Actively Recruiting
Led by Istituto Nazionale di Ricovero e Cura per Anziani · Updated on 2023-10-23
195
Participants Needed
2
Research Sites
N/A
Total Duration
Parkinson's disease is a common cause of disability in older adults, characterized by motor problems including balance issues that do not improve with standard dopaminergic treatments. This research aims to explore new rehabilitation methods using robotic devices to enhance gait and reduce fall risk in elderly patients with Parkinson's disease. The study is a single-blinded randomized controlled trial involving 195 patients, designed to assess the effectiveness of these innovative approaches. Participants will be randomly assigned to one of three groups: a control group receiving traditional rehabilitation therapy, a group using the Tymo system robotic device combined with traditional therapy, or a group using the Walker View robotic treadmill alongside traditional therapy. Each participant will complete 10 treatment sessions over 5 weeks, with two sessions per week. The control group will receive 50 minutes of traditional therapy per session, while the robotic groups will receive 30 minutes of traditional therapy plus 20 minutes with their assigned robotic device. Throughout the study, patients will be evaluated at the start, after treatment, and during follow-ups at 6 months, 1 year, and 2 years to monitor outcomes such as fall risk, gait performance, and fear of falling. Assessments include task-oriented exercises using robotic platforms and traditional therapy, with long-term monitoring to understand sustained effects. This approach supports understanding how robotic rehabilitation may influence motor function and safety in elderly Parkinson's patients over time.
CONDITIONS
Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive rehabilitation treatment involving either traditional therapy or robotic-assisted therapy using the Tymo system or Walker View robotic treadmill.
2 visits per week for 5 weeks (total 10 sessions)
Duration - 2 years
Participants are assessed to evaluate the long-term effects of the rehabilitation treatment on gait, balance, and risk of falling.
Assessments at 6 months, 1 year, and 2 years after treatment
Total: 2 locations
1
IRCCS INRCA Hospital
Ancona, Italy, 60131
Actively Recruiting
2
IRCCS INRCA Hospital
Fermo, Italy
Actively Recruiting
R
Roberta Bevilacqua
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Elvira Maranesi, Elisa Casoni, Renato Baldoni...
https://pubmed.ncbi.nlm.nih.gov/36429537Roberta Bevilacqua, Elvira Maranesi, Mirko Di Rosa...
https://pubmed.ncbi.nlm.nih.gov/32404132