Detect walking and balance problems
- Trial ID
- NCT07281794
- Official Title
- Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
- Goal
- Detect walking and balance problems
- Status
- RECRUITING
- Sponsor
- Northumbria University
- Study Type
- OBSERVATIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease (PD), Healthy (Controls)
Summary For Families
The goal is to see whether the DANU Sports System can accurately detect and quantify gait and balance problems in people with Parkinson's, so assessments become more objective and reliable. The approach uses wearable sensors during short walking and standing tests to record step timing, stride length, gait variability and postural sway, and compares those measurements to healthy controls to test clinical validity. The study enrolls adults aged 50 and over, people with Parkinson's at Hoehn and Yahr stages I to III diagnosed by a movement disorder specialist who can stand and walk unassisted for at least two minutes and have a MoCA score of 21 or higher, and similar-age healthy controls without neurologic or major musculoskeletal issues.
Locations
- Northumbria University, Newcastle upon Tyne, Tyne and Wear, United Kingdom
- Northumbria University, Newcastle upon Tyne, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to see whether the DANU Sports System can accurately detect and quantify gait and balance problems in people with Parkinson's, so assessments become more objective and reliable. The approach uses wearable sensors during short walking and standing tests to record step timing, stride length, gait variability and postural sway, and compares those measurements to healthy controls to test clinical validity. The study enrolls adults aged 50 and over, people with Parkinson's at Hoehn and Yahr stages I to III diagnosed by a movement disorder specialist who can stand and walk unassisted for at least two minutes and have a MoCA score of 21 or higher, and similar-age healthy controls without neurologic or major musculoskeletal issues.
- Who can participate?
- Participants must be at least 50 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 2 years and 1 month.
- 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.