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临床试验/NCT05151497
NCT05151497Unknown不适用

Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

University of Cadiz3 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
14
试验地点
3
主要终点
Modified Tardieu

研究概览

简要总结

Treatment with ACD patients will be carried out through the application of aquatic therapies, being the Halliwick Concept and the Watsu Method together with a time of immersion in hot water.

详细描述

The study consists of verifying the efficacy of physiotherapeutic treatment through the use of aquatic therapies, Watsu and Halliwick in subjects who have suffered Acquired Brain Injury (ACD), and who, after that, present spasticity. For this, the users of the Brain Injury Association of Cádiz (ADACCA) are taken as references.

Brain damage is a brain injury, resulting in a series of functional and neurological alterations. The treatment of this pathology will be carried out through the application of aquatic teràpies, being the Halliwick Concept and the Watsu Method.

This study consists of a clinical trial where the experimental group will be applied the combined treatment of Halliwick and Watsu together with a time of immersion in hot water, and to the control group the treatment by Halliwick plus immersion in hot water, in order to evaluate the degree of spasticity they present at the end of the study.

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)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Belonging to the Acquired Brain Injury Association of Cádiz
  • •Presence of spasticity in the biceps brachii and soleus muscles confirmed by the modified Ashworth Scale and modified Tardieu Scale.
  • •Patients who are standing and walking at least with technical assistance and / or supervision.
  • •Patients with acquired brain damage and with spastic hemiparesis with a chronic evolution of more than 12 months.

排除标准

  • •Presence of infections.
  • •Other diagnosed diseases that prevent aquatic physiotherapy treatment, such as uncontrolled diabetes or dyspnea at rest.
  • •Have received aquatic therapy treatment in the six months prior to the study with the methods developed in the study (Halliwick or Watsu).

研究组 & 干预措施

Experimental group: Halliwick + Método Watsu

Experimental

The experimental group is made up of 7 subjects, the duration of the session being 75 minutes, divided into 45 minutes of Halliwick, 15 minutes of Watsu and finally 15 minutes of immersion in hot water. .

In the application of the Halliwick Concept, it will be carried out in a pool at a temperature of 30ºC, and through the Ten Points Program.

To carry out Watsu, the pool water must be at a temperature of 35ºC. The Watsu Basic Maneuver will be performed, consisting of a sequence of various positions where the subject must be as relaxed as possible, placed in a supine position, floating with eyes closed, and supported by the physiotherapist who is standing, with a wide base of support.

干预措施: Experimental group:Halliwick + Método Watsu (Other)

Control group:Halliwick

Active Comparator

The control group is made up of 7 subjects, the duration of the session being 75 minutes, divided into 60 minutes of Halliwick and 15 minutes of immersion in hot water. Treatment using the Halliwick Concept is carried out in a pool where the water temperature is 30ºC, following the Ten Points Program.

干预措施: Control group:Halliwick (Other)

结局指标

主要结局

Modified Tardieu

时间窗: Change from Baseline at 8 weeks

0 (no resistance to movement) to 4 (10 second clonus)

Medical Outcome Study-Sleep Scale

时间窗: Change from Baseline al 8 weeks

Sleep rating (1 = more trouble falling asleep, a 6 = least trouble sleeping.

Number of years-Age

时间窗: Baseline

Years

Modified Asworth

时间窗: Change from Baseline at 8 weeks

0 (no increase in muscle tone) to 4 (rigid part in flex-ext) 1 = Left

次要结局

未报告次要终点

研究者

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

Miriam García Blanco

Principal investigator

University of Cadiz

研究点 (3)

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