Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

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.

Study Overview

• Status: Recruiting
• Conditions: Brain-injury
• Intervention / Treatment: Other: Experimental group:Halliwick + Método Watsu; Other: Control group:Halliwick

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 Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam García Blanco, Máster; Phone Number: 956019000; Email: miriamgblanco@hotmail.com

Study Locations

• Spain
  • Cadiz, Spain, 11008
    • Recruiting
    • University of Cadiz
    • Contact: Miriam García Blanco, Máster; Phone Number: 956019000; Email: miriamgblanco@hotmail.com
  • Cádiz
    • Cadiz, Cádiz, Spain, 11008
      • Recruiting
      • Miriam García Blanco
      • Contact: Miriam García Blanco, Máster; Phone Number: 956019000; Email: miriamgblanco@hotmail.com
      • Principal Investigator: Miriam García Blanco
    • Cadiz, Cádiz, Spain, 11011
      • Recruiting
      • Asociación de Daño Cerebral de Cádiz (ADACCA)
      • Contact: Miriam García Blanco, Máster; Phone Number: 956019000; Email: miriamgblanco@hotmail.com
      • Principal Investigator: Miriam García Blanco, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group: Halliwick + Método Watsu; 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.	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.
Active Comparator: Control group:Halliwick; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cadiz
• Investigators: Principal Investigator: Miriam García Blanco, Máster, University of Cadiz

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Anticipated): December 27, 2021
• Study Completion (Anticipated): January 15, 2022

Study Registration Dates

• First Submitted: October 23, 2021
• First Submitted That Met QC Criteria: November 28, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: aquatic therapy; hemiparesis; spasticity; Acquired brain damage
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Muscle Hypertonia; Brain Injuries; Muscle Spasticity
• Other Study ID Numbers: Universitiy of Cádiz

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No