Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

Brain-injury Clinical Trial

Official title:

Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151497
• Other study ID #: Universitiy of Cádiz
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: December 2021
• Source: University of Cadiz
• Contact: Miriam García Blanco, Máster
• Phone: 956019000
• Email: miriamgblanco[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: January 15, 2022
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Brain Injuries
• Brain-injury
• Muscle Spasticity

Intervention

Other:
• Experimental group:Halliwick + Método Watsu
Carrying out the Ten Points Program through the Halliwick Concept, together with the Watsu Method through a series of relaxation maneuvers and mobilization of the body in float, and an immersion time of 15 minutes without doing physical activity in a pool at a temperature of 30ºC , to decrease spasticity of various muscles.
• Control group:Halliwick
Exclusive use of treatment through the Halliwick Concept Ten Point Program, along with immersion in hot water to reduce spasticity in various muscles.

Locations

Country	Name	City	State
Spain	Asociación de Daño Cerebral de Cádiz (ADACCA)	Cadiz	Cádiz
Spain	Miriam García Blanco	Cadiz	Cádiz
Spain	University of Cadiz	Cadiz

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Asworth	0 (no increase in muscle tone) to 4 (rigid part in flex-ext); 1 = Left	Change from Baseline at 8 weeks
Primary	Modified Tardieu	0 (no resistance to movement) to 4 (10 second clonus)	Change from Baseline at 8 weeks
Primary	Medical Outcome Study-Sleep Scale	Sleep rating (1 = more trouble falling asleep, a 6 = least trouble sleeping.	Change from Baseline al 8 weeks
Primary	Number of years-Age	Years	Baseline