跳至主要内容
临床试验/NCT06732713
NCT06732713招募中不适用

Effects Of Swiss Ball Versus Frenkel Exercises on Static and Dynamic Balance in Children With Down Syndrome.

Riphah International University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Pediatric Balance Scale

研究概览

简要总结

Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.

详细描述

Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.

The current study will be randomized clinical trial, data will be collected from Children Hospital and Institute of Child Health, Lahore. The study will include 32 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlanto occipital joint will be excluded. Sample will be divided into two groups.

Group A will perform Frenkel exercises and group B will perform Swiss ball exercises along routine physical therapy. Before and after intervention period, Static and dynamic balance will be assessed by Pediatric Balance Scale, Timed Up and Go test and Romberg test. Data collection will be done before and after the intervention. Data will be analyzed through SPSS version 23.00.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about treatment

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients diagnosed with Down syndrome.
  • •Age between 8 to 13 years.
  • •Patient able to understand instructions necessary for intervention.
  • •Independent standing and walking abilities.
  • •Both the genders were included

排除标准

  • •Severe mental retardation.
  • •Any heart deficit.
  • •Visual impairments.
  • •Musculoskeletal or mobility disorder.
  • •Hearing impairements.
  • •Signs of epilepsy or instability of atlanto axial joint

研究组 & 干预措施

Swiss ball group

Experimental

Swiss ball exercises will be done and intervention period will be of 8 weeks with 3 to 4 sessions per week of about 25 to 30 minutes

干预措施: Swiss Ball (Other)

Frenkel exercise group

Experimental

Frenkel exercises will be done and intervention period will be of 8 weeks with 3 to 4 sessions per week of about 25 to 30 minutes

干预措施: Frenkel exercise (Other)

结局指标

主要结局

Pediatric Balance Scale

时间窗: 8 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 that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

Timed up and Go test

时间窗: 8 weeks

The 'timed up and go' test (TUG) is a simple, quick and widely used clinical performance- based measure of lower extremity function, mobility and fall risk. 1. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. 2. On the word "Go," begin timing. 3. Stop timing after patient sits back down. 4. Record the time. The TUG has demonstrated good test-retest reliability (ICC 0.80-0.99), validity, and sensitivity to change. It has a moderate correlation with fall risk

Romberg test

时间窗: 8 weeks

Ask the subject to stand erect with feet together and eyes closed. Stand close by as a precaution in order to stop the person from falling over. Watch the movement of the body in relation to a perpendicular object behind the subject (corner of the room, door, window etc.). A positive sign is noted when a swaying, sometimes irregular swaying and even toppling over occurs. The essential feature is that the patient becomes more unsteady with eyes closed. The essential features of the test are as follows: 1. the subject stands with feet together, eyes open and hands by the sides. 2. the subject closes the eyes while the examiner observes for a full minute. Romberg's test is positive if the patient falls while the eyes are closed. Swaying is not a positive sign as it shows proprioceptive correction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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