Improve walking with robotic treadmill
- Trial ID
- NCT04087031
- Official Title
- Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
- Goal
- Improve walking with robotic treadmill
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Study Type
- INTERVENTIONAL
- Enrollment
- 195 participants
- Conditions
- Parkinson Disease, Frail Elderly, Robotic Devices in Rehabilitation
- Interventions
- control arm, virtual reality games, robotic treadmill
Summary For Families
The goal is to help frail older people with Parkinson's improve walking, balance, and independence, and to reduce falls and mobility-related dependence. The approach uses a robotic treadmill that supports and guides walking while interactive virtual reality games prompt stepping, weight shifts, and cognitive engagement to retrain gait patterns and build endurance; participants keep their usual Parkinson's medications but must have a stable drug regimen for at least one month. Looking for people 65 and older with mild to moderate Parkinson's, Hoehn and Yahr stage 1 to 3, reduced walking ability, ability to give consent, and no severe dementia or uncontrolled cardiac, autonomic, seizure, or other serious illnesses.
Locations
- IRCCS INRCA Hospital, Ancona, Italy
- IRCCS INRCA Hospital, Fermo, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying control arm. The goal is to help frail older people with Parkinson's improve walking, balance, and independence, and to reduce falls and mobility-related dependence. The approach uses a robotic treadmill that supports and guides walking while interactive virtual reality games prompt stepping, weight shifts, and cognitive engagement to retrain gait patterns and build endurance; participants keep their usual Parkinson's medications but must have a stable drug regimen for at least one month. Looking for people 65 and older with mild to moderate Parkinson's, Hoehn and Yahr stage 1 to 3, reduced walking ability, ability to give consent, and no severe dementia or uncontrolled cardiac, autonomic, seizure, or other serious illnesses.
- Who can participate?
- Participants must be at least 65 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 7 years and 1 month.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.