NCT03625193Unknown不适用
Appropriate Methods and Psychometric Properties of Sit-to-stand Test in Ambulatory Patients With Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Ability to perform single and five times sit-to-stand test among 4 arm conditions
研究概览
简要总结
- Do different arm placements (including arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) influence outcomes of sit-to-stand test (STST) in ambulatory individuals with spinal cord injury (SCI)?
- What are the factors associated with ability to perform STST in ambulatory individuals with SCI?
- Are the single-time sit-to-stand test (STSST) and five-time sit-to-stand test (FTSST) reliable, valid and responsive to determine functional alteration in ambulatory individuals with SCI?
详细描述
- To cross-sectionally compare characteristics (duration and amount of lower limb loading) of STS movements among 4 arm placement conditions (arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) in ambulatory patients with SCI.
- To investigate reliability (inter-rater, intra-rater, and test-retest), standard error of measurement and minimal detectable changes of the STSST and FTSST in ambulatory patients with SCI.
- To investigate concurrent validity and factors associated with ability of the STSST and FTSST in ambulatory patients with SCI.
- To investigate the ability of the STSST and FTSST to predict the risk of falls over 1, 3 and 6 months in ambulatory patients with SCI.
- To investigate internal and external responsiveness of the STSST and FTSST to detect changes on walking ability over 1, 3 and 6 months in ambulatory patients with SCI.
- To estimate the minimal clinically important difference or clinical significance of the FTSST in ambulatory patients with SCI.
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
- 否
入选标准
- •Body mass index (BMI) between 18.5 - 29.9 kg/m2
- •Having an incomplete SCI from traumatic or non-traumatic causes
- •Ability of independent standing up from a chair with or without hand support
- •Ability of independent walking with or without walking device over at least 10 meters continuously.
- •Ability to follow commands used in the studies
排除标准
- •Any ambulatory individuals with incomplete SCI who present signs and symptoms that might affect ability to perform STST will be excluded from the study such as
- •Pain in the muscles or joints with an intensity of pain more than 5 out of 10 on a numeric rating scale (NRS)
- •Joint deformities that affect mobility
- •Other neurological disorders such as having brain lesions
- •Unstable medical conditions
- •Pregnancy
结局指标
主要结局
Ability to perform single and five times sit-to-stand test among 4 arm conditions
时间窗: Change over 6 months
Ability to execute a single time sit-to-stand and time used for five times sit-to-stand
次要结局
- 10-meter walk test(Change over 6 months)
- Fall events(Over 6 months)
- Global rating of change score (GRC score)(Change over 6 months)
研究者
Sugalya Amatachaya
Assoc. Prof. Dr.
Khon Kaen University
研究点 (1)
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