Parkinson's Trial NCT05874739
Validate wearable assessment of walking
- Trial ID
- NCT05874739
- Official Title
- Validating a Digital Mobility Assessment in Parkinson's Disease Using Wearable Technology - the Mobilise-D Extension Study.
- Goal
- Validate wearable assessment of walking
- Status
- RECRUITING
- Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study Type
- OBSERVATIONAL
- Enrollment
- 651 participants
- Conditions
- Parkinson Disease, Aging
Summary For Families
Mobilise-D's extension aims to validate a digital mobility assessment, to see if wearable sensors can reliably capture everyday walking and balance changes in people with Parkinson's and in older adults. Participants wear a small sensor that records steps, gait speed, stride length, turning and activity patterns in real life, so researchers can compare those objective measures with clinical ratings and track mobility over time. The study is looking for two groups: older control volunteers aged 50 and over who can walk 4 meters unaided and are willing to wear a sensor for about 12 months, and people with Parkinson's already enrolled in the Mobilise-D clinical validation cohort, aged 18 and over with Hoehn and Yahr stages I to III. People with recent major cardiac events, active cancer, dementia, or other neurological or orthopedic conditions that significantly affect walking are excluded.
Locations
- The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Mobilise-D's extension aims to validate a digital mobility assessment, to see if wearable sensors can reliably capture everyday walking and balance changes in people with Parkinson's and in older adults. Participants wear a small sensor that records steps, gait speed, stride length, turning and activity patterns in real life, so researchers can compare those objective measures with clinical ratings and track mobility over time. The study is looking for two groups: older control volunteers aged 50 and over who can walk 4 meters unaided and are willing to wear a sensor for about 12 months, and people with Parkinson's already enrolled in the Mobilise-D clinical validation cohort, aged 18 and over with Hoehn and Yahr stages I to III. People with recent major cardiac events, active cancer, dementia, or other neurological or orthopedic conditions that significantly affect walking 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?
- 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 2 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 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?
- PD participants will attend a single follow-up visit 36 months after their initial CVS baseline visit; control participants will attend a baseline visit and a 12-month follow-up visit.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Thinking & memory tests (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.