envelopes and the envelopes will be closed. On the second day, the physiotherapist, who will apply the treatments, will do the application according to the group that comes out of the envelope.
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TENS Group
Arm Type
Experimental
Arm Description
Transcutaneus electric nerve stimulation intervention will be done for a total of 12 weeks, 2 sessions of 20 minutes per week.
Arm Title
Masaj Group
Arm Type
Experimental
Arm Description
Massage intervention will be done in the form of massage practise to the abdominal region, 2 sessions of 20 minutes per week.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
In the study, CE certified tens device with Biolito brand, which is used specifically for incontinence treatment, will be used. The electrodes used during the intervention will be placed to the parasacral region (S2-S4). While the current is given, the power of the device will be gradually increased in 1 mA intervals. The lower value of the stimulation will be 10 mA and the upper value will be 25 mA, and the treatment will be continued with any value that the child can tolerate in this range.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
The massage will be applied to the abdominal area between the subcostal lower border and the anterior superior of the spina iliaca. Massage techniques are as follows: Abdominal patting, colon patting, colon kneading, colon patting again, abdominal patting again. It will be advanced with deep abdominal strokes, then the starting point will be returned with transverse superficial strokes for the transversus abdominis muscle and oblique superficial strokes for the rectus abdominis muscle, and these strokes will be repeated 3 times each, a total of 6 times. Afterwards, 3 times column brushing, 3 times column kneading and 3 times column plastering will be done, respectively. At the end, a total of 6 abdominal strokes will be performed for both the transversus abdominis and oblique abdominal muscles as in the beginning.
Primary Outcome Measure Information:
Title
Voiding Disorders Symptom Scoring
Description
Voiding Disorders Symptom Scoring was developed in 2005 and includes 13 questions about symptoms and 1 question about quality of life .
The scale is for parents and scoring is done according to the answers from the parents. The total score is between 0-35 points. As the score obtained from the scale increases, the severity of the patient's symptoms also increases.
Time Frame
Change from Baseline at 12th week
Secondary Outcome Measure Information:
Title
Bladder Diary
Description
The bladder diary is a simple and non-invasive method of assessing people with lower urinary tract symptoms. The International Children's Continence Society has proposed a chart to assess lower urinary tract dysfunction, showing 48-hour daytime voiding frequency, voiding volume, voiding duration, presence of urgency, type and amount of fluid intake, and degree of urinary incontinence.
Time Frame
Change from Baseline at 12th week
Title
Pediatric Incontinence Quality of Life Scale
Description
Pediatric Incontinence Quality of Life Scale is the first continence quality of life scale developed in the pediatric population. It is a continence-specific quality of life scale developed for children and adolescents in 2006. The Turkish validity and reliability study was performed in 2011.
In the initial development stages of the PINQ scale, it was developed as 28 questions including 7 dimensions that evaluate children's social relations with their peers, self-esteem, family and home relations, body image, independence, mental health and treatment. In the following studies, these dimensions were grouped into two as Extrinsic (extrinsic) and Intrinsic (intrinsic), and finally the number of questions was arranged as 20. Each question is given a score of 0 (no), 1 (almost never), 2 (sometimes), 3 (often), 4 (always), and a total score (0-80) is calculated. An increase in the total score indicates that the patient's quality of life worsens .
Time Frame
Change from Baseline at 12th week
Title
Rome IV Criteria
Description
Rome IV criteria allow to detect the presence of constipation in toilet trained or untrained children. Abdominal pain that recurs at least once a week in the last 3 months; If defecation is associated with at least two of the symptoms of a change in the frequency of pooping and a change in the form of poop, constipation is present according to the Rome 4 criteria.
Time Frame
Change from Baseline at 12th week
Title
Bristol Stool Scale
Description
The Bristol Stool Scale (BSS) was developed by Lewis and Heaton at the University of Bristol in 1990 and classifies human faeces into 7 groups. The shape of the stool changes according to the time it stays in the colon. The BSS is a fast and reliable indicator of transit time. There are 7 different poop forms on the Bristol stool scale. Types 3 and 4 correspond to the normal poop form. Types 1 and 2 show that the person has symptoms of constipation. Tip 5,6,7 corresponds to (in order) lack of fiber, mild diarrhea and severe diarrhea.
Time Frame
Change from Baseline at 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being between the ages of 5-18
Diagnosed with Cerebral Palsy
Having one of the Gross Motor Function Classification System I, II, III and IV grades
Having a complaint of urinary incontinence
Exclusion Criteria:
Being younger than 5 years old
Being level V according to Gross Motor Function Classification System
Having uncontrolled epileptic seizures
Anatomical changes in the urinary system
Having cognitive disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pelin Pişirici, PhD, PT
Phone
+902123819198
Ext
9198
Email
pelin.pisirici@hes.bau.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Halil Tuğtepe, MD, Prof.
Phone
+095335685959
Email
htugtepe@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betül Ünal, PT
Organizational Affiliation
Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pelin Pişirici, PT, PHD
Organizational Affiliation
Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Halil Tuğtepe, MD, Prof.
Organizational Affiliation
Private Tuğtepe Pediatric Urology and Surgery Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aygül Köseoğlu, PT, Msc
Organizational Affiliation
Private Tuğtepe Pediatric Urology and Surgery Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Pelin Pişirici
City
İstanbul
State/Province
Besiktas/Istanbul
ZIP/Postal Code
34353
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pelin Pişirici, PT, PhD (c)
Phone
+905055016076
Email
pelinpisirici@gmail.com
First Name & Middle Initial & Last Name & Degree
Bayram Ufuk Şakul, Prof
Phone
+905323242482
Email
usakul@medipol.edu.tr
12. IPD Sharing Statement
Learn more about this trial
Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy
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