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Clinical Trials/NCT06643923
NCT06643923
Not yet recruiting
Not Applicable

Investigation of the Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training on Lower Urinary Tract Symptoms in Children With Duchenne Muscular Dystrophy and Lower Urinary Tract Dysfunction

Lokman Hekim Üniversitesi1 site in 1 country34 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Duchenne Muscular Dystrophy (DMD)
Sponsor
Lokman Hekim Üniversitesi
Enrollment
34
Locations
1
Primary Endpoint
Lower urinary tract symptoms assessment
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to examine the effectiveness of supervised lumbopelvic stabilization in relation to factors associated with lower urinary tract symptoms in children diagnosed with Duchenne Muscular Dystrophy (DMD) who have lower urinary tract dysfunction. Children aged between 8 and 12 years, at stages 1-4 according to the Vignos scale, and who have a score of 8.5 or higher on the Dysfunctional Voiding Symptom Score (DVSS), will be included in the study. Demographic information will be collected through a general assessment form, while lower urinary tract symptoms will be assessed using the DVSS, a researcher-developed evaluation form, and a three-day bladder diary. Bowel symptoms will be evaluated using the Rome IV criteria and a seven-day bowel diary. Physical performance will be assessed via the Timed Up and Go Test and Gower's Test, muscle strength using the microFET2 hand dynamometer, lumbar lordosis angle with a Bubble inclinometer, participation in daily living activities via the Barthel Index, and perceived well-being of both the child and the parent will be assessed using the Faces Rating Scale. Participants will be randomly assigned to two groups (Treatment and Active Control) using a block randomization method. In the Active Control group, children will receive only urotherapy education. In the Treatment group, children will receive supervised, online, lumbopelvic exercise-based physiotherapy and rehabilitation sessions, in addition to urotherapy, conducted by a physiotherapist. The sessions will last eight weeks, with a total of 24 sessions. At the end of the eight-week period, both groups will be re-evaluated using the same assessment methods. Intra-group and inter-group comparisons will be completed using appropriate analytical methods.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
December 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Lokman Hekim Üniversitesi
Responsible Party
Principal Investigator
Principal Investigator

Demet Öztürk

Research Assistant

Lokman Hekim Üniversitesi

Eligibility Criteria

Inclusion Criteria

  • Having been diagnosed with DMD by a specialist physician,
  • Having received a score of 8.5 or higher on the Voiding Disorders Symptom Score (VMSS),
  • Being between the ages of 8-12,
  • Continuing ambulation (Vignos Scale Stage 1-4),
  • Volunteering to participate in the study by parents and reading and signing the informed consent form.

Exclusion Criteria

  • Having another neuromuscular disease diagnosed other than DMD and/or accompanying DMD,
  • Having family and/or child having cooperation problems in completing the evaluations for any reason,
  • Lack of internet infrastructure or technical infrastructure that may cause difficulty in continuing distance education/follow-up,
  • Having difficulty in understanding and speaking the Turkish language.

Outcomes

Primary Outcomes

Lower urinary tract symptoms assessment

Time Frame: 8 weeks

Lower urinary tract symptoms will be assessed with the UIRS questionnaire. UIRS questions the frequency of lower urinary tract symptoms in the last month and measures the severity of lower urinary tract dysfunction. Akbal et al. stated that a score of 8.5 is the optimum threshold value and that this value can be used to determine whether there are functional voiding symptoms. This cut-off value will be used as the inclusion criterion in our study. In addition to the UIRS, a three-day bladder diary (voiding diary, frequency-volume chart) will be used to assess lower urinary tract symptoms. This diary allows recording bladder functions and facilitates follow-up by documenting them. In addition, it is a practical, repeatable, valid and reliable assessment method. Before the diaries are given, individuals will definitely be given training on how to fill out the diary and what to look for when filling out the diary.

Secondary Outcomes

  • Bowel symptom assessment(8 weeks)
  • Physical performance assessment(8 weeks)
  • Muscle strength assessment(8 weeks)
  • Lumbar lordosis angle assessment(8 weeks)
  • Evaluation of participation in daily living activities(8 weeks)
  • Perceived well-being assessment(8 weeks)

Study Sites (1)

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