Multimodal Exercise Program with G… for Parkinson's (NCT06538298)
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?
- 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 Phase 1 trial is estimated to last approximately 1 year and 8 months.
- 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?
- The study is described as an 8-week pilot study; participants in the exercise group are asked to attend sessions three times per week for 6 weeks, each session lasting 60 minutes.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.