Hemiplegics Clinical Trial
— hydroNCT number | NCT01460277 |
Other study ID # | 275/2011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | October 2016 |
Verified date | July 2019 |
Source | University of Ioannina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Ioannina | Ioannina |
Lead Sponsor | Collaborator |
---|---|
University of Ioannina |
Greece,
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 |