Remote Haptic Rehabilitation for Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Polytechnic Institute and State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years old

Diagnosed with PD

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Haptic device

    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.

  • Non-haptic device

    Device

    Participants will receive a handheld device similar to the haptic group. However, the device in this intervention will not provide any haptic feedback.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Haptic groupExperimental treatment 1 intervention
Group B: Non-haptic groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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)

Other outcomes

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