play-based rehabilitaion for Parkinson's (NCT04720365)
Improve gait and balance remotely
- Trial ID
- NCT04720365
- Official Title
- Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
- Goal
- Improve gait and balance remotely
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Rouen
- Study Type
- INTERVENTIONAL
- Enrollment
- 80 participants
- Conditions
- Patients With Parkinson's Disease
- Interventions
- play-based rehabilitaion
Summary For Families
The goal is to reduce falls and improve walking and balance in people with Parkinson's whose gait and balance problems do not get better with levodopa. At home, participants use interactive serious games that guide repetitive balance and walking exercises, give real-time feedback and motivation, and aim to retrain posture and stepping patterns; this is a non-drug add-on and medications like levodopa are kept unchanged. Eligible people are adults 18 and older with idiopathic Parkinson's who still have gait or freezing despite levodopa, have had at least two falls in the past year, have stable Parkinson medications and an internet connection at home, while those with severe immobility, moderate to severe dementia, no internet, or other major exclusions are not eligible.
Locations
- Chu Bordeaux, Bordeaux, France
- Chu Lille, Lille, France
- Gh Pitie Salpetriere, Paris, France
- Rouen University Hospital, Rouen, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying play-based rehabilitaion. The goal is to reduce falls and improve walking and balance in people with Parkinson's whose gait and balance problems do not get better with levodopa. At home, participants use interactive serious games that guide repetitive balance and walking exercises, give real-time feedback and motivation, and aim to retrain posture and stepping patterns; this is a non-drug add-on and medications like levodopa are kept unchanged. Eligible people are adults 18 and older with idiopathic Parkinson's who still have gait or freezing despite levodopa, have had at least two falls in the past year, have stable Parkinson medications and an internet connection at home, while those with severe immobility, moderate to severe dementia, no internet, or other major exclusions are not eligible.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 4 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 6 years.
- 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?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Assessments at inclusion, at 6 months, and at 12 months (over 12 months).