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

March 12, 2024 updated by: Wizecare

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleavelnad Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: In clinic physical therapy
Patients visit the clinic to receive traditional physical therapy treatment
Other: Telerehabilitation only
Patients receive remote treatment using the Wizecare platform
Other Names:
  • Wizecare Telerehabilitation Platform
Experimental: 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.
Other: Telerehabilitation only
Patients receive remote treatment using the Wizecare platform
Other Names:
  • Wizecare Telerehabilitation Platform
Active Comparator: Control group
Patients received treatment in the clinic in the presence of their PT
Other: In clinic physical therapy
Patients visit the clinic to receive traditional physical therapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to end of treatment at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effectiveness of TR
Time Frame: From enrollment to end of treatment at 5 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wizecare

Investigators

  • Principal Investigator: Mary Stilphen, PT, DPT, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

January 23, 2023

Study Completion (Actual)

January 23, 2023

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00005367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: 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 bella@wizecare.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on In clinic physical therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe