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Clinical Trials/NCT06246747
NCT06246747CompletedNot Applicable

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

Wizecare2 sites in 1 country19 target enrollmentStarted: February 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
19
Locations
2
Primary Endpoint
Satisfaction assessment

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Satisfaction assessment

Time Frame: From enrollment to end of treatment at 5 weeks

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.

Secondary Outcomes

  • Clinical effectiveness of TR(From enrollment to end of treatment at 5 weeks)

Investigators

Sponsor
Wizecare
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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