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Clinical Trials/NCT05762562
NCT05762562
Completed
Not Applicable

Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program for Parkinson's Disease With Open-source Platforms. A Pilot Study.

Istituti Clinici Scientifici Maugeri SpA1 site in 1 country33 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Enrollment
33
Locations
1
Primary Endpoint
The opportunity of the usage TR in PD patients by using free open-source platforms
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Participants were PD patient afferent to the Neurology ambulatory. Patients underwent an initial evaluation (T0) by the neurologist and physiotherapist. During T0, also the level of digital literacy was evaluated Participants included in the study were separated into three groups based on their residual motor skills evaluated by the Short Physical Performance Battery (SPPB). Each group corresponded to a Program (Pr). SPPB score between 12 and 10: Pr. A for patients with capable motor skills; they were were associated to the TR program A (TrP.A). SPPB score between 9 and 7: Pr. B for patients with reduced motor skills; they were were associated to the TR program B (TrP.B). SPPB score lower than 7: Pr. C for patients who didn't show having sufficient motor skills; they were were associated to the telemonitoring program C (TmP.C) without any exercise program. Patients who were included in TrP.A and TrP.B underwent a TR program using OS platforms for 8 consecutive weeks. OS platforms used are: Zoom, Skype, Google Teams, WhatsApp. The patient was given the opportunity to choose the operating system to use based on their knowledge, computer skills and ease of use to facilitate the management of the session. Patients in TrP.A and TrP.B had to perform at home a tailored exercise program 4 times/week for 45-60 minutes. Twice a week, the activity was performed with physiotherapist through OSp. 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. Both programs, A and B, include multiple exercise: aerobic activities, mobility and stretching exercises for upper and lower limbs, global muscle strengthening, balance \& motor coordination training, start and stop exercises and walking training. The exercises in program A were more complex and showed a higher intensity, while those in program B were simpler, safer and at lower intensity. 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. 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chiara Vellata

Physiotherapy

Istituti Clinici Scientifici Maugeri SpA

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 1 year

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

Secondary Outcomes

  • Patient's agreement(1 year)
  • Patient's satisfaction(1 year)
  • Maintenance of clinical outcomes - Walking speed(1 year)
  • Maintenance of clinical outcomes - Risk of falling(1 year)
  • Maintenance of clinical outcomes - Balance(1 year)
  • Perceived level of quality of life(1 years)

Study Sites (1)

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