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

NCT06186310 | Completed

• 1 other identifier: GaziosmanpasaTREH-FTR-CU-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne or Becker Muscular Dystrophy

Keywords

Aquatic Exercise Therapy; Muscular Dystrophy; Life Quality; Functional Status; Balance Control

Outcome Measures

Primary Outcomes (1)

• Pediatric Berg Balance Scale

  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.

  five weeks

Secondary Outcomes (2)

• 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 Arms (2)

Aquatic Therapy Group

ACTIVE COMPARATOR

in addition to the home programme exercises, aquatic exercises will be performed with a physiotherapist

Other: Aquatic Therapy Group

Conventional Physical Therapy Group

ACTIVE COMPARATOR

Personalized exercises in the form of a home program will be demonstrated by the physiotherapist

Other: Conventional Physical Therapy Group

Interventions

Aquatic Therapy Group OTHER

After the initial evaluations, patients will be given aquatic exercises including personalized strengthening, balance and breathing exercises accompanied by a physiotherapist 3 days a week for total 5 weeks. At the same time, the exercises taught as a home program will be asked to be repeated every day for 5 weeks.

Aquatic Therapy Group

Conventional Physical Therapy Group OTHER

After the initial evaluations, patients in the control group will be taught passive, active, actively assisted or resistant upper and lower extremity exercises as a home program, appropriate to each patient's functional level and muscle strength. Subjects will be asked to perform the exercises every day for 5 weeks, not exceeding an average of 45 minutes, 5 to 10 repetitions of each exercise, depending on fatigue.

Conventional Physical Therapy Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

Location

Related Publications (1)

• Yilmaz CU, Karabulut SS, Forestier FBE, Yalcinkaya EY. Effectiveness of aquatic therapy on balance and functionality in children with Duchenne and Becker muscular dystrophy : a prospective controlled pilot study. Dev Neurorehabil. 2026 Jan 31:1-8. doi: 10.1080/17518423.2026.2624412. Online ahead of print.

  PMID: 41620441 DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ceyda Ulu

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant doctor in the department of physical medicine and rehabilitation

Model Details: Two groups with a conventional physical therapy control group

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: November 5, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 29, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)