Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

NCT ID: NCT01460277

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Hydrokinesiotherapy Intervention

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

Land-based exercise intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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
• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ioannina

OTHER

Sponsor Role: lead

Responsible Party

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avraam Ploumis

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ioannina

Locations

University Hospital of Ioannina

Ioannina, , Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 38954645 (View on PubMed)

Other Identifiers

275/2011

Identifier Type: -

Identifier Source: org_study_id