StrokeNCT02999971
Effects of an Aquatic Therapy Program Versus a Land Program in Patients Who Suffered a Stroke
A study testing circuit class therapy in water and circuit class therapy on land in people with Stroke and Hydrotherapy, run by Universidade da Coruña.
Trial summary
The objective of this study is to investigate the relative effectiveness of CCT on water versus on land in stroke patients. Additionally, the study will to determine if there are differences in the results obtained, between two CCT programs in the following parameters: gait, balance and dexterity Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Hydrotherapy
- What is being tested?
- circuit class therapy in water and circuit class therapy on land
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2019
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with hemiparesis secondary;
- age ≥18 to ≤ 90;
- provide a written informed consent;
- able to walk for at least 10 m without assistance
Who cannot join
- patients with uncontrolled or risky conditions (acute myocardial infarction, arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular state);
- with infectious diseases, ulcers or urinary and / or faecal incontinence;
- additional neurological and / or orthopedic deficits that alter ambulation;
- unable to follow treatment (cognitive, visual ...).
About this study
Official title: Effects of an Aquatic Circuit Class Therapy Program Versus a Land Circuit Class Therapy Program in Patients Who Suffered a Stroke
The objective of this study is to investigate the relative effectiveness of CCT on water versus on land in stroke patients. Additionally, the study will to determine if there are differences in the results obtained, between two CCT programs in the following parameters: gait, balance and dexterity
Read the detailed description
This study is a randomized controlled trial of the effectiveness of a structured CCT program in water versus a structured CCT program on land in the rehabilitation of stroke survivors.
- Conditions
- Stroke, Hydrotherapy
- Being tested
- circuit class therapy in water, circuit class therapy on land
- Keywords
- circuit class therapy, ICF model, aquatic therapy, neuro-rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circuit class therapy in waterOther
The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
circuit class therapy on landOther
The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
| Study group | Role | What they receive |
|---|---|---|
| circuit class therapy in water | Experimental | CCT on water. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions. Receives: Other: circuit class therapy in water |
| circuit class therapy on land | Experimental | CCT on land. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions. Receives: Other: circuit class therapy on land |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters walk test
Measured: 60 seconds
Secondary outcomes (8)
Test Up & Go
Measured: 5 minutes
Berg Balance Scale (BBS)
Measured: 20 minutes
Romberg Test
Measured: 1 minute
Fugl-Meyer Assessment
Measured: 15 minutes
Functional Reach Test (FRT)
Measured: 10 minutes
Box and block test
Measured: 5 minutes
Self-efficacy Scale
Measured: 5 minutes
Activities-Specific Balance Confidence Scale (ABC)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2016
- Primary completion1 Dec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRENE PEGITO PEREZ, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999971
- Sponsor's protocol ID
- UCoruna
- Status last verified
- Mar 2020
- First submitted
- 18 Dec 2016
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Aquatic Circuit Class Therapy Program Versus a Land Circuit Class Therapy Program in Patients Who Suffered a Stroke
- ClinicalTrials.gov ID
- NCT02999971
- Acronym / sponsor ID
- UCoruna
- Conditions
- Stroke, Hydrotherapy
- Keywords
- circuit class therapy, ICF model, aquatic therapy, neuro-rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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 objective of this study is to investigate the relative effectiveness of CCT on water versus on land in stroke patients. Additionally, the study will to determine if there are differences in the results obtained, between two CCT programs in the following parameters: gait, balance and dexterity
Detailed description
This study is a randomized controlled trial of the effectiveness of a structured CCT program in water versus a structured CCT program on land in the rehabilitation of stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| circuit class therapy in water | Experimental | Other: circuit class therapy in waterCCT on water. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions. |
| circuit class therapy on land | Experimental | Other: circuit class therapy on landCCT on land. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with hemiparesis secondary;
- age ≥18 to ≤ 90;
- provide a written informed consent;
- able to walk for at least 10 m without assistance
Key exclusion criteria (4 listed)
- patients with uncontrolled or risky conditions (acute myocardial infarction, arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular state);
- with infectious diseases, ulcers or urinary and / or faecal incontinence;
- additional neurological and / or orthopedic deficits that alter ambulation;
- unable to follow treatment (cognitive, visual ...).
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 |
|---|---|---|
| circuit class therapy in waterThe circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity. | Other | circuit class therapy in water |
| circuit class therapy on landThe circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity. | Other | circuit class therapy on land |
Primary outcome
10 meters walk test
Time frame: 60 seconds
8 secondary outcomes
Test Up & Go
Time frame: 5 minutes
Berg Balance Scale (BBS)
Time frame: 20 minutes
Romberg Test
Time frame: 1 minute
Fugl-Meyer Assessment
Time frame: 15 minutes
Functional Reach Test (FRT)
Time frame: 10 minutes
Box and block test
Time frame: 5 minutes
Self-efficacy Scale
Time frame: 5 minutes
Activities-Specific Balance Confidence Scale (ABC)
Time frame: 10 minutes
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 31 Mar 2020.
- Individual participant dataSharing planned: No
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing circuit class therapy in water and circuit class therapy on land in people with Stroke and Hydrotherapy, run by Universidade da Coruña.
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 4 inclusion and 4 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
10 meters walk test (time frame: 60 seconds). 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 31 Mar 2020.