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临床试验/NCT06502652
NCT06502652已完成不适用

Effects of Hippo Therapy Versus Balance Training on Balance and Functional Mobility in Children With Down's Syndrome

Riphah International University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
FUNCTIONAL INDEPENDENCE MEASURE

研究概览

简要总结

Down Syndrome is a genetic condition caused by having an extra copy of chromosome 21 and 47 chromosomes instead of 46. A complete or partial extra copy of chromosome 21 is responsible for the anomaly and related structural and functional abnormalities of the body systems. Depending on the degree of abnormality, Down Syndrome has different impacts on different people as a result, differences exist in personality, abilities, talents, and physical and mental development. According to this syndrome the patients shared characteristics with one another that suggested they were siblings, including a broad, flat face, a small nose, a thick tongue, narrow palpebral fissures, obliquely positioned eyes, roundish and laterally extended cheeks, a long tongue, and varying degrees of intellectual impairment.

Prior to the study, all participants will be informed of the purpose and method of conducting the research. Each of them will sign an informed consent release to participate in the project and to process personal data for scientific purposes. This study aimed to determine the effects of hippo therapy versus balance training on balance and functional mobility in children with Down's Syndrome. Randomized clinical trials will be done. The study will be conducted in special school of education, Sargodha and Najeeb ullah rehabilitation centre, Sargodha in 10 months duration after approval of synopsis. Evaluation will be done by using pediatric balance scale, times up to go test, Functional independence measure for children, Tug test for functional mobility. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation through lottery method; group A will be receiving hippo therapy and group B will be receiving balance training. Both groups will receive 8 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Data will be analyzed using SPSS-21.

详细描述

GROUP A:

Group A includes Hippo Therapy. A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally

GROUP B Group B includes balance training. The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes

研究设计

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

盲法说明

participant will get seperate treatment protocols and possible effort will be put to mask the both group about the treatment.

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age group of 6-14 years
  • Both genders

排除标准

  • Children with fixed deformity in LE
  • Child with visual and hearing problems
  • History of epilepsy

结局指标

主要结局

FUNCTIONAL INDEPENDENCE MEASURE

时间窗: 4 weeks

The maximum score on each of the 18 elements in the FIM is 7, the minimum score is 1, and the maximum possible score is 126 points. The 18 items in the FIM can be split down into two categories: five items for assessing cognitive ADL (which includes two items for communication and three items for social cognition) and thirteen items for testing motor ADL

PEDIATRIC BALANCE SCALE

时间窗: 4 weeks

It is modified berg scale the 14 items on the scale are: standing balance, sitting balance, transfers, stepping, reaching forward with outstretched arm, reaching the floor, turning, and placing foot on stool

TIMES UP TO GO TEST

时间窗: 4 weeks

The TUG was performed from a chair 40 cm high. Participants were instructed to stand and walk 3 m to a designated area at a regular pace, then turn and return to the starting position, with the time to finish being recorded. Each participant received two trials, with the best time noted.

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 (2)

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