Ics Maugeri
Pavia, PV, 27100, Italy
NCT Number: NCT05762562
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Observational
Pavia, PV, 27100, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: 1 year
Administration of a specific questionnaire to evaluate the patient's satisfaction with TR treatment program with free open-source platforms
Time frame: 1 year
Administration of a specific questionnaire to evaluate the patient's agreement with TR treatment program with free open-source systems
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.
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.
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.
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.
Istituti Clinici Scientifici Maugeri SpA
Other
Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program for Parkinson's Disease With Open-source Platforms. A Pilot Study.
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.
NCT06133283
Basal Ganglia Diseases, Brain Diseases
San Antonio, Texas, United States
View Trial DetailsNCT05766813
Basal Ganglia Diseases, Brain Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT07723027
Basal Ganglia Diseases, Brain Diseases
Shakargarh, Punjab Province, Pakistan
View Trial DetailsNCT07361250
Basal Ganglia Diseases, Brain Diseases
Wuhan, Hubei, China
View Trial Details