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临床试验/NCT03801772
NCT03801772已完成不适用

Effects of a Metronome on Functional Outcomes in Aquatic Therapy

Aultman Health Foundation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月21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
100
试验地点
1
主要终点
Change between initial 30 second sit to stand measure and final measurement

研究概览

简要总结

The purpose of this study is to determine if the use of a pacing device, a metronome, improves functional outcome measures in aquatic therapy when compared to a control group.

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 (Outcomes Assessor)

盲法说明

Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.

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

  • •All patients over the age of 18 assigned to aquatic therapy

排除标准

  • •Women who identify themselves as pregnant on the clinics intake sheet.
  • •Anyone unable to hear the beats of the metronome.

研究组 & 干预措施

Metronome

Active Comparator

This arm will be using the metronome as a pacing device during aquatic exercises.

干预措施: Metronome (Device)

Control

No Intervention

The patients will be educated on proper performance of aquatic exercises following normal physical therapy procedures. Patients will start with 10-20 repetitions of the exercises depending on their physical ability and progressed as the patient's strength and endurance improve. Each session will last approximately 30 to 45 minutes. The BORG scale (a valid, subjective measure of perceived exertion) will be used as a monitoring device to ensure that a desired level of exercise intensity is reached. The desired level is a score between 12 and 16. The patients will be asked to rate their level of exertion at the end of each session. Intensity of the exercises will be adjusted the next session if the patient's reported level of exertion does not fall within the desired range. The pain rating and the BORG number will be recorded for both groups in the chart and flow

结局指标

主要结局

Change between initial 30 second sit to stand measure and final measurement

时间窗: Initial evaluation and up to 8 weeks

Patient stands and sits as many times as they can in 30 seconds. The number of repetitions is recorded.

次要结局

  • Change from the initial level reported on the Numerical Pain Rating Scale and the final reported level.(Initial evaluation and up to 8 weeks)
  • Global Rating of Change(Up to 8 weeks)

研究者

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

Dan Fomich

Physical Therapist Assistant

Aultman Health Foundation

研究点 (1)

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