An interventional study of Haptic device and Non-haptic device in Parkinson's Disease (PD), sponsored by Virginia Polytechnic Institute and State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Prevention
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
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.
Device: Haptic device
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.
Device: Non-haptic device
Participants will receive a custom-made handheld haptic device, which will be used to perform selected movement tasks. The device can generate the feeling of directional feedback.
Participants will receive a handheld device similar to the haptic group. However, the device in this intervention will not provide any haptic feedback.
System Usability Scale (SUS)
This scale evaluates participants' perceived usability of the device and the haptic feedback. It consists of 10 items, each scored on a 5-point Likert scale (0-4). The total raw score is converted to a scale of 0-100. A higher score will indicate better usability. A score of 68 is considered average usability. Scores above 68 reflect above average usability, while scores below 68 reflect below-average usability.
Time frame: At the end of the trial in week 8
Arm movement accuracy, speed, and smoothness
Each handheld device (both with and without haptic) are equipped with Intertial Measurement Units (IMUs). The data from the IMUs will be used to measure the movement accuracy, speed, and smoothness of the arm. Data recording will start during enrollment as baseline. Whenever participants complete any sessions during the 8-week trial period, data from the IMUs will be recorded to calculate movement accuracy, speed, and smoothness. We will compare these measures across the trial period to determine performance changes in the participants.
Time frame: From enrollment to the end of intervention at 8 weeks
Outcome Expectations of Exercise Scale (OEES)
This scale evaluates participants' expectations about exercise outcomes, including both perceived benefits and perceived negative consequences. It consists of 13 statements rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Items can be summarized as two subscales: positive outcome expectations (9 items; e.g., improved mood, strength, endurance) and negative outcome expectations (4 items; e.g., avoiding exercise due to shortness of breath, pain, fear of falling, or perceived cardiac stress). For scoring, item ratings are typically summed and divided by the number of items answered to yield a mean score ranging from 1 to 5. Higher scores indicate stronger outcome expectations. Higher positive-subscale scores reflect greater perceived benefits of exercise, whereas higher negative-subscale scores reflect stronger negative expectations/avoidance concerns about exercise.
Time frame: At the end of the trial in week 8
Self-Efficacy Scale (SES)
This scale evaluates participants' confidence in their ability to engage in regular physical activity and to overcome common barriers to exercise. It consists of 5 items rated on a 4-point Likert scale from 1 (not at all true) to 4 (exactly true). Items reflect perceived capability to persist with exercise, find ways to be active, achieve exercise goals, and manage barriers (e.g., fatigue or other challenges). For scoring, item ratings are typically summed (range: 5-20) or averaged (range: 1-4). Higher scores indicate greater exercise-related self-efficacy (i.e., stronger confidence in one's ability to be physically active despite obstacles).
Time frame: At the end of the trial in week 8
Parkinson's Disease Questionnaire (PDQ-8)
This questionnaire includes 8 items representing key domains impacted by Parkinson's disease (mobility, activities of daily living, emotional well-being, stigma, social support/relationships, cognition/concentration, communication, and bodily discomfort). Each item asks how often the participant experienced a problem "during the last month" and is rated on a 5-point response scale: Never, Occasionally, Sometimes, Often, and Always or cannot do at all, and scored from 0 to 4. Item scores are summed to produce a raw total (range: 0-32), which is converted to a 0-100 summary index by dividing by the maximum possible score and multiplying by 100. Higher PDQ-8 scores indicate worse health-related quality of life (i.e., more frequent or severe impacts of Parkinson's disease on daily functioning and well-being).
Time frame: At baseline (Week 0)
Plan to share: No
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