Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients (hydro)

July 12, 2019 updated by: Avraam Ploumis, University of Ioannina
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Ioannina, Greece
        • University Hospital of Ioannina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • unstable cardiac conditions
  • epilepsy
  • urinary or faecal incontinence
  • open wounds
  • significant musculoskeletal problems in lower extremities from conditions other than stroke
  • Alzheimer
  • Parkinson's disease
  • polyneuropathy
  • vestibular disorders
  • current participation in an exercise program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Hydrokinesiotherapy
A 6-week water-based exercise program that focused on balance and weight bearing exercises (3 days a week for 1 hour a session)
Procedure: Hydrokinesiotherapy Intervention
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.
ACTIVE_COMPARATOR: Conventional exercise intervention
A 6-week land-based exercise program that focused on balance and weight bearing exercises (3 days a week for 1 hour a session)
Procedure: Land-based exercise intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
At the time of admittance to the rehabilitation department (at baseline) and after six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of balance at six weeks
Time Frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Berg Balance Score
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
with ashworth test
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
6-stages Brunnstrom scale
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
Trunk Control Test (TCT)
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
Functional Indepedence Measure (FIM)
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
Motricity Index
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
Postural Assessment Scale for Stroke Patient (PASS)
At the time of admittance to the rehabilitation department (at baseline) and after six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ioannina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Avraam Ploumis, University Hospital, Ioannina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 275/2011

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