Telerehabilitation for Parkinson's Disease

NCT04600011 | Completed

• 1 other identifier: 19050804-IRB01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Adherence Measure - 1:

  (1) The proportion of scheduled protocol-driven tele-PT and tele-OT visits that were completed.

  Through study completion of approximately 18 months.

• Adherence Measure - 2:

  (2) The proportion of scheduled protocol-driven PT/OT exercises/activities that could be completed virtually as assessed by the instructing study therapist.

  Through study completion of approximately 18 months.

• Adherence Measure - 3:

  (3) Qualitative categorization of limitations in performing tele-PT and tele-OT visits and PT/OT exercises/activities virtually into patient-related, technology-related, or environmentally-related limitations

  Through study completion of approximately 18 months.

• Retention Measures:

  The proportion of patient and care partner (P+CP) pairs that enrolled and were able to complete the study, i.e. study drop-out rate.

  Through study completion of approximately 18 months.

• Safety Measures:

  The number and nature of adverse and serious adverse events that occurred due to participation in the study, and the proportion deemed a result of study-related interventions.

  Through study completion of approximately 18 months.

Secondary Outcomes (13)

• Goals Attainment Scale Score:

  Through study completion of approximately 18 months.

• Falls Diary;

  Through study completion of approximately 18 months.

• Activities-Specific Balance Scale:

  Through study completion of approximately 18 months.

• Five-Times Sit-to-Stand Test:

  Through study completion of approximately 18 months.

• In-Person Objective Therapy Measure - 1:

  Through study completion of approximately 18 months.

Other Outcomes (2)

• APDM Mobility Lab Sensor Data:

  Through study completion of approximately 18 months.

• "Telehealth Satisfaction Survey":

  Through study completion of approximately 18 months.

Study Arms (2)

TELEREHABILITATION ARM

OTHER

ARM 1: The TELEREHABILITATION ARM where participants receive the full originally-intended protocol that includes one initial in-person PT/OT evaluation, four virtual PT/OT visits, and one final in-person (or virtual, if in-person is not possible) PT/OT evaluation. The study duration for Arm 1 is about 10 weeks of the primary intervention as described with 3- and 6-month follow-up calls. The mobile virtual platform for Arm 1 is comprised of a tablet on a height-adjustable rotating tablet floor stand with a gooseneck and wheels.

Other: Physical and occupational therapy (PT/OT)

VIRTUAL HOME SAFETY EVALUATIONS (HSE)-ONLY ARM

OTHER

ARM 2: 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.

Other: Home Safety Evaluation (HSE)

Interventions

Physical and occupational therapy (PT/OT) OTHER

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.

TELEREHABILITATION ARM

Home Safety Evaluation (HSE) OTHER

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.

VIRTUAL HOME SAFETY EVALUATIONS (HSE)-ONLY ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject's age is greater than or equal to 18.
• Subject has a diagnosis of Idiopathic Parkinson's Disease according to established criteria and this has been confirmed by a Movement Disorders Neurologist.
• Subject's Movement Disorders Neurologist believes he/she would benefit from specialized physical and occupational therapy to reduce fall risk.
• Subject's Idiopathic Parkinson's Disease is Hoehn and Yahr stage 2 or 3 in the "OFF"-medication state (stage 2 defined by bilateral or midline symptoms with less than or equal to 2 steps back on the pull test with self-recovery; stage 3 is defined by more than 2 steps back on the pull test with or without self-recovery, or no steps back and requiring assistance to recover).
• Subject demonstrates the ability to utilize the virtual platform at their initial in-person evaluation.
• Subject has been on a stable medication regimen for the treatment of Idiopathic Parkinson's Disease for the month preceding the baseline in-person visit, and has the ability to maintain stable dosing for the duration of the 10-week primary intervention.
• Subject has home Wi-Fi access for the tele-neurorehabilitation home visits and a personal tablet with Wi-Fi connectivity.
• Care partner's age is greater than or equal to 18.
• Care partner has been the primary caregiver for \>6 months and will remain so for at least 10 weeks to the study subject.
• Care partner has the ability and desire to participate in all of the study visits with the study subject, including the tele-neurorehabilitation home visits.
• Care partner has the ability and desire to provide stand-by assistance, but in the setting of a gait belt, to the study subject during tele-neurorehabilitation home visits.

You may not qualify if:

• Subject is non-English speaking.
• Subject has only a provisional diagnosis of Idiopathic Parkinson's Disease or atypical features suggestive of an alternative diagnosis.
• Subject has and additional significant neurologic diagnosis that may render him/her with neurologic deficits that may affect gait and balance.
• Subject has another destabilizing chronic medical condition which may warrant frequent hospitalization or render the patient unable to participate in physical activity.
• Subject requires more than just stand-by assistance for gait and balance.
• Subject is reliant on mobility devices to walk (walkers, cane, walking sticks, motorized scooter, etc).
• Subject is receiving physical therapy elsewhere during the month preceding the study and during the duration of the study.
• Subject has no care partner available to participate in all of the study visits.
• Subject is unable to follow direction or consent to research.
• Subject is unable to commit to the study-related activities and/or schedule of events.
• Care partner is non-English speaking.
• Care partner is unable to follow direction or consent to research.
• Care partner is unable to commit to the study-related activities and/or schedule of events.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (8)

• 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 BACKGROUND

• Macht M, Kaussner Y, Moller JC, Stiasny-Kolster K, Eggert KM, Kruger HP, Ellgring H. Predictors of freezing in Parkinson's disease: a survey of 6,620 patients. Mov Disord. 2007 May 15;22(7):953-6. doi: 10.1002/mds.21458.

  PMID: 17377927 BACKGROUND

• Hely MA, Morris JG, Reid WG, Trafficante R. Sydney Multicenter Study of Parkinson's disease: non-L-dopa-responsive problems dominate at 15 years. Mov Disord. 2005 Feb;20(2):190-9. doi: 10.1002/mds.20324.

  PMID: 15551331 BACKGROUND

• Poewe W. The natural history of Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII2-6. doi: 10.1007/s00415-006-7002-7.

  PMID: 17131223 BACKGROUND

• Low V, Ben-Shlomo Y, Coward E, Fletcher S, Walker R, Clarke CE. Measuring the burden and mortality of hospitalisation 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. doi: 10.1016/j.parkreldis.2015.01.017. Epub 2015 Feb 17.

  PMID: 25737205 BACKGROUND

• Wielinski CL, Erickson-Davis C, Wichmann R, Walde-Douglas M, Parashos SA. Falls and injuries resulting from falls among patients with Parkinson's disease and other parkinsonian syndromes. Mov Disord. 2005 Apr;20(4):410-415. doi: 10.1002/mds.20347.

  PMID: 15580552 BACKGROUND

• Pressley JC, Louis ED, Tang MX, Cote L, Cohen PD, Glied S, Mayeux R. The impact of comorbid disease and injuries on resource use and expenditures in parkinsonism. Neurology. 2003 Jan 14;60(1):87-93. doi: 10.1212/wnl.60.1.87.

  PMID: 12525724 BACKGROUND

• Afshari M, Hernandez AV, Joyce JM, Hauptschein AW, Trenkle KL, Stebbins GT, Goetz CG. A Novel Home-Based Telerehabilitation Program Targeting Fall Prevention in Parkinson Disease: A Preliminary Trial. Neurol Clin Pract. 2024 Feb;14(1):e200246. doi: 10.1212/CPJ.0000000000200246. Epub 2024 Jan 5.

  PMID: 38213401 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Restraint, Physical; Occupational Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Mitra Afshari, MD, MPH

  Rush University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Sciences

Model Details: Pilot feasibility study, non-controlled

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: October 23, 2020
• Study Start: January 21, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)