Parkinson Disease
Conditions
Keywords
Parkinson Disease, Mobility, Balance, Virtual Reality, treadmill training
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
Interventions
BEHAVIORALVirtual Reality
12 sessions of 1 hour (30 min of virtual reality and 30 min of aerobic exercise with treadmill training): three times a week over four weeks
BEHAVIORALConventional Therapy
12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-Minute Walking Test | 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
| Measure | Time frame | Description |
|---|---|---|
| Time Up and Go Test | weeks: 0,4, 16 | Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch. |
| 10 meter walk test | weeks: 0,4, 16 | Assesses walking speed in meters per second over a short duration |
| Berg Balance Scale | weeks: 0,4, 16 | This is an assessment scale of ability to maintain balance, or statically or while performing functional movement, including 14 observable tasks common to everyday life measured on a 5 point ordinal scale. |
| Postural sway (Center of pressure (COP) trajectories) | weeks: 0,4, 16 | Center of pressure (COP) trajectories |
| Metabolic measurements by Near infrared spectroscopy | weeks: 0,4, 16 | Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks |
| Unified Parkinson's Disease Rating Scale | weeks: 0,4, 16 | It is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease across the longitudinal disease course and provide a clinical endpoint in therapy trials. |
Countries
Italy
Contacts
Primary ContactSofia Straudi, MD
Outcome results
None listed