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临床试验/NCT02705690
NCT02705690Unknown不适用

Benchmarking the iOS Balance Application Against the Berg Balance Test

Stannah Stairlifts3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
3
主要终点
Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score

研究概览

简要总结

This study aims to benchmark the performance of an iOS application against the Berg Balance Scale (BBS), which is the most commonly used assessment tool by clinicians for measuring balance across the continuum from acute care to community-based care. An iPhone will be tied around the waist of the participant and concurrent measurements will be taken for five of the fourteen stances which comprise the BBS.

详细描述

'Project Balance' aims to make balance an actionable component of an individuals health, allowing a long term intervention via a monitoring and training of balance health much before a fall happens. Towards this end, we have designed an iOS application and a belt. The phone is kept stable against the lower back of the participant using the belt. The application turns on the accelerometer in the phone to sample acceleration along x (media lateral) and z (anterior posterior) axis. These displacements from the mean are used to calculate the Root Mean Square of a person which acts a proxy score for Postural Sway. (Postural sway is defined as the phenomenon of constant displacement and correction of the position of the center of gravity within the base of support)

Studies in the past have compared the use of accelerometers to the use of the clinical measured of Timed Up (TUG) test and Berg Balance Scale (BBS) in the assessment of postural stability and indicated that there is a high correlation between BBS, TUG and Accelerometry. Accelerometry has also found to be able to distinguish between sway responses to differing balancing conditions and between fallers and non-fallers.

We aim to conduct a benchmarking study for our iOS application against the BBS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 - 69 Selected to undergo a Berg Balance Sale Impairments including : Ankle injures, Knee Replacements, Hip Replacements, Knee injuries, ligament tears etc.

排除标准

  • Subjects will be excluded from participation if they have peripheral neuropathy (clinically diagnosed or if they had symptoms of numbness/tingling in the lower extremities); pain of any level presenting simultaneously in both lower extremities; or unilateral lower extremity pain >3 on the 11 point visual analog (box) scale. Pregnant women will be excluded.

结局指标

主要结局

Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score

时间窗: Baseline

次要结局

  • Symmetry Ratio (Root Mean Square Left Leg vs Root Mean Square Right Leg) AP/ML Ratio (Ratio of the Anterior Posterior movement vs the media lateral movement)(Baseline)

研究者

发起方
Stannah Stairlifts
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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