Telerehabilitation for Parkinson's Disease

NCT04600011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-09-16

No results posted yet for this study

Summary

Our primary objective in this 10-week pilot study is to demonstrate the feasibility of using videoconferencing technology to provide Parkinson's Disease (PD) patients, alongside their supervising care partners, specialized physical and occupational therapy (PT/OT) focused on neurorehabilitation that ultimately aims to reduce fall risk. This therapy is similar to what a PD patient could receive in-person with neurologic-certified physical therapists and occupational therapists with significant experience working with PD patients and addressing their needs, but it is delivered through a virtual platform. Feasibility is defined by measures of adherence, retention, and safety.

The specialized PT and OT measurement tools and strategies used in this study are in-line with the most current formal evidence-based guidelines/recommendations available for therapy in PD: European Physiotherapy Guideline for Parkinson's Disease, Parkinson Evidence Database to Guide Effectiveness (PD-EDGE) Task Force and Guidelines for Occupational Therapy in Parkinson's Disease Rehabilitation.

The study duration is approximately 10 weeks of the primary telerehabilitation intervention and a 2 follow-up phone calls at the 3- and 6-month timepoints. There will be one baseline in-person evaluation and one final in-person evaluation following the completion of all televisits. The enrollment target is up to 15-20 patient and care partner (P+CP) pairs, meaning 30-40 subjects total. There are no controls for this study.

Conditions

  • Parkinson Disease
  • Telemedicine

Interventions

OTHER

Physical and occupational therapy (PT/OT)

Neurologic-specialized and -certified physical and occupational therapists will provide each participant with an initial in-person PT/OT evaluation/treatment session with oversight from a Movement Disorders Neurologist, followed by 4 "virtual home visits" with tele-PT/OT and care partner supervision every 2 weeks, and culminating with a final in-person evaluation, all with a focus on personalized training in core areas contributing to a patient's individual fall risk, much like in-person visits. Virtual home safety surveillance with the mobile virtual platform is an additional feature of this intervention that aims to optimize the home environment to reduce external factors contributing to fall risk.

OTHER

Home Safety Evaluation (HSE)

The VIRTUAL HOME SAFETY EVALUTIONS (HSE)-ONLY ARM where participants ONLY receive the virtual home safety evaluations and surveillance that are built into the original protocol of three of the four tele-OT visits that is being used in Arm 1. The study duration for Arm 2 is about 6 weeks of the primary intervention as described with 3-month and 6-month follow-up calls. The mobile virtual platform for Arm 2 is comprised of a tablet OR smartphone that will be guided through the home by the care partner only and not the patient.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Mitra Afshari, MD, MPH · Rush University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2021-06-15
Completion
2021-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04600011 on ClinicalTrials.gov