Remote Haptic Rehabilitation for Parkinson's Disease

Official title

Enhancing Parkinson's Disease Rehabilitation Through Remote Haptic Guidance: Field Study

Overview

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.

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.

Interventions

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

Primary outcome measures

• System Usability Scale (SUS) [Time frame: At the end of the trial in week 8]
• Arm movement accuracy, speed, and smoothness [Time frame: From enrollment to the end of intervention at 8 weeks]

Secondary outcome measures (3)

• Outcome Expectations of Exercise Scale (OEES) [Time frame: At the end of the trial in week 8]
• Self-Efficacy Scale (SES) [Time frame: At the end of the trial in week 8]
• Parkinson's Disease Questionnaire (PDQ-8) [Time frame: At baseline (Week 0)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Virginia Tech — Blacksburg

Publications

• Garzo, A., Jung, J. H., Arcas-Ruiz-Ruano, J., Perry, J. C., & Keller, T. (2022). ArmAssist: A telerehabilitation solution for upper-limb rehabilitation at home. IEEE Robotics & Automation Magazine, 30(1), 62-71.
• Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2. PMID 28000926
• Langer A, Gassner L, Flotz A, Hasenauer S, Gruber J, Wizany L, Pokan R, Maetzler W, Zach H. How COVID-19 will boost remote exercise-based treatment in Parkinson's disease: a narrative review. NPJ Parkinsons Dis. 2021 Mar 8;7(1):25. doi: 10.1038/s41531-021-00160-3. PMID 33686074
• Zaman MS, Ghahari S, McColl MA. Barriers to Accessing Healthcare Services for People with Parkinson's Disease: A Scoping Review. J Parkinsons Dis. 2021;11(4):1537-1553. doi: 10.3233/JPD-212735. PMID 34308913
• Xia R, Mao ZH. Progression of motor symptoms in Parkinson's disease. Neurosci Bull. 2012 Feb;28(1):39-48. doi: 10.1007/s12264-012-1050-z. PMID 22233888
• Marras C, Beck JC, Bower JH, Roberts E, Ritz B, Ross GW, Abbott RD, Savica R, Van Den Eeden SK, Willis AW, Tanner CM; Parkinson's Foundation P4 Group. Prevalence of Parkinson's disease across North America. NPJ Parkinsons Dis. 2018 Jul 10;4:21. doi: 10.1038/s41531-018-0058-0. eCollection 2018. PMID 30003140
• GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1. PMID 30287051
• Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1. PMID 28150045

Identifiers

NCT: NCT07457710 · 25-839 · 208-05-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗