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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Ioannina
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01460277
First received: October 22, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Hemiplegics
Procedure: Hydrokinesiotherapy Intervention
Procedure: Land-based exercise intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change of balance at six weeks [ Time Frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks ] [ Designated as safety issue: No ]
    Berg Balance Score

  • Change of spasticity at six weeks [ Time Frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks ] [ Designated as safety issue: No ]
    with ashworth test

  • 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 ] [ Designated as safety issue: No ]
    6-stages Brunnstrom scale

  • Change of trunk control at 6 weeks [ Time Frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks ] [ Designated as safety issue: No ]
    Trunk Control Test (TCT)

  • Change of function at 6 weeks [ Time Frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks ] [ Designated as safety issue: No ]
    Functional Indepedence Measure (FIM)

  • 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 ] [ Designated as safety issue: No ]
    Motricity Index

  • Change of posture at 6 weeks [ Time Frame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks ] [ Designated as safety issue: No ]
    Postural Assessment Scale for Stroke Patient (PASS)


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460277

Contacts
Contact: Georgia Iatridou iatridou_g@yahoo.com

Locations
Greece
University Hospital of Ioannina Recruiting
Ioannina, Greece
Contact: Georgia Iatridou       iatridou_g@yahoo.com   
Principal Investigator: Avraam Ploumis         
Sub-Investigator: Georgia Iatridou         
Sponsors and Collaborators
University of Ioannina
Investigators
Principal Investigator: Avraam Ploumis University Hospital, Ioannina
  More Information

No publications provided

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
Study First Received: October 22, 2011
Last Updated: January 7, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Ioannina:
hemiplegic
balance
hydrotherapy

ClinicalTrials.gov processed this record on July 22, 2014