NCT06643923Not yet recruiting
Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training in Duchenne Muscular Dystrophy
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 7 Oct 2024
- Start date
- Dec 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Lokman Hekim University
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT06643923
What you commit to
- Study type: Interventional
- Planned participants: 34
- From Dec 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having another neuromuscular disease diagnosed other than DMD and/or accompanying DMD,
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 8 years to 12 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lokman Hekim University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.