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

Lokman Hekim Üniversitesi

Status: Not yet enrolling

Conditions: Lower Urinary Track Symptoms; Duchenne Muscular Dystrophy (DMD)

Treatments: Other: Exercise; Behavioral: Urotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06643923

Lokman hekim university (Other Identifier)

2024232

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: Male

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Treatment

Experimental group

Description:

Both groups of participants will receive the same urotherapy education from the same therapist (Demet Öztürk). Following the education, both groups will be instructed to implement the lifestyle changes taught during the urotherapy education for a period of eight weeks. In addition to the education, the treatment group will receive online, supervised exercise sessions based on lumbopelvic stabilization exercises, administered by the physiotherapist. The exercise program has been designed according to the FITTEA principle, which is one of the key principles in exercise prescription.

Treatment:

Behavioral: Urotherapy

Other: Exercise

Active Control

Active Comparator group

Description:

Approximately 1.5 hours of urotherapy training will be given and the patient will be asked to apply the lifestyle changes learned in this training for 8 weeks.

Treatment:

Behavioral: Urotherapy