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CompletedNCT04168164Updated Nov 19, 2019

Aquatic Therapy in Patients With Adquired Brain Injury.

An interventional study of aquatic therapy and Dry land therapy in Acquired Brain Injury, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by Universidad de Almeria · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jan 2018, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acquired Brain Injury

Keywords

  • aquatic therapy; balance; acquired brain injury.
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 45 is close to the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Universidad de Almeria is the lead sponsor of 71 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Ai Chi

    Ai Chi aquatic therapy Dry land therapy

    Other: aquatic therapy · Other: Dry land therapy · Other: Combined therapy

Interventions

  • Otheraquatic therapy

    The exercises of Ai Chi were performed in a specific order, until completion of the total possible movements.

  • OtherDry land therapy

    sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs

  • OtherCombined therapy

    alternate sessions of therapy on dry land and aquatic therapy with Ai Chi

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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

    Time frame: 6 months

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Study locations

1 site
  • Sagrario
    Almería, 04120, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04168164
Lead sponsor
Universidad de Almeria
Responsible party
SAGRARIO PÉREZ DE LA CRUZ (Principal Investigator, Universidad de Almeria) — Principal investigator
First posted
Nov 19, 2019
Start date
Jan 7, 2018
Primary completion
Jun 1, 2018
Completion
Sep 30, 2018
Last update
Nov 19, 2019

Study contacts

Sagrario Pérez- de la Cruz, Ph D
principal investigator · Universidad de Almeria

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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