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

NCT ID: NCT06643923

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-01

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.

Conditions

Duchenne Muscular Dystrophy (DMD); Lower Urinary Track Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Urotherapy

Intervention Type: BEHAVIORAL

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.

Active Control

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.

Group Type: ACTIVE_COMPARATOR

Urotherapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lokman Hekim University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Demet Öztürk

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lokman Hekim University

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Demet Öztürk, M.Sc.

Role: CONTACT

demett.ozturkk@gmail.com

+90-5068394288

Facility Contacts

Demet Öztürk, M.Sc.

Role: primary

demet.ozturk@lokmanhekim.edu.tr

+0312 444 85 48

Other Identifiers

Lokman hekim university

Identifier Type: OTHER

Identifier Source: secondary_id

2024232

Identifier Type: -

Identifier Source: org_study_id