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Clinical Trials/NCT05351138
NCT05351138
Completed
Not Applicable

Comparison the Efficiency of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy With Lower Urinary System Dysfunction

Bahçeşehir University1 site in 1 country54 target enrollmentJanuary 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bladder Dysfunction
Sponsor
Bahçeşehir University
Enrollment
54
Locations
1
Primary Endpoint
Voiding Disorders Symptom Scoring
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2023
End Date
November 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bahçeşehir University
Responsible Party
Principal Investigator
Principal Investigator

Pelin Pişirici

Assistant Professor, PT

Bahçeşehir University

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

Outcomes

Primary Outcomes

Voiding Disorders Symptom Scoring

Time Frame: Change from Baseline at 12th week

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 Outcomes

  • Rome IV Criteria(Change from Baseline at 12th week)
  • Bristol Stool Scale(Change from Baseline at 12th week)
  • Bladder Diary(Change from Baseline at 12th week)
  • Pediatric Incontinence Quality of Life Scale(Change from Baseline at 12th week)

Study Sites (1)

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