Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program. A Pilot Study.

NCT05762562 | Completed

• 1 other identifier: prot. 2486 CE, 06/10/2020
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) leads to multifactorial disabilities with consequent social restrictions, especially in the COVID-19 era. Continuity of care, especially rehabilitation measures, is critical to improve or maintain an adequate QoL for patients. The Parkinson Disease Telerehabilitation Program (PDTR) is an individualized home rehabilitation program using open-source platforms (OSp). The main purpose of this pilot study is to investigate the feasibility of TR in patients with PD by using free OS platforms (PDTR PROGRAM). The target of this study was to have at least 90% of participants completing the program. To complete the program every single patient had to complete at least 80% of the prescribed TR sessions.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Telerehabilitation; Remote Physical Activity; Rehabilitation; Digital Health

Outcome Measures

Primary Outcomes (1)

• The opportunity of the usage TR in PD patients by using free open-source platforms

  90% of participants completing the program. To complete the program every single patient had to complete at least 80% of the prescribed TR sessions

  1 year

Secondary Outcomes (6)

• Patient's satisfaction

  1 year

• Patient's agreement

  1 year

• Maintenance of clinical outcomes - Walking speed

  1 year

• Maintenance of clinical outcomes - Balance

  1 year

• Maintenance of clinical outcomes - Risk of falling

  1 year

Study Arms (1)

Telerehabilitation with OS platforms

Patients with Parkinson's Disease were divided into three subgruops based on their residual motor skills.

Other: Telerehabilitation with open source platforms

Interventions

Telerehabilitation with open source platforms OTHER

Telerehabilitation with opensource platforms. Patients enrolled were dived into three groups based on their score in SPPB. Each group corresponded to a Program (Pr): • Pr. A is for patients with capable motor skills, Pr. B is for patients with reduced motor skills, • Pr. C is for patients who didn't show having sufficient motor skills to support a TR program. Patients who were included in TrP.A and TrP.B underwent a TR program using OS platforms for 8 consecutive weeks. A specific exercise program for the parkinsonian patients was structured in relation to the individual residual motor skills based on the FITT - frequency/intensity/type/time - protocol. Twice a week, the activity was performed with the support of a physiotherapist through OS TR platform. Subjects included in TmP.C participated in an 8-weeks program. A video-call was scheduled once a week to monitor the patient's clinical condition without any exercise program.

Telerehabilitation with OS platforms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease patients with different residual motor skills.

You may qualify if:

• Hoehn \& Yahr (H\&Y) score between 1 and 3;
• being on drug treatment stabilized with L-Dopa or dopamine agonists;
• being able to walk independently (with or without help)
• having adequate computer knowledge, be able to use online communication platforms and to undertake a continuous 8-weeks program.

You may not qualify if:

• Montreal Cognitive Assessment screening test score below 17.54
• having unpredictable motor fluctuations or non-pharmacologically controlled dyskinesias
• having neurological pathologies superimposed on PD; or cognitive, sensory, psychiatric alterations such as to make it impossible to understand and execute the exercises; or musculoskeletal and cardiopulmonary diseases that compromise mild physical activity.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Ics Maugeri

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: March 9, 2023
• Study Start: February 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)