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临床试验/NCT04374227
NCT04374227已完成不适用

The Effect of Osteopathic Manipulative Treatment (OMT) on Proprioception in Adults: A Pilot Study

Des Moines University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年10月16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
34
试验地点
2
主要终点
Length of pathway of center of mass

研究概览

简要总结

Participants will be recruited from the Des Moines University community and randomized into treatment and control groups. The treatment group will undergo three treatments one week apart. The control group will have an osteopathic structural exam without treatment. During the first treatment weeks both groups will undergo balance testing on a force plate pre and post intervention. Additional balance testing will take place one week after last intervention. Six variables will be compared between groups used a linear mixed model analysis.

详细描述

Participants will go through an informed consent process, fill out a screening questionnaire and will undergo neurological testing. If there are any abnormalities in their neurological testing or they meet exclusion criteria, they will not be included in the study. The neurological testing will include reflex testing, sensation testing, strength testing, and coordination and balance tests.

Participants will then be randomized into 2 groups. One control and one treatment.

Each group will have their balance measured using the portable force plate. Participants will be tested on both feet with arms crossed and eyes open for 60 seconds, and both feet with arms crossed and eyes closed for 60 seconds. Then they will be given 15 seconds to practice standing on the force plate on only their right leg with eyes open and arms crossed. The investigators will then test their balance on their right leg with arms crossed and eyes open for 30 seconds. They will be given 15 seconds to practice standing on their right leg with their arms crossed and eyes closed, and then will have their balance tested on their right leg with arms crossed and eyes closed for 30 seconds. The same sequence of events will take place for the left leg as their right leg. This sequence of measurements will take place at the beginning and end of their first treatment visit. For the standing test with eyes closed and all single leg tests someone will be standing beside the force plate with an arm and either side of the participant to prevent the participant from falling and hurting themselves.

The force plate calculates the center of mass of the participant, the area that is covered by the center of mass, the length of the path of center of mass, the velocity of its motion, and the maximum sway in the x and y planes.

During the single leg tests, the investigators will also record the time of when the participant brings the other foot down, touches the two legs together, or if the sternum becomes outside the borders of the pelvis, if they do lose their balance The test duration will be 30 seconds, as stated previously.

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

The person running the force plate and its analysis was blind to who was in the treatment group and who was not because the analysis and treatments were given in different rooms.

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

  • Participants must be 18-40 years old
  • Have the ability to give consent
  • Be able to bare weight on both feet

排除标准

  • had manipulation performed by a D.O., physical therapist, or chiropractor in the last two months,
  • had surgery in the six months
  • had broken or fractured a bone in the last six months
  • have an abnormal neurological exam
  • cerebellar dysfunction or ataxia
  • has a condition that impairs balance (including orthostatic hypertension,otoneurologic conditions, or arrhythmias)

结局指标

主要结局

Length of pathway of center of mass

时间窗: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

the center of mass of the participant is tracked on the force plate and the overall length it travels will be recorded

medial-lateral sway

时间窗: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

the center of mass of the participant is tracked on the force plate and the amount of lateral movement the point had was measured

area covered by center of mass

时间窗: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

the center of mass of the participant is tracked on the force plate and its total area covered was measured

velocity of center of mass

时间窗: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

the center of mass of the participant is tracked on the force plate and the velocity at which that point moved was measured

anterior-posterior sway

时间窗: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

the center of mass of the participant is tracked on the force plate and the amount of front-to-back movement the point had was measured

Time

时间窗: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell

we measured the amount of time participants were able to stand upright without touching the ground or having one leg touch the other in the single-leg tests

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 (2)

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