The Use of Telerehabilitation to Improve Movement Outcomes for Patients With Parkinson Disease
NCT ID: NCT06246747
Last Updated: 2024-03-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
19 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-02-01
Study Completion Date
2023-01-23
Brief Summary
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The goal of this pilot randomized clinical trial was to assess the feasibility of telerehabilitation (TR) for patients with Parkinson\'s Disease (PD). The main questions it aims to answer are: 1. whether the recruitment to such a study will be successful and the satisfaction of both participants and clinicians will be good. 2. Clinical effectiveness of TR for patients with PD was also explored. Participants were randomized to 3 groups : 1. Clinic+TR. 2. TR-only group and 3. A usual control group. Results were compared between the groups.
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Detailed Description
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Patients were identified for pre-screening if they had a diagnosis of PD for any duration and were scheduled for a new episode of physical therapy. Pre-screening included chart review by a study coordinator. The exclusion criteria were: any outpatient physical therapy episode in the preceding 5 months, documented diagnosis of another progressive neurological disease, history of epilepsy, moderate to severe cognitive impairment, hemiparesis or hemiplegia, current complaints of dizziness. Though not an a priori criterion, some patients could not be scheduled for study participation due to a lack of availability on the schedules of participating therapists.
Those meeting eligibility criteria were contacted in writing (via mailed letter or electronic health record portal) then via phone by a coordinator two to four weeks prior to their initial physical therapy visit. At pre-screen phone call, patients were excluded if they were not reached, reported not having a reliable caregiver or internet connection in their home, or declined to participate.
After chart review and phone screening, those interested in participation were consented in-person by the study coordinator and further screened for eligibility by the evaluating physical therapist immediately prior to their initial physical therapy visit. Final eligibility was determined by completion of the timed-up-and-go test (TUG) less than15 seconds, a 10-meter gait speed of more than 0.8 m/s, and a subjective determination of safety by the evaluating physical therapist.
The primary intervention of interest in this study was the delivery of physical therapist interventions using a TR platform (WizeCare Technologies, Or Yehuda, Israel). Patients completed TR on a tablet (Lenovo Yoga Tab 3, Model YT3-X50F, OS Android 6.0) provided by WizeCare, their own tablet, their own laptop or desktop computer, or their own cell phone. If by tablet or cell phone, the platform was accessed using a mobile app. If by computer, the platform was accessed via the internet.
The WizeCare TR platform enables remote rehabilitation training and monitoring using a customized combination of video conferencing and libraries of pre-recorded videos of specific exercises. These videos can be combined manually to create unique exercise plans for patients that vary in content and duration. Immediately prior to this study, a series of videos of common PD-specific exercises were produced and stored in a specific library on the platform. Physical therapists built customized home exercise programs primarily from this library, though videos from any library were available for use. The platform also features an option for live video calls between patients and therapists, which enabled ongoing communication and re-evaluation for manual adjustment of the rehabilitation plan as needed.
Baseline demographic variables were age and gender. Baseline clinical variables were years since PD diagnosis, the modified Hoehn and Yahr scale, and the Unified Parkinson's Disease Rating Scale (UPDRS). Hoehn and Yahr stages range from 1 (unilateral involvement only) to 5 (wheelchair-bound or bedridden unless aided), with the modified scale including stages 1.5 and 2.5 to account for intermediate phases of disease progression. The UPDRS is a clinician-rated instrument of observable PD symptoms that are assessed for four different constructs: mental dysfunction and mood, activities of daily living, motor function, and treatment-related complications; higher UPDRS total scores indicate greater symptom severity.
At each interaction with the treating physical therapist-in clinic or via the TR platform-subjective feedback was provided verbally by the patient regarding the safety of the exercises he or she completed at home. This is consistent with current standard practice. Any reported fall or other adverse event, whether in conjunction with the exercise program or otherwise, was reviewed by the study team (the four treating physical therapists and the PI). These were recorded and reported to the Institutional Review Board as required.
Additionally, the WizeCare platform enables a safety assessment with each session in which a patient interacts with the system, including their unsupervised home exercise sessions. At the conclusion of each session on the platform, patients are asked, "Did the patient feel safe during this session?" If they answer "No", the system can send an automated message to the treating physical therapist. The system also provides an automated response to the patient to, "Please stop participating in the exercise program and call the treating physical therapist." Initiated by either the physical therapist or the patient within 24 hours of the reported lack of safety, a conversation between them will allow the patient to express their safety concerns. Any such events were recorded as adverse events, with subsequent steps as outlined above. These patient self-reports of safety were included amongst exploratory outcomes.
Those meeting eligibility criteria were contacted in writing (via mailed letter or electronic health record portal) then via phone by a coordinator two to four weeks prior to their initial physical therapy visit. At pre-screen phone call, patients were excluded if they were not reached, reported not having a reliable caregiver or internet connection in their home, or declined to participate.
After chart review and phone screening, those interested in participation were consented in-person by the study coordinator and further screened for eligibility by the evaluating physical therapist immediately prior to their initial physical therapy visit. Final eligibility was determined by completion of the timed-up-and-go test (TUG) less than15 seconds, a 10-meter gait speed of more than 0.8 m/s, and a subjective determination of safety by the evaluating physical therapist.
The primary intervention of interest in this study was the delivery of physical therapist interventions using a TR platform (WizeCare Technologies, Or Yehuda, Israel). Patients completed TR on a tablet (Lenovo Yoga Tab 3, Model YT3-X50F, OS Android 6.0) provided by WizeCare, their own tablet, their own laptop or desktop computer, or their own cell phone. If by tablet or cell phone, the platform was accessed using a mobile app. If by computer, the platform was accessed via the internet.
The WizeCare TR platform enables remote rehabilitation training and monitoring using a customized combination of video conferencing and libraries of pre-recorded videos of specific exercises. These videos can be combined manually to create unique exercise plans for patients that vary in content and duration. Immediately prior to this study, a series of videos of common PD-specific exercises were produced and stored in a specific library on the platform. Physical therapists built customized home exercise programs primarily from this library, though videos from any library were available for use. The platform also features an option for live video calls between patients and therapists, which enabled ongoing communication and re-evaluation for manual adjustment of the rehabilitation plan as needed.
Baseline demographic variables were age and gender. Baseline clinical variables were years since PD diagnosis, the modified Hoehn and Yahr scale, and the Unified Parkinson's Disease Rating Scale (UPDRS). Hoehn and Yahr stages range from 1 (unilateral involvement only) to 5 (wheelchair-bound or bedridden unless aided), with the modified scale including stages 1.5 and 2.5 to account for intermediate phases of disease progression. The UPDRS is a clinician-rated instrument of observable PD symptoms that are assessed for four different constructs: mental dysfunction and mood, activities of daily living, motor function, and treatment-related complications; higher UPDRS total scores indicate greater symptom severity.
At each interaction with the treating physical therapist-in clinic or via the TR platform-subjective feedback was provided verbally by the patient regarding the safety of the exercises he or she completed at home. This is consistent with current standard practice. Any reported fall or other adverse event, whether in conjunction with the exercise program or otherwise, was reviewed by the study team (the four treating physical therapists and the PI). These were recorded and reported to the Institutional Review Board as required.
Additionally, the WizeCare platform enables a safety assessment with each session in which a patient interacts with the system, including their unsupervised home exercise sessions. At the conclusion of each session on the platform, patients are asked, "Did the patient feel safe during this session?" If they answer "No", the system can send an automated message to the treating physical therapist. The system also provides an automated response to the patient to, "Please stop participating in the exercise program and call the treating physical therapist." Initiated by either the physical therapist or the patient within 24 hours of the reported lack of safety, a conversation between them will allow the patient to express their safety concerns. Any such events were recorded as adverse events, with subsequent steps as outlined above. These patient self-reports of safety were included amongst exploratory outcomes.
Conditions
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Parkinson Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Physical therapy treatment in the clinic + telerehabilitation
Patients performed treatments in the clinic in the presence of their physical therapist (PT) as well as perform remote treatment from their homes. The remote treatment included using video chat with their PT as well as performing PD-specific exercises which were stored in a specific library on the platform.
Group Type
EXPERIMENTAL
In clinic physical therapy
Intervention Type
OTHER
Patients visit the clinic to receive traditional physical therapy treatment
Telerehabilitation only
Intervention Type
OTHER
Patients receive remote treatment using the Wizecare platform
TR-only
Patients received treatment at their homes using the TR platform. This included video chat with their clinician as well as performing PD-specific exercises which were stored in a specific library on the platform.
Group Type
EXPERIMENTAL
Telerehabilitation only
Intervention Type
OTHER
Patients receive remote treatment using the Wizecare platform
Control group
Patients received treatment in the clinic in the presence of their PT
Group Type
ACTIVE_COMPARATOR
In clinic physical therapy
Intervention Type
OTHER
Patients visit the clinic to receive traditional physical therapy treatment
Interventions
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In clinic physical therapy
Patients visit the clinic to receive traditional physical therapy treatment
Intervention Type
OTHER
Telerehabilitation only
Patients receive remote treatment using the Wizecare platform
Intervention Type
OTHER
Other Intervention Names
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Wizecare Telerehabilitation Platform
Eligibility Criteria
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Inclusion Criteria
* Patient older than 18 with PD of any duration
* The patient was scheduled for a new episode of physical therapy.
* The patient was scheduled for a new episode of physical therapy.
Exclusion Criteria
* Any outpatient physical therapy episode in the preceding 5 months
* Documented diagnosis of another progressive neurological disease
* History of epilepsy
* Moderate to severe cognitive impairment
* Hemiparesis or hemiplegia
* Current complaints of dizziness
* Documented diagnosis of another progressive neurological disease
* History of epilepsy
* Moderate to severe cognitive impairment
* Hemiparesis or hemiplegia
* Current complaints of dizziness
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Wizecare
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mary Stilphen, PT, DPT
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleavelnad Clinic
Cleveland, Ohio, United States
Site Status
Countries
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United States
References
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Cornforth E. Telerehabilitation Has Potential, But More Research, Funding, And Advocacy Are Needed. Health Affairs Forefront. Published online January 5, 2023
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Chatto CA, York PT, Slade CP, Hasson SM. Use of a Telehealth System to Enhance a Home Exercise Program for a Person With Parkinson Disease: A Case Report. J Neurol Phys Ther. 2018 Jan;42(1):22-29. doi: 10.1097/NPT.0000000000000209.
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Johnson JK, Longhurst JK, Gevertzman M, Jefferson C, Linder SM, Bethoux F, Stilphen M. The Use of Telerehabilitation to Improve Movement-Related Outcomes and Quality of Life for Individuals With Parkinson Disease: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Jul 31;8:e54599. doi: 10.2196/54599.
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DERIVED
Study Documents
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Document Type: Study Protocol
The protocol can be accessed by clicking the Google Drive link above. For any additional questions or an issue with opening the link, please contact [email protected]
View DocumentOther Identifiers
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00005367
Identifier Type: -
Identifier Source: org_study_id
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