Acquired Brain InjuryNCT04168164
Aquatic Therapy in Patients With Adquired Brain Injury.
A study testing aquatic therapy, Dry land therapy and Combined therapy in people with Acquired Brain Injury, run by Universidad de Almeria at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- aquatic therapy, Dry land therapy and Combined therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cardiovascular and/or respiratory problems, a previous history of neurological pathologiesand the presence of coadjuvants to the acquired brain injury
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acquired Brain Injury
- Being tested
- aquatic therapy, Dry land therapy, Combined therapy
- Keywords
- aquatic therapy; balance; acquired brain injury.
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic therapyOther
The exercises of Ai Chi were performed in a specific order, until completion of the total possible movements.
Dry land therapyOther
sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs
Combined therapyOther
alternate sessions of therapy on dry land and aquatic therapy with Ai Chi
| Study group | Role | What they receive |
|---|---|---|
| Ai Chi | Experimental | Ai Chi aquatic therapy Dry land therapy Receives: Other: aquatic therapy; Other: Dry land therapy; Other: Combined therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start7 Jan 2018
- Primary completion1 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAGRARIO PÉREZ DE LA CRUZ, Universidad de Almeria
- Investigators
- Sagrario Pérez- de la Cruz, Ph D, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168164
- Sponsor's protocol ID
- UAlmeria
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Therapy in Patients With Adquired Brain Injury.
- ClinicalTrials.gov ID
- NCT04168164
- Acronym / sponsor ID
- UAlmeria
- Conditions
- Acquired Brain Injury
- Keywords
- aquatic therapy; balance; acquired brain injury.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ai Chi | Experimental | Other: aquatic therapy, Other: Dry land therapy, Other: Combined therapyAi Chi aquatic therapy Dry land therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- cardiovascular and/or respiratory problems, a previous history of neurological pathologiesand the presence of coadjuvants to the acquired brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aquatic therapyThe exercises of Ai Chi were performed in a specific order, until completion of the total possible movements. | Other | Ai Chi |
| Dry land therapysessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs | Other | Ai Chi |
| Combined therapyalternate sessions of therapy on dry land and aquatic therapy with Ai Chi | Other | Ai Chi |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sagrario Pérez- de la Cruz, Ph D principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic therapy, Dry land therapy and Combined therapy in people with Acquired Brain Injury, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.