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

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ClinicalTrials.gov Identifier: NCT01460277
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hemiplegics Procedure: Hydrokinesiotherapy Intervention Procedure: Land-based exercise intervention Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2011
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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

  7. 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)


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460277


Locations
Greece
University Hospital of Ioannina
Ioannina, Greece
Sponsors and Collaborators
University of Ioannina
Investigators
Principal Investigator: Avraam Ploumis University Hospital, Ioannina
More Information
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Responsible Party: Avraam Ploumis, Assistant Professor of PMR, Orthopaedic Spine Surgeon, University of Ioannina
ClinicalTrials.gov Identifier: NCT01460277     History of Changes
Other Study ID Numbers: 275/2011
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Avraam Ploumis, University of Ioannina:
hemiplegic
balance
hydrotherapy