Clinical trial NCT06643923: Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training in Duchenne Muscular Dystrophy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Duchenne Muscular Dystrophy (DMD)
Lower Urinary Track Symptoms
Keywords: Duchenne muscular dystrophy
lower urinary tract symptoms
urotherapy
lumbopelvic exercise
physiotherapy
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2024-10-16
Enrollment: 34
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children and their families who have scored 8.5 or higher on the DVSS will be invited for further evaluation. Participants will be divided into two groups (Treatment and Active Control) using a 6-way block randomization method among the volunteer families.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Lower urinary tract symptoms assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: Bowel symptom assessment
timeFrame: 8 weeks
measure: Physical performance assessment
timeFrame: 8 weeks
measure: Muscle strength assessment
timeFrame: 8 weeks
measure: Lumbar lordosis angle assessment
timeFrame: 8 weeks
measure: Evaluation of participation in daily living activities
timeFrame: 8 weeks
measure: Perceived well-being assessment
timeFrame: 8 weeks
measure: Physical performance assessment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
state: Çankaya
Study officials:
References: