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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | Xbox Kinect + treadmill training |
|
| Conventional Therapy | Active Comparator | Specific conventional training for Parkinson's Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Behavioral | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Six-Minute Walking Test | 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. | up to weeks 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | 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. | weeks: 0,4, 16 |
| Time Up and Go Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Straudi, MD | Contact | +390532238720 | s.straudi@ospfe.it |
| Name | Affiliation | Role |
|---|---|---|
| Sofia Straudi, MD | Ferrara Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferrara University Hospital | Recruiting | Ferrara | 44124 | Italy |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Conventional Therapy | Behavioral | 12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks |
|
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. |
| weeks: 0,4, 16 |
| 10 meter walk test | Assesses walking speed in meters per second over a short duration | weeks: 0,4, 16 |
| Unified Parkinson's Disease Rating Scale | 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. | weeks: 0,4, 16 |
| Postural sway (Center of pressure (COP) trajectories) | Center of pressure (COP) trajectories | weeks: 0,4, 16 |
| Metabolic measurements by Near infrared spectroscopy | 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 | weeks: 0,4, 16 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |