Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

Not Applicable

• Conditions: Brain-injury

• Registration Number: NCT05151497
• Lead Sponsor: University of Cadiz

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-10-20
• Study First Submitted: 2021-10-23
• Study First Submitted QC: 2021-11-28
• Status Verified: 2021-12
• Study First Posted: 2021-12-09
• Last Update Submitted: 2021-12-11
• Last Update Posted: 2021-12-14
• Primary Completion: 2021-12-27
• Study Completion: 2022-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (3)

Miriam García Blanco; 🇪🇸 Cadiz, Cádiz, Spain

Asociación de Daño Cerebral de Cádiz (ADACCA); 🇪🇸 Cadiz, Cádiz, Spain

University of Cadiz; 🇪🇸 Cadiz, Spain