Clinical trial NCT05351138: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Dysfunction
Bowel Dysfunction
Cerebral Palsy
Neurogenic Bladder
Neurogenic Bowel
Keywords: Neuromodulation therapy
Urinary incontinence
Constipation
Voiding disorder
Abdominal massage
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
Collaborators: name: Tugtepe Pediatric Urology Clinic
First posted: 2022-04-28
Enrollment: 54
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Voiding Disorders Symptom Scoring
timeFrame: Change from Baseline at 12th week
Secondary outcomes:
measure: Bladder Diary
timeFrame: Change from Baseline at 12th week
measure: Pediatric Incontinence Quality of Life Scale
timeFrame: Change from Baseline at 12th week
measure: Rome IV Criteria
timeFrame: Change from Baseline at 12th week
measure: Bristol Stool Scale
timeFrame: Change from Baseline at 12th week
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Pelin Pişirici
state: Besiktas/Istanbul
Study officials:
affiliation: Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation
name: Betül Ünal, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department
name: Pelin Pişirici, PT, PHD
role: STUDY_DIRECTOR
affiliation: Private Tuğtepe Pediatric Urology and Surgery Clinic
name: Halil Tuğtepe, MD, Prof.
role: STUDY_CHAIR
affiliation: Private Tuğtepe Pediatric Urology and Surgery Clinic
name: Aygül Köseoğlu, PT, Msc
role: STUDY_CHAIR
References: