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临床试验/NCT04914364
NCT04914364已完成不适用

Describing Balance Function in Patients Post-COVID-19

Duke University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年7月23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
25
试验地点
1
主要终点
Motor Balance as Measured by Timed Up and Go (TUG)

研究概览

简要总结

The purpose of this study is to describe balance deficits in patients post COVID-19. The information the investigators learn may help influence balance training exercises for patients post-COVID-19. Participants will have a primary or secondary diagnosis of COVID-19 during hospitalization and off COVID-19 isolation and be receiving care in an acute inpatient hospital. Following consent, participants will complete balance assessments and questionnaires about balance and dizziness in a single session. Vital signs will be monitored during the session.The greatest risks of this study include shortness of breath, and a risk of falling or musculoskeletal soreness.These risks are no greater than those experienced during a usual physical therapy visit.

详细描述

Heart rate (HR), respiratory rate (RR), blood pressure (BP), and oxygen saturation (SpO2) will be measured at rest and after all outcome measures are completed. Rate of Perceived Exertion (RPE) (0-10 per modified Borg scale) will be measured after each outcome measure. In addition, HR will be measured after each outcome measure. SpO2 will be continually monitored via pulse oximetry. Fraction of inspired oxygen (FiO2) will be titrated per MD orders. If SpO2 drops below MD-specified parameters, patients will first be given a 3-minute seated rest break. If SpO2 recovers above MD-specified parameters after rest break, activity will resume. If SpO2 remains below MD-specified parameters after rest break or continues to drop with activity, FiO2 will be titrated to maintain SpO2 within MD-specified parameters.

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

  • Age > 18 years
  • Primary or secondary diagnosis of COVID- 19 during hospitalization and off COVID-19 isolation
  • Receiving care in acute inpatient
  • Ability to ambulate 20' with or without an assistive device without dropping >10% of resting oxygen saturation (determined from existing physical therapy evaluation)
  • Ability to stand with no more than contact guard assistance (determined from existing physical therapy evaluation)
  • Not requiring use of mechanical ventilation
  • Minimum resting oxygen saturation of 88% with or without supplemental oxygen
  • No neurological or orthopedic dysfunction that would affect balance
  • Cognitively intact and able to follow directions and provide consent

排除标准

  • History of 2 or more falls in the year prior to COVID-19 diagnosis or history of balance dysfunction

结局指标

主要结局

Motor Balance as Measured by Timed Up and Go (TUG)

时间窗: Baseline

The TUG measures mobility, motor balance, walking ability, and falls risk based on how long it takes the patient to stand up, walk 10 feet, turn around, walk back, and sit down. \< 10 seconds = normal, \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid, \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.

次要结局

  • Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)(Baseline)
  • Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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