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Clinical Trials/NCT06186310
NCT06186310
Completed
Not Applicable

Effectiveness of Aquatic Therapy on Balance and Functionality in Children With Duchenne and Becker Muscular Dystrophy

Gaziosmanpasa Research and Education Hospital1 site in 1 country16 target enrollmentNovember 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Duchenne or Becker Muscular Dystrophy
Sponsor
Gaziosmanpasa Research and Education Hospital
Enrollment
16
Locations
1
Primary Endpoint
Pediatric Berg Balance Scale
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 5, 2023
End Date
February 29, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ceyda Ulu

Assistant doctor in the department of physical medicine and rehabilitation

Gaziosmanpasa Research and Education Hospital

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

Outcomes

Primary Outcomes

Pediatric Berg Balance Scale

Time Frame: five weeks

The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items: sitting to standing,standing to sitting,transfers,standing unsupported,sitting unsupported,standing with eyes closed,standing with feet together,standing with one foot in front,standing on one foot,turning 360 degrees,turning to look behind,retrieving object from floor,placing alternate foot on stool,reaching forward with outstretched arm. That are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

Secondary Outcomes

  • Timed Performance Tests (walking 10 m, climbing 4 steps and descending 4 steps)(five weeks)
  • The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module (PedsQL-3.0(five weeks)

Study Sites (1)

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