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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04168164
Other study ID # UAlmeria
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2018
Est. completion date September 30, 2018

Study information

Verified date November 2019
Source Universidad de Almeria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 30, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Sagrario Almería

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Berg Balance Scale 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
Primary Five Times Sit-to-Stand test 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
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