Improve balance using gamified exercise
- Trial ID
- NCT06538298
- Official Title
- A Multimodal Exercise Program With Gamification (MEP+G) in Individuals With Parkinson Disease: a Pilot Randomized Controlled Trial
- Goal
- Improve balance using gamified exercise
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- California State University, Northridge
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson Disease
- Interventions
- Multimodal Exercise Program with Gamification
Summary For Families
The goal is to see if a structured, multimodal exercise program with game-like features can improve mobility, balance, endurance, and daily function in people with Parkinson's, possibly lowering fall risk and easing symptom burden. The program combines aerobic, strength, balance, and flexibility exercises with gamification elements like interactive feedback and challenges to boost motivation and adherence, and it aims to strengthen muscles and support brain circuits involved in movement as a complement to medications like levodopa, not a replacement. Eligible participants are adults 40 to 80 with idiopathic Parkinson's at Hoehn and Yahr stages 1,3 who can walk and stand for 10 minutes, have stable Parkinson's meds for at least 3 months, can get medical clearance and travel to the site, and who are not already doing more than 60 minutes per week of moderate to vigorous exercise, in Rock Steady boxing, living with another neurological disease, or within 3 months of deep brain stimulation.
Locations
- Equilibrium Physical Therapy, Ventura, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Multimodal Exercise Program with Gamification. The goal is to see if a structured, multimodal exercise program with game-like features can improve mobility, balance, endurance, and daily function in people with Parkinson's, possibly lowering fall risk and easing symptom burden. The program combines aerobic, strength, balance, and flexibility exercises with gamification elements like interactive feedback and challenges to boost motivation and adherence, and it aims to strengthen muscles and support brain circuits involved in movement as a complement to medications like levodopa, not a replacement. Eligible participants are adults 40 to 80 with idiopathic Parkinson's at Hoehn and Yahr stages 1,3 who can walk and stand for 10 minutes, have stable Parkinson's meds for at least 3 months, can get medical clearance and travel to the site, and who are not already doing more than 60 minutes per week of moderate to vigorous exercise, in Rock Steady boxing, living with another neurological disease, or within 3 months of deep brain stimulation.
- Who can participate?
- Participants must be between 40 Years and 80 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 Phase 1 trial is estimated to last approximately 1 year and 8 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.