Clinical trial NCT01460277: Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegics
Keywords: hemiplegic
balance
hydrotherapy
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of postural and sitting balance at six weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Secondary outcomes:
measure: Change of balance at six weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
measure: Change of spasticity at six weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
measure: Change of leg's strength at 6 weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
measure: Change of trunk control at 6 weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
measure: Change of function at 6 weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
measure: Change of leg's motion at 6 weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
measure: Change of posture at 6 weeks
timeFrame: At the time of admittance to the rehabilitation department (at baseline) and after six weeks
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
Study officials:
affiliation: University Hospital, Ioannina
name: Avraam Ploumis
role: PRINCIPAL_INVESTIGATOR
References: