Aquatic Therapy in Patients With Adquired Brain Injury.

November 15, 2019 updated by: SAGRARIO PÉREZ DE LA CRUZ, Universidad de Almeria
The aim of this study is to compare the relative effectiveness of three different treatment groups for improvements of postural control and for improvements of balance in these patients using aquatic therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty-five patients diagnosed with acquired brain injury, with over one year's evolution and independent gait over a distance of 10 meters, with our without the use of an orthopedic aid, were selected and randomized in 3 groups. Dry land therapy group (DT group), which received sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs; Experimental group (EG group) , which received Ai Chi aquatic therapy; Combined group (DT+EG group), which received alternate sessions of therapy on dry land and aquatic therapy with Ai Chi.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Sagrario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a diagnosis of acquired brain injury traumatic or non-traumatic, with over one year's evolution
  • the ability to walk independently over a distance of more than 10 meters, with or without an orthopedic aid
  • scores on the Mini- Mental State Examination > 24

Exclusion Criteria:

  • cardiovascular and/or respiratory problems, a previous history of neurological pathologiesand the presence of coadjuvants to the acquired brain injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ai Chi
Ai Chi aquatic therapy Dry land therapy
Other: aquatic therapy
The exercises of Ai Chi were performed in a specific order, until completion of the total possible movements.
Other: Dry land therapy
sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs
Other: Combined therapy
alternate sessions of therapy on dry land and aquatic therapy with Ai Chi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 6 months
The test consists of sitting, getting up, maintaining the standing position and changing positions, with a total of 14 items. The total possible score is 56 points, The scores on the Berg balance scale were classified as follows: high risk of falls (0-20), moderate risk (21-40) and low risk (> 41) with higher scores indicating that the person has better balance.
6 months
Five Times Sit-to-Stand test
Time Frame: 6 months
The participants were seated with their arms crossed and they were asked to stand up and sit down five times as fast as possible
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Investigators

  • Principal Investigator: Sagrario Pérez- de la Cruz, Ph D, Universidad de Almeria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2018

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAlmeria

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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