Clinical trial NCT06186310: Effectiveness of Aquatic Therapy in Children With Duchenne and Becker Muscular Dystrophy
Official title: Effectiveness of Aquatic Therapy on Balance and Functionality in Children With Duchenne and Becker Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne or Becker Muscular Dystrophy
Keywords: Aquatic Exercise Therapy
Muscular Dystrophy
Life Quality
Functional Status
Balance Control
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-02
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a conventional physical therapy control group
Primary purpose: TREATMENT

Brief summary: The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.

Detailed description: Duchenne and Becker muscular dystrophy is the most common type of muscular dystrophy in childhood caused by a mutation of the DMD gene. Progressive muscle weakness is the main symptom, as muscle fiber degeneration is the primary pathological process.

Weakness selectively affects the proximal before the distal limb muscles and the lower before the upper limbs. The affected child therefore has difficulty running, jumping, and walking up steps.

Although there is currently no treatment method that eliminates the disease, exercise practices significantly improve the quality of life of children.

There are not enough studies in the literature evaluating whether the addition of aquatic therapy to conventional physical therapy helps to improve balance skills, functionality and quality of life in children with muscular dystrophy.

The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.

Our study will include children aged 5-18 years and complete a 10 -m walk without assistance/support who are diagnosed with Duchenne or Becker muscular dystrophy by a neurologist and followed up in the Muscular Diseases Unit of Gaziosmanpaşa Training and Research Hospital In follow-ups, patients who are planned to receive aquatic therapy will be listed according to their application dates.

In addition to the exercises home programme, patients at the top of the list will receive aquatic treatment 3 days a week for a total of 5 weeks with a physiotherapist.

Patients at the bottom of the list will form the control group and will receive home programme exercise while waiting in line for aquatic therapy After 5 weeks, the initial assessments will be repeated and recorded

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Duchenne Muscular Dystrophy or Becker Muscular Dystrophy by a neurologist
* Between the ages of 5-18, with ongoing ambulation
* Co-operating with the physiotherapist's practices

Exclusion Criteria:

* Those who will not be able to perform the evaluation parameters
* Have a serious systemic disease that may interfere with exercise
* Injury and/or surgery in the last 6 months
* Receive gene therapy
* In the presence of contraindications to aquatic therapy such as excessive fear of water, behavioral problems, shortness of breath at rest, infection, incontinence, known chlorine allergy, open wound, acute systemic disease, epilepsy, tracheotomy, permanent drain, immunodeficiency

Primary outcomes:
measure: Pediatric Berg Balance Scale
timeFrame: five weeks
Secondary outcomes:
measure: Timed Performance Tests (walking 10 m, climbing 4 steps and descending 4 steps)
timeFrame: five weeks
measure: The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module (PedsQL-3.0
timeFrame: five weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Research and Education Hospital
state: Gaziosmanpaşa
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: Ceyda Ulu
role: PRINCIPAL_INVESTIGATOR
References: