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临床试验/NCT04444414
NCT04444414已完成不适用

Effect of a Manual Therapy Protocol on Balance and Mood States

University of Valencia2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2020年7月1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
101
试验地点
2
主要终点
Star Excursion Balance Test (SEBT)

研究概览

简要总结

The aims of this study was to compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants. This study will consist of a randomized controlled trial. Participants will be healthy subjects divided into 2 groups, being an experimental group that will receive a manual therapy session and a control group without treatment. It will be evaluated at the start of the study, after treatment and one week later.

详细描述

Background

Evidence suggest that the application of manual therapy could be effective in multiple pathologies, but there are few studies which have investigated the effectiveness of manual therapy in to balance and mood states.

Objective To compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants.

Metods

This is a randomized controlled trial which will be carried out with young adults. The sample will be divided into 2 groups: a) experimental group that will receive a manual therapy session; b) a control group without treatment. All subjects signed the informed consent and confidentiality of the data was reserved according to the Helsinki declaration. The treatments were carried out in the laboratories of the University of Valencia and the project was approved by the institution's ethics committee.

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
Double (Participant, Outcomes Assessor)

盲法说明

The subject does not know the group that belonged The evaluator and therapist were different people

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 30 years
  • That they can take all the tests from the study evaluations.

排除标准

  • Those who are doing some balance training program.
  • Individuals who have some deterioration in balance, regardless of whether the cause is the vestibular system, the visual, proprioceptive, any surgery.
  • Participants suffering from tingling or numbness.
  • Those who have pain in the lower limbs greater than 3 on the Visual Analog Scale.
  • That the lower limbs or in the lumbosacral region have orthopedic problems or traumatic injuries, they will not be able to participate either, including as such scoliosis, ligament pathologies, osteoarthritis, prostheses.
  • Pregnancy.

结局指标

主要结局

Star Excursion Balance Test (SEBT)

时间窗: 1-week

It consists of reaching the lower limb as much as possible, in a standing position, while the other lower limb is kept on a stable support base, at a certain point. The reaches of the leg are evaluated using three determined directions, such as the anterior, the postero-medial and the postero-lateral.

次要结局

  • Unipedal Stance Test (UPST)(1-week)
  • POMS (Profile Of Mood States)(1-week)
  • Patient Global Impression of Change (PGIC)(1-week)

研究者

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

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

研究点 (2)

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