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

NCT ID: NCT06186310

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2024-02-29

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

Conditions

Duchenne or Becker Muscular Dystrophy

Study Design

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

Study Groups

Aquatic Therapy Group

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

Group Type: ACTIVE_COMPARATOR

Aquatic Therapy Group

Intervention Type: 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.

Conventional Physical Therapy Group

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

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy Group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ceyda Ulu

Assistant doctor in the department of physical medicine and rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ceyda Ulu

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Research and Education Hospital

Locations

Gaziosmanpasa Research and Education Hospital

Istanbul, Gaziosmanpaşa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziosmanpasaTREH-FTR-CU-01

Identifier Type: -

Identifier Source: org_study_id