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

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

Study Overview

• Status: Completed
• Conditions: Duchenne or Becker Muscular Dystrophy
• Intervention / Treatment: Other: Aquatic Therapy Group; Other: Conventional Physical Therapy Group

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziosmanpaşa
    • Istanbul, Gaziosmanpaşa, Turkey, 34255
      • Gaziosmanpasa Research and Education Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aquatic Therapy Group; in addition to the home programme exercises, aquatic exercises will be performed with a physiotherapist	Other: Aquatic Therapy Group; 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.
Active Comparator: Conventional Physical Therapy Group; Personalized exercises in the form of a home program will be demonstrated by the physiotherapist	Other: Conventional Physical Therapy Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Performance Tests (walking 10 m, climbing 4 steps and descending 4 steps)	It will be used to evaluate the functional performance of children against time. Time to climb a 4-step staircase: They will be asked to climb a 4-step stair platform in the same way they climb in daily life Descending a 4-step ladder: They will be asked to descend a 4-step ladder platform in the same way they descend in daily life. Time to walk a distance of 10 meters: Children are asked to walk a predetermined distance of 10 meters at the same pace they walk in their daily lives.Results will be recorded.	five weeks
The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module (PedsQL-3.0	The PedsQL 3.0 Neuromuscular Module scale was prepared in child self-report and parent report formats for children aged 5-18 years.The scale consists of a total of 25 items under 3 categories: symptoms related to neuromuscular disease, communication, and family resources.Items are scored on a Likert scale from 0 (never a problem) to 4 (always a problem).Higher scores on the module indicate better health-related quality of life	five weeks

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: Ceyda Ulu, Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2023
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Muscular Dystrophy; Functional Status; Balance Control; Life Quality; Aquatic Exercise Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies; Muscular Dystrophy, Duchenne
• Other Study ID Numbers: GaziosmanpasaTREH-FTR-CU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No