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临床试验/NCT04080687
NCT04080687已完成不适用

Effect of Ankle-foot Orthoses on Patients' Confidence in Balance-related Activities

University Rehabilitation Institute, Republic of Slovenia1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年2月6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
150
试验地点
1
主要终点
ABC Scale

研究概览

简要总结

The patients at our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least one year will fill in the Activities-Specific Balance Confidence Scale (ABC Scale) for wearing the orthosis and for not wearing the orthosis. They will also answer a mini survey about falls in order to determine whether they have fallen within the last 6 months.

详细描述

The effect of the orthosis will be estimated as the difference between the two ABC Scale scores. The ABC Scale score and individual items will be compared between the fallers and the non-fallers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • patients at our Prosthetics and Orthotics Outpatient Clinic having an ankle-foot orthosis for at least 1 year

排除标准

  • insufficient cognitive ability to fill in the ABC Scale

结局指标

主要结局

ABC Scale

时间窗: At day 0

Activities-Specific Balance Confidence Scale (ABC Scale) will be filled in for the confidence without the orthosis and confidence with the orthosis. The ABC Scale is a 16-item self-report measure in which patients rate their balance confidence for performing activities. Each item is rated on a scale from 0 (no confidence) to 100 (complete confidence). Overall score is the average rating across the items.

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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