Using robotic devices to improve rehabilitation for elderly patients with Parkinson's disease
Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
This study is testing whether using robotic devices during rehab can help older people with Parkinson's disease walk better and reduce their risk of falling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Istituto Nazionale di Ricovero e Cura per Anziani Academic / other |
| Locations | 2 sites (Ancona and 1 other locations) |
| Trial ID | NCT04087031 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a new rehabilitation approach for elderly patients with Parkinson's disease by incorporating robotic devices into traditional therapy. It will involve a single-blinded randomized controlled trial with 195 participants, who will be divided into three groups: one receiving traditional rehabilitation, another using the Tymo system, and the last using Walker View alongside traditional therapy. The study will assess the effectiveness of these interventions on gait improvement and fall risk reduction, with follow-ups planned to evaluate long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are elderly patients diagnosed with Parkinson's disease who are in stages 1-3 of the Hoehn and Yahr scale and have a functional ambulation classification of 2 or less.
Not a fit: Patients with severe cognitive impairment, other neurological diseases, or those unable to participate in follow-ups may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes and quality of life for elderly patients with Parkinson's disease.
How similar studies have performed: Previous studies have shown promising results using robotic rehabilitation in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ancona and 1 other locations
- IRCCS INRCA Hospital — Ancona, Italy (Recruiting)
- IRCCS INRCA Hospital — Fermo, Italy (Recruiting)
Study contacts
- Study coordinator: Roberta Bevilacqua
- Email: r.bevilacqua@inrca.it
- Phone: 00390718004767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.