Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05762562 |
| Other study ID # |
prot. 2486 CE, 06/10/2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
February 28, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Istituti Clinici Scientifici Maugeri SpA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
