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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04087031
Other study ID # INRCA_02_2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 3, 2019
Est. completion date December 31, 2026

Study information

Verified date October 2023
Source Istituto Nazionale di Ricovero e Cura per Anziani
Contact Roberta Bevilacqua
Phone 00390718004767
Email r.bevilacqua@inrca.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
control arm
Each session will include 50 minutes of traditional physical rehabilitation therapy
virtual reality games
Each 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
Each 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

Locations

Country Name City State
Italy IRCCS INRCA Hospital Ancona
Italy IRCCS INRCA Hospital Fermo

Sponsors (1)

Lead Sponsor Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Secondary 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 before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
Secondary 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) before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
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