Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

NCT05151497 | Unknown

• 1 other identifier: Universitiy of Cádiz
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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.

Conditions

Brain-injury

Keywords

Acquired brain damage; aquatic therapy; hemiparesis; spasticity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Other: Experimental group:Halliwick + Método Watsu

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.

Other: Control group:Halliwick

Interventions

Experimental group:Halliwick + Método Watsu OTHER

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.

Experimental group: Halliwick + Método Watsu

Control group:Halliwick OTHER

Exclusive use of treatment through the Halliwick Concept Ten Point Program, along with immersion in hot water to reduce spasticity in various muscles.

Control group:Halliwick

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (3)

Miriam García Blanco

Cadiz, Cádiz, 11008, Spain

RECRUITING

Asociación de Daño Cerebral de Cádiz (ADACCA)

Cadiz, Cádiz, 11011, Spain

RECRUITING

University of Cadiz

Cadiz, 11008, Spain

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Paresis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Miriam García Blanco, Máster

  University of Cadiz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam García Blanco, Máster

CONTACT

956019000; miriamgblanco@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: December 9, 2021
• Study Start: October 20, 2021
• Primary Completion: December 27, 2021
• Study Completion: January 15, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

ES (3)