Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

Hemiplegics Clinical Trial

— hydro  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460277
• Other study ID #: 275/2011
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: October 2016

Study information

• Verified date: July 2019
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegics

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of balance at six weeks	Berg Balance Score	At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Secondary	Change of spasticity at six weeks	with ashworth test	At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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