Back to resultsAquatic Therapy in Patients With Adquired Brain Injury.
Primary Purpose
Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
aquatic therapy
Dry land therapy
Combined therapy
Sponsored by
About this trial
This is an interventional other trial for Acquired Brain Injury focused on measuring aquatic therapy; balance; acquired brain injury.
Eligibility Criteria
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
Sites / Locations
- Sagrario
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ai Chi
Arm Description
Ai Chi aquatic therapy Dry land therapy
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04168164
First Posted
November 13, 2019
Last Updated
November 15, 2019
Sponsor
Universidad de Almeria
1. Study Identification
Unique Protocol Identification Number
NCT04168164
Brief Title
Aquatic Therapy in Patients With Adquired Brain Injury.
Official Title
Aquatic Therapy in Patients With Adquired Brain Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
aquatic therapy; balance; acquired brain injury.
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
This study was a randomized, single-blinded controlled trial. The participants were recruited from three brain injury associations and those who fulfilled the inclusion criteria were randomly assigned to three treatment groups.
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ai Chi
Arm Type
Experimental
Arm Description
Ai Chi aquatic therapy Dry land therapy
Intervention Type
Other
Intervention Name(s)
aquatic therapy
Intervention Description
The exercises of Ai Chi were performed in a specific order, until completion of the total possible movements.
Intervention Type
Other
Intervention Name(s)
Dry land therapy
Intervention Description
sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs
Intervention Type
Other
Intervention Name(s)
Combined therapy
Intervention Description
alternate sessions of therapy on dry land and aquatic therapy with Ai Chi
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
6 months
Title
Five Times Sit-to-Stand test
Description
The participants were seated with their arms crossed and they were asked to stand up and sit down five times as fast as possible
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagrario Pérez- de la Cruz, Ph D
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sagrario
City
Almería
ZIP/Postal Code
04120
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Aquatic Therapy in Patients With Adquired Brain Injury.
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