Clinical trial NCT05762562: Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program. A Pilot Study.
Official title: Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program for Parkinson's Disease With Open-source Platforms. A Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Telerehabilitation
Remote Physical Activity
Rehabilitation
Digital Health
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease patients with different residual motor skills.

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.

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.

Primary outcomes:
measure: The opportunity of the usage TR in PD patients by using free open-source platforms
timeFrame: 1 year
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: 1 year
measure: Patient's agreement
timeFrame: 1 year
measure: Maintenance of clinical outcomes - Walking speed
timeFrame: 1 year
measure: Maintenance of clinical outcomes - Balance
timeFrame: 1 year
measure: Maintenance of clinical outcomes - Risk of falling
timeFrame: 1 year
measure: Perceived level of quality of life
timeFrame: 1 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Ics Maugeri
state: PV
Study officials:
References: