About this trial
The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hoen and Yahr scale: 1-3 stage
FAC ≤ 2
Ranking scale score ≤ 3
Stability of drug treatment for at least 1 month
Disqualifiers
Concomitant participation in other studies
Lack of written informed consent
Clinical dementia rating (CDR) score ≥ 3
History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically
Trial design
Parallel
Treatments tested in this trial
control arm
Other interventionEach session will include 50 minutes of traditional physical rehabilitation therapy
virtual reality games
Other interventionEach session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Tymo system (Tyromotion, Austria), a wireless static and dynamic platform, for evaluating and rehabilitating posture.
robotic treadmill
Other interventionEach session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Walker View (TecnoBody, Italy) a treadmill equipped with a sensorized belt with eight load cells and a 3D camera
Treatment groups
Trial outcomes
Primary outcomes
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score \< 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk.
Secondary outcomes
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
gait performance will be assessed by walking speed through instrumental Gait Analysis
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
fear of falling will be evaluated by the Falls Efficacy Scale - International (FES-I). Higher scores represent greater the fear of falling (ranging from 16 to 64)
Sponsors and contacts
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