Impact of Chronic Kidney Disease on Postural Stability in Children: A Cross-sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- limits of stability test
研究概览
简要总结
Background: Chronic kidney disease is associated with comorbid conditions that result in physical impairments.
Objectives: Investigate the impact of chronic kidney disease (CKD) on postural stability in children compared with age matched typically developing children using Human Assessment Computer (HUMAC) balance system.
Design: An observational design (cross-sectional study). Settings: The assessment procedures were conducted at the Nephrology Unit, Zagazig University Hospitals.
Participants: Seventy-five children, age ranged from 8 to 15 years represented three groups of equal numbers; control group (typically developed), non-dialysis (stage 3 and 4) and hemodialysis group.
Outcome measures: The HUMAC balance system was used to assess the limits of stability, center of pressure and sensory organization and balance.
详细描述
Methods Study design This study is an observational cross-sectional design (prospective database study).
Participants and setting Participants included children with CKD extracted from a data set of 731 individuals with CKD diagnoses, who receive regular medical follow-up/hemodialysis at Nephrology Unit, Zagazig University Hospitals. The study was conducted from January 2018 to January 2020 in accordance with the Declaration of Helsinki (Code of Ethics of the World Medical Association). The study protocol was approved by the Ethical committee of the Faculty of Physical Therapy, Cairo University, Egypt (No.P.T.REC/012/002169). Children's par-ticipation was authorized by a signed written consent form with parent's/legal guardian's acceptance for participation before starting the study procedures.
Participants Fifty eligible volunteer children with CKD were recruited from Nephrology Unit, Zagazig University Hospitals to be enrolled in this study and allocated into either hemodialysis (on hemodialysis) or non-dialysis group (children at stage 3 and 4).
Eligible criteria:
- Medically diagnosed with CKD (regardless of medical history),
- Age ranged from eight to fifteen years,
- Both genders
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically diagnosed with CKD (regardless of medical history),
- •Age ranged from eight to fifteen years,
- •Both genders
排除标准
- •Participants were excluded if they had:
- •Communication problems such as intellectual disability, autism, Down syndrome, or cerebral palsy,
- •Significant visual or hearing problems,
- •Any neurological and/or musculoskeletal disorders which influence postural stability,
- •Chronic cardiovascular or pulmonary disorders.
结局指标
主要结局
limits of stability test
时间窗: from January 2018 to January 2020
it was measured by the HUMAC. higher scores indicate good balance
center of pressure (COP) test
时间窗: from January 2018 to January 2020
It was measured by the HUMAC balance system. COP is represented by 1. path length higher scores indicate poor balance 2. stability score with higher results indicate good balance
Clinical Test of Sensory Organization and Balance
时间窗: from January 2018 to January 2020
it was measured by the HUMAc balance system to represent the ability of the child to keep balance while standing on firm and solid surfaces alternatively with eyes open and then eyes closed
次要结局
未报告次要终点
研究者
Amira Mahmoud Abd-elmonem
Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university
Cairo University