Increase daily walking step count
- Trial ID
- NCT04848077
- Official Title
- STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life
- Goal
- Increase daily walking step count
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Radboud University Medical Center
- Study Type
- INTERVENTIONAL
- Enrollment
- 452 participants
- Conditions
- Movement Disorders, Parkinson Disease
- Interventions
- Step count increase with the use of a motivational smartphone application
Summary For Families
The goal is to help people with Parkinson's who walk relatively little increase their daily step count to boost mobility, fitness, and everyday function. The approach uses a motivational smartphone app that tracks steps and gives personalized, gradually increased step-count targets with reminders and feedback, so it nudges more walking in daily life without changing medications like levodopa. Adults with idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently, understand Dutch, and currently average under 7,000 steps per day are being enrolled. People with frequent recent falls, other mobility-limiting medical problems, cognitive issues that prevent app use, those living in nursing homes, or without a compatible smartphone are excluded.
Locations
- Radboud university medical center, Nijmegen, Gelderland, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Step count increase with the use of a motivational smartphone application. The goal is to help people with Parkinson's who walk relatively little increase their daily step count to boost mobility, fitness, and everyday function. The approach uses a motivational smartphone app that tracks steps and gives personalized, gradually increased step-count targets with reminders and feedback, so it nudges more walking in daily life without changing medications like levodopa. Adults with idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently, understand Dutch, and currently average under 7,000 steps per day are being enrolled. People with frequent recent falls, other mobility-limiting medical problems, cognitive issues that prevent app use, those living in nursing homes, or without a compatible smartphone are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 5 years and 3 months.
- 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.