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Clinical Trials/NCT01460277
NCT01460277
Completed
Not Applicable

Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

University of Ioannina1 site in 1 country60 target enrollmentOctober 2011
ConditionsHemiplegics

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegics
Sponsor
University of Ioannina
Enrollment
60
Locations
1
Primary Endpoint
Change of postural and sitting balance at six weeks
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
October 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

University of Ioannina

Eligibility 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
  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Change of function at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of balance at six weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of trunk control at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of leg's motion at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of posture at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of spasticity at six weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)
  • Change of leg's strength at 6 weeks(At the time of admittance to the rehabilitation department (at baseline) and after six weeks)

Study Sites (1)

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