Exoskeleton for Parkinson's (NCT06028529)
Improve walking mobility using exoskeleton
- Trial ID
- NCT06028529
- Official Title
- Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease
- Goal
- Improve walking mobility using exoskeleton
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson's Disease
- Interventions
- Exoskeleton
Summary For Families
Goal: to see if a portable robotic exoskeleton can be worn safely and help people with Parkinson's improve walking, balance, and overall mobility. Approach: participants wear a wearable device (Keeogo) that actively assists hip and knee flexion and extension during walking, reducing effort and stabilizing steps, and it augments movement without changing Parkinson's medications like levodopa. Eligibility: veterans aged 18 to 90 with Parkinson's confirmed by a PADRECC specialist, modified Hoehn and Yahr stage II to V, who can attend visits at the Richmond VA and pass basic strength and walking screens. Key exclusions include severe heart or lung disease, significant dementia (MoCA under 17), very low bone density, lower limb amputation, certain implants, or body size outside 5'1",6'3" and over 250 pounds.
Locations
- Richmond VA Medical Center, Richmond, VA, Richmond, Virginia, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Exoskeleton. Goal: to see if a portable robotic exoskeleton can be worn safely and help people with Parkinson's improve walking, balance, and overall mobility. Approach: participants wear a wearable device (Keeogo) that actively assists hip and knee flexion and extension during walking, reducing effort and stabilizing steps, and it augments movement without changing Parkinson's medications like levodopa. Eligibility: veterans aged 18 to 90 with Parkinson's confirmed by a PADRECC specialist, modified Hoehn and Yahr stage II to V, who can attend visits at the Richmond VA and pass basic strength and walking screens. Key exclusions include severe heart or lung disease, significant dementia (MoCA under 17), very low bone density, lower limb amputation, certain implants, or body size outside 5'1",6'3" and over 250 pounds.
- Who can participate?
- Participants must be between 18 Years and 90 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.
- 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- You will come to the clinic twice weekly for eight weeks (16 total visits).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Surgical procedure (invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.