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

NCT05351138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-01-29

No results posted yet for this study

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

Interventions

DEVICE

TENS

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.

OTHER

Massage

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.

Sponsors & Collaborators

  • Tugtepe Pediatric Urology Clinic

    collaborator OTHER
  • Bahçeşehir University

    lead OTHER

Principal Investigators

  • Betül Ünal, PT · Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation

  • Pelin Pişirici, PT, PHD · Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department

  • Halil Tuğtepe, MD, Prof. · Private Tuğtepe Pediatric Urology and Surgery Clinic

  • Aygül Köseoğlu, PT, Msc · Private Tuğtepe Pediatric Urology and Surgery Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-09-01
Completion
2023-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351138 on ClinicalTrials.gov