The Use of Telerehabilitation to Improve Movement Outcomes for Patients With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

The Use of Telerehabilitation to Improve Movement-related Outcomes and Quality of Life for Patients With Parkinson's Disease: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06246747
• Other study ID #: 00005367
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 23, 2023

Study information

• Verified date: December 2023
• Source: Wizecare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient older than 18 with PD of any duration
• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• In clinic physical therapy
Patients visit the clinic to receive traditional physical therapy treatment
• Telerehabilitation only
Patients receive remote treatment using the Wizecare platform

Locations

Country	Name	City	State
United States	Cleavelnad Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wizecare

Country where clinical trial is conducted

United States, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction assessment	We assessed satisfaction with the mode of care delivery using novel surveys, which were administered to the patient and the physical therapist at the in-clinic discharge visit via the Research Electronic Data Captureapture (REDCap) platform. Each survey assessed eight constructs; six satisfaction items were rated on a 5-point Likert scale ("very poor", "poor", "fair", "good", or "very good"). The number 1 stood for "very poor" and the number 5 stood for "very good". The item pertaining to safety asked for a 0 ("very unsafe") to 100 ("very safe") rating.	From enrollment to end of treatment at 5 weeks
Secondary	Clinical effectiveness of TR	Clinical effectiveness was measured by the Parkinson's Disease Questionnaire (PDQ-39) which is a self-reported questionnaire. It consists of 39 items across eight domains: Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort. Each item is rated on a scale from 0 to 4, with 0 representing no difficulty and 4 representing severe difficulty. Scores are calculated by summing the responses for each domain and transforming them into a score ranging from 0 to 100, with higher scores indicating worse quality of life.	From enrollment to end of treatment at 5 weeks