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临床试验/NCT06186310
NCT06186310已完成不适用

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

Gaziosmanpasa Research and Education Hospital2 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2023年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Pediatric Berg Balance Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Aquatic Therapy Group

Active Comparator

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

干预措施: Aquatic Therapy Group (Other)

Conventional Physical Therapy Group

Active Comparator

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

干预措施: Conventional Physical Therapy Group (Other)

结局指标

主要结局

Pediatric Berg Balance Scale

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ceyda Ulu

Assistant doctor in the department of physical medicine and rehabilitation

Gaziosmanpasa Research and Education Hospital

研究点 (2)

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