Remote Haptic Rehabilitation for Parkinson's Disease
Purpose
Individuals with Parkinson's Disease (PD) often have motor difficulties that can negatively impact daily activities and their quality of life. Research has shown that to slow the progression of these symptoms, patients should partake in effective physical rehabilitation. However, effective physical rehabilitation has many barriers, including timing, cost, and other personal or system-level challenges. The purpose of this study is to evaluate the haptic remote rehabilitation system for patients with PD using a randomized controlled trial (RCT) in a field environment.
Condition
- Parkinson's Disease (PD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Over 18 years old - Diagnosed with PD
Exclusion Criteria
- Hoehn and Yahr stage outside 1-3 - Lives outside the 48 contiguous states in the USA - Unable to move hands and head without assistance - Unable to remain seated in an upright position for up to an hour
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- In this study, the investigator will randomly assign participants to either the haptic group (intervention) or the non-haptic group (sham comparator). Both participants will receive a similar handheld device and will perform selected exercise tasks. The haptic (intervention) group will receive haptic feedback through the device. The non-haptic (sham comparator) group will not receive any haptic feedback. However, both devices will be identical in nature. Participants will remain in their assigned group throughout the study.
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
- Masking Description
- Participants will be blindly assigned to one of the groups to reduce bias.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Haptic group |
Participants will receive a handheld device that can provide haptic feedback to guide them in performing different movement tasks. Each participant will be asked to participate in sessions lasting up to one hour, twice/week, for an 8-week period. Participants will be asked to perform typical upper-body movement tasks performed in rehabilitation sessions based on their functional capabilities. This includes "Full Extension Circles", "Shoulder Press", "Full Lateral Movement", and "Random Target Matching" activity. The haptic device will provide directional guidance to support the participants in completing these movement tasks. |
|
|
Sham Comparator Non-haptic group |
Participants will receive a handheld device similar to the haptic group. However, this device will not provide any haptic feedback. Each participant will be asked to participate in sessions lasting up to one hour, twice/week, for an 8-week period. Participants will be asked to perform typical upper-body movement tasks performed in rehabilitation sessions based on their functional capabilities. This includes "Full Extension Circles", "Shoulder Press", "Full Lateral Movement", and "Random Target Matching" activity. Participants will be asked to hold the handheld device during the tasks; however, they will not receive any haptic feedback from the device. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Virginia Polytechnic Institute and State University
Detailed Description
Parkinson's disease (PD) is a progressive disorder that affects the central nervous system, causing unintended or uncontrollable movements. PD is the second most common neurodegenerative disease, affecting 1-2 per 1000 of the population. This prevalence has more than doubled from 2.5 million patients in 1990 to 6.1 million patients in 2016. Upcoming shifts toward an aging population will exacerbate this problem and the healthcare burden. People with PD suffer from diverse motor symptoms (e.g., tremors, rigidity, and dystonia) that adversely affect their daily activities and quality of life. Physical rehabilitation can improve motor symptoms by slowing disease progression, thereby enhancing the well-being of those with PD. However, administering physical rehabilitation in an accessible and affordable way has been quite challenging because of person- and system-level barriers to healthcare services. Visits to physical therapists, in particular, require resources supported by a caregiver and one-on-one time with specialists, both of which are costly. These problems are especially prominent for patients in rural areas, thereby serving as a major barrier to equity in access to public health assets. At-home, technology-based rehabilitation programs could reduce training costs and enhance training accessibility, such as by removing the need for a PD patient to visit a facility in person or to schedule one-on-one therapist time. In particular, patients have responded positively to remote rehabilitation programs (e.g., through Zoom) as an alternative to in-person therapy. As these remote programs do not require special equipment other than a device for video-conferencing software, they are more accessible to broad user populations. Yet, such remote programs lack important components of usual physical rehabilitation - especially motion guidance, assessment, and feedback - during which critical communications are needed between the therapist and patient that include hands-on interactions. Also, such programs still require one-on-one therapist time, which can be costly and not affordable for long-term participation. To overcome such problems, rehabilitation systems using emerging technologies have been explored, including robotics and virtual reality (VR). Current robotics systems, though, are limited to clinical use due to their cost and size. VR-based rehabilitation programs can be good alternatives, but are still expensive and cumbersome to use, and they can cause motion sickness for PD patients. There is thus a clear need for remote rehabilitation programs that are effective, low-cost, easy to use, provide hands-on assistance, and ensure the safety of PD patients.