Parkinson's Trial NCT07281794
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?
- 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 2 years and 1 month.
- 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 is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- One in-person visit to Northumbria University, Newcastle Upon Tyne.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.