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?
- 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 2 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.