Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy

NCT05351138 | Completed

• 1 other identifier: BBD-TUGTEPE-130422
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Dysfunction; Bowel Dysfunction; Cerebral Palsy; Neurogenic Bladder; Neurogenic Bowel

Keywords

Neuromodulation therapy; Urinary incontinence; Constipation; Voiding disorder; Abdominal massage

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline at 12th week

Secondary Outcomes (4)

• Bladder Diary

  Change from Baseline at 12th week

• Pediatric Incontinence Quality of Life Scale

  Change from Baseline at 12th week

• Rome IV Criteria

  Change from Baseline at 12th week

• Bristol Stool Scale

  Change from Baseline at 12th week

Study Arms (2)

TENS Group

EXPERIMENTAL

Transcutaneus electric nerve stimulation intervention will be done for a total of 12 weeks, 2 sessions of 20 minutes per week.

Device: TENS

Masaj Group

EXPERIMENTAL

Massage intervention will be done in the form of massage practise to the abdominal region, 2 sessions of 20 minutes per week.

Other: Massage

Interventions

TENS DEVICE

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.

TENS Group

Massage OTHER

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.

Masaj Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead
• Tugtepe Pediatric Urology Clinic: collaborator

Study Sites (1)

Pelin Pişirici

Istanbul, Besiktas/Istanbul, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intestinal Diseases; Cerebral Palsy; Urinary Bladder, Neurogenic; Neurogenic Bowel; Urinary Incontinence; Constipation

Interventions

Transcutaneous Electric Nerve Stimulation; Massage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies

Study Officials

• Betül Ünal, PT

  Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Pelin Pişirici, PT, PHD

  Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department

  STUDY DIRECTOR

• Halil Tuğtepe, MD, Prof.

  Private Tuğtepe Pediatric Urology and Surgery Clinic

  STUDY CHAIR

• Aygül Köseoğlu, PT, Msc

  Private Tuğtepe Pediatric Urology and Surgery Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PT

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 28, 2022
• Study Start: January 30, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

TU (1)