Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Parkinson Disease
  • Telemedicine
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Pilot feasibility study, non-controlledMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Gait dysfunction, postural instability, and freezing-of-gait (FOG) ultimately develop in about 80% of PD patients, which lead to falls and advancing disability. This is significant because the consequences of falls are far-reaching: accelerating immobility due to heightened fear-of-falling, reducing...

Gait dysfunction, postural instability, and freezing-of-gait (FOG) ultimately develop in about 80% of PD patients, which lead to falls and advancing disability. This is significant because the consequences of falls are far-reaching: accelerating immobility due to heightened fear-of-falling, reducing quality of life and independence, and increasing healthcare utilization and costs. Thus, there is an urgent need to expand evidence- based outpatient neurologic-PT/OT services to community-dwelling PD patients to reduce fall risk. This research proposal will address this unmet need by determining whether tele-neurorehabilitation is a care model that can be executed safety for PD patients to provide these services from well-trained therapists who are not easily accessible otherwise. This feasibility data is critical in the development of a novel tele-neurorehabilitation protocol and randomized-controlled efficacy trial thereafter. The impact of the intended research is to demonstrate the feasibility and preliminary efficacy of this novel teleconferencing-based delivery of gait and balance exercises/strategies with guided instruction much like one would receive in-person but in the comfort of one's own home. By demonstrating the feasibility and preliminary efficacy of this pilot program, subsequent long-term goals are to apply for larger sources of funding to sustain the program. By leveraging the data gained from these studies it is anticipated the practice of telerehabilitation will be expanded and improved; and ultimately its efficacy to health care policy providers and insurers for potential reimbursement will be demonstrated. The researchers intend to enroll 15-20 individuals with mild-moderate PD into our proposed novel telerehabilitation program, where patients will receive tele-PT/OT home visits and home-safety surveillance with neurologic-specialized therapists who are experienced with the core problem areas seen in PD patients. The intended clinical impact is to improve gait/balance function and postural stability, and thus reduce falls in patients with PD. With the remote telecommunications intervention, we aim to enable the additional clinical impact of expanding access to therapy for people with PD that otherwise would have significant difficulty obtaining this type of multiple-visit, individually-tailored, and specialized therapy care due to travel burden and cost. References: Marras C, Beck JC, Bower JH, et al. Prevalence of Parkinson's disease across North America. NPJ Parkinsons Dis. 2018 Jul 10;4:21. Macht M, Kaussner Y, Moeller JC, et al. Predictors of freezing in Parkinson's disease: a survey of 6,620 patients. Mov Disord. 2007; 22:953-956. Hely MA, Morris JG, Reid WG, et al. Sydney Multicenter Study of Parkinson's disease: non-L-dopa-responsive problems dominate at 15 years. Mov Disord. 2005; 20:190-199. Poewe W. The natural history of Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII2-6. Low V, Ben-Shlomo Y, Coward E, et al. Measuring the burden and mortality of hospitalization in Parkinson's disease: A cross-sectional analysis of the English Hospital Episodes Statistics database 2009-2013. Parkinsonism Relat Disord. 2015 May;21(5):449-54. Wielinski Cl, Erickson-Davis C, Wichmann R, et al. Falls and injuries resulting from falls among patients with Parkinson's disease and other Parkinsonian syndromes. Mov Disord. 2005;20:410-415. Pressley JC, Louis ED, Tang MX, et al. The impact of comorbid disease and injuries on resource use and expenditures in parkinsonism. Neurology. 2003 Jan 14;60(1):87-93.

Tracking Information

NCT #
NCT04600011
Collaborators
Not Provided
Investigators
Principal Investigator: Mitra Afshari, MD, MPH Rush University