Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

NCT01460277 | Completed

• 1 other identifier: 275/2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegics

Keywords

hemiplegic; balance; hydrotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of balance at six 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

• Change of trunk control at 6 weeks

  At the time of admittance to the rehabilitation department (at baseline) and after six weeks

• Change of function at 6 weeks

  At the time of admittance to the rehabilitation department (at baseline) and after six weeks

Study Arms (2)

Hydrokinesiotherapy

EXPERIMENTAL

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

Conventional exercise intervention

ACTIVE COMPARATOR

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

Interventions

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.

Hydrokinesiotherapy

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.

Conventional exercise intervention

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece

Location

Related Publications (1)

• Iatridou G, Stergiou AN, Varvarousis DN, Theodorou A, Doulgeri S, Pelidou HS, Dimakopoulos G, Ploumis A. Comparative Study Between Aquatic Therapy and Land-Based Exercises in Hemiplegic Patients After Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):305-311. doi: 10.1097/PHM.0000000000002589. Epub 2024 Jul 2.

  PMID: 38954645 DERIVED

Study Officials

• Avraam Ploumis

  University Hospital, Ioannina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of PMR, Orthopaedic Spine Surgeon

Study Record Dates

• First Submitted: October 22, 2011
• First Posted: October 26, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

GR (1)