Clinical Trials Directory

Trials / Completed

CompletedNCT05762562

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
33 (actual)
Sponsor
Istituti Clinici Scientifici Maugeri SpA · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERTelerehabilitation with open source platformsTelerehabilitation 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.

Timeline

Start date
2021-02-01
Primary completion
2022-02-28
Completion
2022-02-28
First posted
2023-03-09
Last updated
2023-03-09

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05762562. Inclusion in this directory is not an endorsement.