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

NCT ID: NCT05762562

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-02-28

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Telerehabilitation with OS platforms

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

Telerehabilitation with open source platforms

Intervention Type: 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.

Interventions

Telerehabilitation with open source platforms

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Chiara Vellata

Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ics Maugeri

Pavia, PV, Italy

Countries

Italy

Other Identifiers

prot. 2486 CE, 06/10/2020

Identifier Type: -

Identifier Source: org_study_id