Clinical trial NCT04600011: Telerehabilitation for Parkinson's Disease
Official title: A Novel Tele-Neurorehabilitation Program Aimed at Reducing Fall Risk in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Telemedicine
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot feasibility study, non-controlled
Primary purpose: TREATMENT

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.

Detailed 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 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.

Eligibility criteria: Subject Inclusion Criteria:

1. Subject's age is greater than or equal to 18.
2. Subject has a diagnosis of Idiopathic Parkinson's Disease according to established criteria and this has been confirmed by a Movement Disorders Neurologist.
3. Subject's Movement Disorders Neurologist believes he/she would benefit from specialized physical and occupational therapy to reduce fall risk.
4. 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).
5. Subject demonstrates the ability to utilize the virtual platform at their initial in-person evaluation.
6. 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.
7. Subject has home Wi-Fi access for the tele-neurorehabilitation home visits and a personal tablet with Wi-Fi connectivity.

Care Partner Inclusion Criteria:

1. Care partner's age is greater than or equal to 18.
2. Care partner has been the primary caregiver for \>6 months and will remain so for at least 10 weeks to the study subject.
3. 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.
4. 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.

Subject Exclusion Criteria:

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

Care Partner Exclusion Criteria:

1. Care partner is non-English speaking.
2. Care partner is unable to follow direction or consent to research.
3. Care partner is unable to commit to the study-related activities and/or schedule of events.

Primary outcomes:
measure: Adherence Measure - 1:
timeFrame: Through study completion of approximately 18 months.
measure: Adherence Measure - 2:
timeFrame: Through study completion of approximately 18 months.
measure: Adherence Measure - 3:
timeFrame: Through study completion of approximately 18 months.
measure: Retention Measures:
timeFrame: Through study completion of approximately 18 months.
measure: Safety Measures:
timeFrame: Through study completion of approximately 18 months.
Secondary outcomes:
measure: Goals Attainment Scale Score:
timeFrame: Through study completion of approximately 18 months.
measure: Falls Diary;
timeFrame: Through study completion of approximately 18 months.
measure: Activities-Specific Balance Scale:
timeFrame: Through study completion of approximately 18 months.
measure: Five-Times Sit-to-Stand Test:
timeFrame: Through study completion of approximately 18 months.
measure: In-Person Objective Therapy Measure - 1:
timeFrame: Through study completion of approximately 18 months.
measure: In-Person Objective Therapy Measure - 2:
timeFrame: Through study completion of approximately 18 months.
measure: In-Person Objective Therapy Measure - 3:
timeFrame: Through study completion of approximately 18 months.
measure: In-Person Objective Therapy Measures - 4:
timeFrame: Through study completion of approximately 18 months.
measure: In-Person Objective Therapy Measure - 5:
timeFrame: Through study completion of approximately 18 months.
measure: In-Person Objective Therapy Measures - 6:
timeFrame: Through study completion of approximately 18 months.
measure: Rapid Turns Test:
timeFrame: Through study completion of approximately 18 months.
measure: Parkinson's Disease Questionnaire-39:
timeFrame: Through study completion of approximately 18 months.
measure: Home Exercise Program:
timeFrame: Through study completion of approximately 18 months.
Other outcomes:
measure: APDM Mobility Lab Sensor Data:
timeFrame: Through study completion of approximately 18 months.
measure: "Telehealth Satisfaction Survey":
timeFrame: Through study completion of approximately 18 months.
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University
name: Mitra Afshari, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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