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临床试验/NCT02682303
NCT02682303已完成不适用

Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年3月1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
28
试验地点
1
主要终点
Balance using a computerized dynamic posturography test: the sensory organization test

研究概览

简要总结

Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on balance control in subjects with chronic ankle instability.

Material and methods: Twenty-eight individuals successfully completed the study protocol, of whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure postural sway we used computerized dynamic posturography with Sensory Organization Test and Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the composite Sensory Organization Test score, the composite Sensory Organization Test strategy and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the centre of gravity sway velocity with open eyes and close eyes during the US test.

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)

入排标准

年龄范围
18 Years 至 28 Years(Adult)
接受健康志愿者
否

入选标准

  • •Subjects with Chronic Ankle Instability

排除标准

  • •Neurologic disease Vestibular disease

研究组 & 干预措施

elastic bandage

Experimental

In this study, Idealplast C® (6cm*2.5m) was used.

干预措施: Elastic Bandage (Idealplast C®) (Device)

Non-standardized tape (NST)

Placebo Comparator

In the NST group, Pretape Cramer® (100% cotton, 1.25cm*10m) was used.

干预措施: Pretape cramer® (non standarized tape) (Device)

结局指标

主要结局

Balance using a computerized dynamic posturography test: the sensory organization test

时间窗: 7 days

The CDP device employed in this study was Smart Equitest® version 8.2 (NeuroCom International Inc., Clackamas, OR, USA). Posturography analysis was conducted using the SOT. This test assesses postural control through the use of external stimuli on the visual and proprioceptive system. Participants were instructed to stand on the force-plate facing the visual surround. A safety harness was fixed to prevent injury from falls. Their bare feet position on force-plates was adjusted according to the height of the patient, as marked on the equipment. Subjects had to maintain their COG stable in 3 consecutive series of 20s duration for each of the 6 conditions in the test.

次要结局

未报告次要终点

研究者

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

Josue Fernandez Carnero

PhD

Universidad Rey Juan Carlos

研究点 (1)

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