StrokeNCT04362202
A Water-based Sequential Preparatory Approach and Stroke
A study testing Water-based Sequential Preparatory Approach in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
Many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Water-based Sequential Preparatory Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 30 Nov 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke with unilateral hemiplegia within the previous six months;
- Ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance (Functional Ambulation Classification ≥ 3);
- Acclimatization to water.
Who cannot join
- Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination > 24);
- Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
- Severe aphasia (diagnosed by means of neuropsychological assessment);
- Presence of other neurological diseases;
- Presence of cutaneous and mycosis infections;
- Presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns;
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- Presence of PEG (Percutaneous endoscopic gastrostomy);
- Presence of tracheostomy;
- Urinary incontinence;
- Presence of otitis
- Presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Water-based Sequential Preparatory Approach Versus Conventional Aquatic Training in Stroke Patients: a Randomized Controlled Trial With a One-month Follow-up
Many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living.
A Cochrane Review systematically synthesized and compared the effects of aquatic and land-based therapies on the activities of daily living (ADL) of patients following stroke and found that water-based exercises improved strength and ADL. A recent review indicates that RCTs comparing aquatic methods in both environments are lacking. The same movements in water and on dry land that target postural stability and gait require different competences. For example, the postural instability that occurs while squatting in water was enacted on land by sitting on a therapy ball. Furthermore, land-based conventional rehabilitation is generally task oriented, customized and challenging and follows a specific preparatory sequence of exercises according to patients' disabilities. Therefore, the investigators believe that a sequential preparatory approach (SPA), based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex), should also be used in an aquatic environment.
- Conditions
- Stroke
- Being tested
- Water-based Sequential Preparatory Approach
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based Sequential Preparatory ApproachOther
The experimental training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises followed a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e., catching a ball thrown by the therapist).
The control aquatic therapy consists of water-based exercises, in line with suggestions of the Hydrotherapy Association of Chartered Physiotherapists Guidance on Good Practice in Hydrotherapy.
These consisted of warm-up exercises, stretching exercises for the lower limbs, recruitment exercises and walking exercises during each phase of gait (single stance, swing and double stance).
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | 8 individual experimental rehabilitation sessions as outpatients (2 days/week, 4 weeks), in a rehabilitation pool at Fondazione Santa Lucia Neurorehabilitation hospital. Each session lasted 45minutes. The water temperature was between 30°C and 32°C. Receives: Other: Water-based Sequential Preparatory Approach |
| control | Active comparator | 8 individual of standard aquatic rehabilitation sessions as outpatients (2 days/week, 4 weeks), in a rehabilitation pool at Fondazione Santa Lucia Neurorehabilitation hospital. Each session lasted 45minutes. The water temperature was between 30°C and 32°C. Receives: Other: Water-based Sequential Preparatory Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Berg Balance Scale at 2 months
Change of Berg Balance Scale (BBS) from baseline at 2 months. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest
Measured: at 2 months
Secondary outcomes (4)
Stroke Specific Quality Of Life Scale (SS-QOL)
Change of Stroke Specific Quality Of Life Scale (SS-QOL) from baseline at 4 weeks of training and at 4 weeks after the end of the training. SS-QOL values ranging from 0 to 245, where 0 means the worse outcome and 245 the best one.
Measured: baseline, after 4 weeks of training, and 4 weeks after the end of training
Modified Barthel Index (MBI)
Change of Modified Barthel Index (MBI) from baseline at 4 weeks of training and at 4 weeks after the end of the training. MBI values ranging from 0 to 105, where 0 means the worse outcome and 105 the best one.
Measured: baseline, after 4 weeks of training, and 4 weeks after the end of training
Tinetti Balance and Gait Scale (TBG)
Change of Tinetti Balance and Gait Scale (TBG) from baseline at 4 weeks of training and at 4 weeks after the end of the training. TBG values ranging from 0 to 28, where 0 means the worse outcome and 28 the best one.
Measured: baseline, after 4 weeks of training, and 4 weeks after the end of training
Modified Ashworth Scale (MAS)
Change of Modified Ashworth Scale (MAS) from baseline at 4 weeks of the training and at 4 weeks after the end of the training. MAS values ranging from 0 to 5, where 0 means the best outcome and 5 the worse one.
Measured: baseline, after 4 weeks of training, and 4 weeks after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Feb 2019
- Primary completion30 Sep 2019
- Study completion30 Nov 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tramontano, I.R.C.C.S. Fondazione Santa Lucia
- Investigators
- Marco Tramontano, Principal investigator, Santa Lucia Foundation I.R.C.C.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362202
- Sponsor's protocol ID
- FSLCE/PROG.728
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 24 Apr 2020
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Water-based Sequential Preparatory Approach Versus Conventional Aquatic Training in Stroke Patients: a Randomized Controlled Trial With a One-month Follow-up
- ClinicalTrials.gov ID
- NCT04362202
- Acronym / sponsor ID
- FSLCE/PROG.728
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 24 Apr 2020 (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.
Many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living.
A Cochrane Review systematically synthesized and compared the effects of aquatic and land-based therapies on the activities of daily living (ADL) of patients following stroke and found that water-based exercises improved strength and ADL. A recent review indicates that RCTs comparing aquatic methods in both environments are lacking. The same movements in water and on dry land that target postural stability and gait require different competences. For example, the postural instability that occurs while squatting in water was enacted on land by sitting on a therapy ball. Furthermore, land-based conventional rehabilitation is generally task oriented, customized and challenging and follows a specific preparatory sequence of exercises according to patients' disabilities. Therefore, the investigators believe that a sequential preparatory approach (SPA), based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex), should also be used in an aquatic environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Water-based Sequential Preparatory Approach8 individual experimental rehabilitation sessions as outpatients (2 days/week, 4 weeks), in a rehabilitation pool at Fondazione Santa Lucia Neurorehabilitation hospital. Each session lasted 45minutes. The water temperature was between 30°C and 32°C. |
| control | Active comparator | Other: Water-based Sequential Preparatory Approach8 individual of standard aquatic rehabilitation sessions as outpatients (2 days/week, 4 weeks), in a rehabilitation pool at Fondazione Santa Lucia Neurorehabilitation hospital. Each session lasted 45minutes. The water temperature was between 30°C and 32°C. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke with unilateral hemiplegia within the previous six months;
- Ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance (Functional Ambulation Classification ≥ 3);
- Acclimatization to water.
Key exclusion criteria (11 listed)
- Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination > 24);
- Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
- Severe aphasia (diagnosed by means of neuropsychological assessment);
- Presence of other neurological diseases;
- Presence of cutaneous and mycosis infections;
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 |
|---|---|---|
| Water-based Sequential Preparatory ApproachThe experimental training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises followed a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e., catching a ball thrown by the therapist). The control aquatic therapy consists of water-based exercises, in line with suggestions of the Hydrotherapy Association of Chartered Physiotherapists Guidance on Good Practice in Hydrotherapy. These consisted of warm-up exercises, stretching exercises for the lower limbs, recruitment exercises and walking exercises during each phase of gait (single stance, swing and double stance). | Other | control, experimental |
Primary outcome
Change in Berg Balance Scale at 2 months
Time frame: at 2 months
Change of Berg Balance Scale (BBS) from baseline at 2 months. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest
4 secondary outcomes
Stroke Specific Quality Of Life Scale (SS-QOL)
Time frame: baseline, after 4 weeks of training, and 4 weeks after the end of training
Modified Barthel Index (MBI)
Time frame: baseline, after 4 weeks of training, and 4 weeks after the end of training
Tinetti Balance and Gait Scale (TBG)
Time frame: baseline, after 4 weeks of training, and 4 weeks after the end of training
Modified Ashworth Scale (MAS)
Time frame: baseline, after 4 weeks of training, and 4 weeks after the end of training
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 24 Apr 2020.
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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.
Marco Tramontano principal investigator
Santa Lucia Foundation I.R.C.C.S.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based Sequential Preparatory Approach in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
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 11 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 24 Apr 2020. 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 Italy. 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?
Change in Berg Balance Scale at 2 months (time frame: at 2 months). 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 24 Apr 2020; AzTrials last refreshed its copy on 4 Nov 2026.