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Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

Primary Purpose

Brain-injury

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental group:Halliwick + Método Watsu
Control group:Halliwick
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain-injury focused on measuring Acquired brain damage, aquatic therapy, hemiparesis, spasticity

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Miriam García BlancoRecruiting
  • Asociación de Daño Cerebral de Cádiz (ADACCA)Recruiting
  • University of CadizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group: Halliwick + Método Watsu

Control group:Halliwick

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 23, 2021
Last Updated
December 11, 2021
Sponsor
University of Cadiz
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1. Study Identification

Unique Protocol Identification Number
NCT05151497
Brief Title
Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick
Official Title
Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
December 27, 2021 (Anticipated)
Study Completion Date
January 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain-injury
Keywords
Acquired brain damage, aquatic therapy, hemiparesis, spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group: Halliwick + Método Watsu
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group:Halliwick
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental group:Halliwick + Método Watsu
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group:Halliwick
Intervention Description
Exclusive use of treatment through the Halliwick Concept Ten Point Program, along with immersion in hot water to reduce spasticity in various muscles.
Primary Outcome Measure Information:
Title
Modified Asworth
Description
0 (no increase in muscle tone) to 4 (rigid part in flex-ext) 1 = Left
Time Frame
Change from Baseline at 8 weeks
Title
Modified Tardieu
Description
0 (no resistance to movement) to 4 (10 second clonus)
Time Frame
Change from Baseline at 8 weeks
Title
Medical Outcome Study-Sleep Scale
Description
Sleep rating (1 = more trouble falling asleep, a 6 = least trouble sleeping.
Time Frame
Change from Baseline al 8 weeks
Title
Number of years-Age
Description
Years
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam García Blanco, Máster
Phone
956019000
Email
miriamgblanco@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam García Blanco, Máster
Organizational Affiliation
University of Cadiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miriam García Blanco
City
Cadiz
State/Province
Cádiz
ZIP/Postal Code
11008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam García Blanco, Máster
Phone
956019000
Email
miriamgblanco@hotmail.com
First Name & Middle Initial & Last Name & Degree
Miriam García Blanco
Facility Name
Asociación de Daño Cerebral de Cádiz (ADACCA)
City
Cadiz
State/Province
Cádiz
ZIP/Postal Code
11011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam García Blanco, Máster
Phone
956019000
Email
miriamgblanco@hotmail.com
First Name & Middle Initial & Last Name & Degree
Miriam García Blanco, master
Facility Name
University of Cadiz
City
Cadiz
ZIP/Postal Code
11008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam García Blanco, Máster
Phone
956019000
Email
miriamgblanco@hotmail.com

12. IPD Sharing Statement

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Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

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