NCT02516644
Unknown
Not Applicable
Feasibility and Effectiveness of Virtual Reality and the Use of Body Weight Support Treadmill Training in Parkinson's Disease: an Explorative Study
University Hospital of Ferrara1 site in 1 country20 target enrollmentFebruary 2015
ConditionsParkinson Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University Hospital of Ferrara
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Six-Minute Walking Test
- Last Updated
- 8 years ago
Overview
Brief Summary
The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease
Investigators
Eligibility Criteria
Inclusion Criteria
- •idiopathic Parkinson Disease diagnosis
- •age under 80 years
- •severity of disease rated 2 or 3 at Hoehn \& Yahr scale
Exclusion Criteria
- •impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
- •neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
- •severe Levodopa dyskinesia
- •pregnancy
Outcomes
Primary Outcomes
Six-Minute Walking Test
Time Frame: up to weeks 16
The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary.
Secondary Outcomes
- Berg Balance Scale(weeks: 0,4, 16)
- Time Up and Go Test(weeks: 0,4, 16)
- 10 meter walk test(weeks: 0,4, 16)
- Unified Parkinson's Disease Rating Scale(weeks: 0,4, 16)
- Postural sway (Center of pressure (COP) trajectories)(weeks: 0,4, 16)
- Metabolic measurements by Near infrared spectroscopy(weeks: 0,4, 16)
Study Sites (1)
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