Parkinson Disease Clinical Trial
Official title:
Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
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.
Status | Recruiting |
Enrollment | 195 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Hoen and Yahr scale: 1-3 stage - FAC = 2 - Ranking scale score = 3 - Stability of drug treatment for at least 1 month - Geriatric Depression Scale 5-items: negative Exclusion Criteria: - 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 - Serious dysfunction of the autonomic system - Severe behavioral syndromes not compensated by drugs - Concurrent neurological diseases - Severe systemic diseases with life expectancy < 1 year - Patients unable to follow up. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS INRCA Hospital | Ancona | |
Italy | IRCCS INRCA Hospital | Fermo |
Lead Sponsor | Collaborator |
---|---|
Istituto Nazionale di Ricovero e Cura per Anziani |
Italy,
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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