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

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: Completed
• Conditions: Hemiplegics
• Intervention / Treatment: Procedure: Hydrokinesiotherapy Intervention; Procedure: Land-based exercise intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Ioannina, Greece
    • University Hospital of Ioannina

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of postural and sitting balance at 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

Outcome Measure	Measure Description	Time Frame
Change of balance at 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	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	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	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	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	Motricity Index	At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Change of posture at 6 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

• Sponsor: University of Ioannina
• Investigators: Principal Investigator: Avraam Ploumis, University Hospital, Ioannina

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: October 22, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (ESTIMATE): October 26, 2011

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: balance; hemiplegic; hydrotherapy
• Other Study ID Numbers: 275/2011