control arm for Parkinson's (NCT04087031)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 7 years and 1 month.
- 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.
- 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.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- Assessments are performed at baseline, at the end of treatment, and at 6 months, 1 year and 2 years from the end of the treatment.