HemiplegicshydroNCT01460277
Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients
A study testing Hydrokinesiotherapy Intervention and Land-based exercise intervention in people with Hemiplegics, run by University of Ioannina at 1 site in Greece.
Trial summary
The purpose of this current prospective study is to assess and compare the effects of a hydrotherapy exercise programme against a conventional land-based exercise programme in individuals with hemiplegia. Both exercise interventions aim at improving posture, balance and weight-bearing capability. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hemiplegics
- What is being tested?
- Hydrokinesiotherapy Intervention and Land-based exercise intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2011to Oct 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemiplegia or hemiparesis after stroke or traumatic brain injury
- at least 6 months post-stroke from a single cerebrovascular accident
- independent in walking (with or without assistive device)
- clinical stable
Who cannot join
- unstable cardiac conditions
- epilepsy
- urinary or faecal incontinence
- open wounds
- significant musculoskeletal problems in lower extremities from conditions other than stroke
- Alzheimer
Show all 10Show fewer
- Parkinson's disease
- polyneuropathy
- vestibular disorders
- current participation in an exercise program
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this current prospective study is to assess and compare the effects of a hydrotherapy exercise programme against a conventional land-based exercise programme in individuals with hemiplegia. Both exercise interventions aim at improving posture, balance and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and >60 years). The physical examination consisted of (1) a lower-limb motor function recovery of the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional status measured with the Functional Independence Measure. Postural sway was evaluated with a pressure platform by using the variables of center of pressure (COP) displacements in the mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and evaluated using statistical programme SPSS.
- Conditions
- Hemiplegics
- Being tested
- Hydrokinesiotherapy Intervention, Land-based exercise intervention
- Keywords
- hemiplegic, balance, hydrotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrokinesiotherapy InterventionProcedure or surgery
The hydrotherapy exercise intervention consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (water walking, running, side stepping), 5 minutes of a light cool down (marching on the spot), and 10 minutes of gentle stretching in the water.
Land-based exercise interventionProcedure or surgery
The conventional exercise intervention used no water-based exercises but land-based exercises. The exercise program consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (walking, side stepping), 5 minutes of a light cool down, and 10 minutes of gentle stretching out of the water.
| Study group | Role | What they receive |
|---|---|---|
| Hydrokinesiotherapy | Experimental | A 6-week water-based exercise program that focused on balance and weight bearing exercises (3 days a week for 1 hour a session) Receives: Procedure: Hydrokinesiotherapy Intervention |
| Conventional exercise intervention | Active comparator | A 6-week land-based exercise program that focused on balance and weight bearing exercises (3 days a week for 1 hour a session) Receives: Procedure: Land-based exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of postural and sitting balance at six weeks
Postural balance and weight-bearing ability measured by vertical ground reaction force during standing, sitting and four standing tasks (rising from a chair and weight-shifting forward, backward and laterally)
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Secondary outcomes (7)
Change of balance at six weeks
Berg Balance Score
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of spasticity at six weeks
with ashworth test
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of leg's strength at 6 weeks
6-stages Brunnstrom scale
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of trunk control at 6 weeks
Trunk Control Test (TCT)
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of function at 6 weeks
Functional Indepedence Measure (FIM)
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of leg's motion at 6 weeks
Motricity Index
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of posture at 6 weeks
Postural Assessment Scale for Stroke Patient (PASS)
Measured: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiplegicsStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
- Investigators
- Avraam Ploumis, Principal investigator, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460277
- Sponsor's protocol ID
- 275/2011
- Acronym
- hydro
- Status last verified
- Jul 2019
- First submitted
- 22 Oct 2011
- Last updated
- 15 Jul 2019
- Results posted
- No
Publications
Iatridou G, Stergiou AN, Varvarousis DN, Theodorou A, Doulgeri S, Pelidou HS, Dimakopoulos G, Ploumis A. Comparative Study Between Aquatic Therapy and Land-Based Exercises in Hemiplegic Patients After Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):305-311. doi: 10.1097/PHM.0000000000002589. Epub 2024 Jul 2.
PubMed 38954645
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT01460277
- Acronym / sponsor ID
- hydro / 275/2011
- Conditions
- Hemiplegics
- Keywords
- hemiplegic, balance, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Oct 2011 (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 purpose of this current prospective study is to assess and compare the effects of a hydrotherapy exercise programme against a conventional land-based exercise programme in individuals with hemiplegia. Both exercise interventions aim at improving posture, balance and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and >60 years). The physical examination consisted of (1) a lower-limb motor function recovery of the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional status measured with the Functional Independence Measure. Postural sway was evaluated with a pressure platform by using the variables of center of pressure (COP) displacements in the mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and evaluated using statistical programme SPSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrokinesiotherapy | Experimental | Procedure: Hydrokinesiotherapy InterventionA 6-week water-based exercise program that focused on balance and weight bearing exercises (3 days a week for 1 hour a session) |
| Conventional exercise intervention | Active comparator | Procedure: Land-based exercise interventionA 6-week land-based exercise program that focused on balance and weight bearing exercises (3 days a week for 1 hour a session) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hemiplegia or hemiparesis after stroke or traumatic brain injury
- at least 6 months post-stroke from a single cerebrovascular accident
- independent in walking (with or without assistive device)
- clinical stable
Key exclusion criteria (10 listed)
- unstable cardiac conditions
- epilepsy
- urinary or faecal incontinence
- open wounds
- significant musculoskeletal problems in lower extremities from conditions other than stroke
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 |
|---|---|---|
| Hydrokinesiotherapy InterventionThe hydrotherapy exercise intervention consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (water walking, running, side stepping), 5 minutes of a light cool down (marching on the spot), and 10 minutes of gentle stretching in the water. | Procedure or surgery | Hydrokinesiotherapy |
| Land-based exercise interventionThe conventional exercise intervention used no water-based exercises but land-based exercises. The exercise program consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (walking, side stepping), 5 minutes of a light cool down, and 10 minutes of gentle stretching out of the water. | Procedure or surgery | Conventional exercise intervention |
Primary outcome
Change of postural and sitting balance at six weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Postural balance and weight-bearing ability measured by vertical ground reaction force during standing, sitting and four standing tasks (rising from a chair and weight-shifting forward, backward and laterally)
7 secondary outcomes
Change of balance at six weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of spasticity at six weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of leg's strength at 6 weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of trunk control at 6 weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of function at 6 weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of leg's motion at 6 weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of posture at 6 weeks
Time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
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 15 Jul 2019.
- Derived from this study: PubMed 38954645Iatridou G, Stergiou AN, Varvarousis DN, Theodorou A, Doulgeri S, Pelidou HS, Dimakopoulos G, Ploumis A. Comparative Study Between Aquatic Therapy and Land-Based Exercises in Hemiplegic Patients After Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):305-311. doi: 10.1097/PHM.0000000000002589. Epub 2024 Jul 2.
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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.
Avraam Ploumis principal investigator
University Hospital, Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrokinesiotherapy Intervention and Land-based exercise intervention in people with Hemiplegics, run by University of Ioannina at 1 site in Greece.
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 10 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 15 Jul 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 Greece. 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 of postural and sitting balance at six weeks (time frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460277, which also lists 1 linked publication.
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 15 Jul 2019.