NCT06643923

Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training in Duchenne Muscular Dystrophy

Not yet recruiting NA Last updated 16 October 2024

What this trial tests

NA trial testing Exercise in Duchenne Muscular Dystrophy (DMD) in 34 participants. Not yet recruiting.

Timeline

1 December 2024

Primary endpoint
1 December 2025

1 December 2026

Quick facts

Lead sponsor	Lokman Hekim University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	1 December 2024
Primary completion	1 December 2025
Estimated completion	1 December 2026
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Exercise
• Urotherapy

Conditions studied

• Duchenne Muscular Dystrophy (DMD) — all drugs for Duchenne Muscular Dystrophy (DMD) →
• Lower Urinary Track Symptoms — all drugs for Lower Urinary Track Symptoms →

Sponsor

Lokman Hekim University

Who can join

Adults 8 to 12, male only, with Duchenne Muscular Dystrophy (DMD) or Lower Urinary Track Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lumbopelvic stabilization-based physiotherapy and rehabilitation and urotherapy for lower urinary tract dysfunction in Duchenne Muscular Dystrophy: a randomized controlled trial.
   Öztürk D, Ayşe Karaduman A, Akbayrak T. · · 2026 · PMID 41663064 · DOI 10.1016/j.jped.2026.101511