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Completed

NCT Number: NCT01460277

Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

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.

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Key information

Conditions

Hemiplegics

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Ioannina

Ioannina, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrokinesiotherapy Intervention

Procedure

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 intervention

Procedure

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Acronym: hydro

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2011
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.