Skip to main content
OpenTrials
Completed

NCT Number: NCT05762562

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ics Maugeri

Pavia, PV, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Patient's satisfaction

    Time frame: 1 year

    Administration of a specific questionnaire to evaluate the patient's satisfaction with TR treatment program with free open-source platforms

  2. Patient's agreement

    Time frame: 1 year

    Administration of a specific questionnaire to evaluate the patient's agreement with TR treatment program with free open-source systems

  3. Maintenance of clinical outcomes - Walking speed

    Time frame: 1 year

    Walking speed using 10 Meter Walking Test (10 MWT) rated in seconds. Comparison between T0 and T1 in the groups A and B. A descriptive analysis of the results was then conducted.

  4. Maintenance of clinical outcomes - Balance

    Time frame: 1 year

    Balance using MiniBEST Test (values: 0 minimum - 28 maximum). Comparison between T0 and T1 in the groups A and B. A descriptive analysis of the results was then conducted.

  5. Maintenance of clinical outcomes - Risk of falling

    Time frame: 1 year

    Risk of falling using the Time Up and Go (TUG Test) rated in seconds. Comparison between T0 and T1 in the groups A and B. A descriptive analysis of the results was then conducted.

  6. Perceived level of quality of life

    Time frame: 1 years

    Evaluation of the level of perceived quality of life using the the Parkinson's Disease Questionnaire (short version)(PDQ-8), (values: 0 minimum - 32 maximum. The summed scor is then divided by total possible score an given as a percentage score out of 100). Comparison between T0 and T1 in the groups A and B.

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.