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Clinical Trials/NCT05151497
NCT05151497UnknownNot Applicable

Effectiveness of Aquatic Theraphy in Spasticity: Watsu and Halliwick

University of Cadiz6 sites in 1 country14 target enrollmentStarted: October 20, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
14
Locations
6
Primary Endpoint
Modified Tardieu

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Outcomes

Primary Outcomes

Modified Tardieu

Time Frame: Change from Baseline at 8 weeks

0 (no resistance to movement) to 4 (10 second clonus)

Medical Outcome Study-Sleep Scale

Time Frame: Change from Baseline al 8 weeks

Sleep rating (1 = more trouble falling asleep, a 6 = least trouble sleeping.

Number of years-Age

Time Frame: Baseline

Years

Modified Asworth

Time Frame: Change from Baseline at 8 weeks

0 (no increase in muscle tone) to 4 (rigid part in flex-ext) 1 = Left

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Miriam García Blanco

Principal investigator

University of Cadiz

Study Sites (6)

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