NCT06643923

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Lokman Hekim University · Other Government
• Sex: Male
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Duchenne Muscular Dystrophy (DMD)
• Lower Urinary Track Symptoms

Interventions

Type	Name	Description
OTHER	Exercise	F (Frequency): 3 days per week, with a total of 24 sessions. I (Intensity): Low to moderate intensity exercises with progression, ensuring no fatigue is induced. T (Time): Each session will last 30 minutes, over a total period of 8 weeks. T (Type): Warm-up exercises Core stabilization exercises: Aimed at improving core stability. Cool-down exercises E (Enjoyment): Gamified exercises, with sessions conducted to music. A (Adherence): A follow-up system will be implemented, including reminder notes and regular sending of session links to ensure compliance.
BEHAVIORAL	Urotherapy	The urotherapy education program was developed by an expert physiotherapist and was piloted with the families of children with DMD (16 parents) prior to the study. Pre-test and post-test assessments demonstrated that the knowledge level of DMD families increased after the training. Additionally, results from the satisfaction survey indicated a high level of satisfaction among the families regarding the urotherapy education (Mean satisfaction score: 33.875/35.000, Minimum=28, Maximum=35). Therefore, it was deemed appropriate to deliver the same urotherapy presentation to the DMD families within the scope of this study. The training lasts approximately 1 hour and will be delivered to families via an online method. Each family will receive the education individually, and no group sessions will be conducted.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: Turkey (Türkiye)