Parkinson DiseaseNCT05762562
Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program. A Pilot Study.
An observational study of Parkinson Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Telerehabilitation with open source platforms
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 28 Feb 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's disease patients with different residual motor skills.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program for Parkinson's Disease With Open-source Platforms. A Pilot Study.
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.
Read the 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
- Being tested
- Telerehabilitation with open source platforms
- Keywords
- Parkinson's Disease, Telerehabilitation, Remote Physical Activity, Rehabilitation, Digital Health
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation with open source platformsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation with OS platforms | Patients with Parkinson's Disease were divided into three subgruops based on their residual motor skills. Receives: Other: Telerehabilitation with open source platforms |
What is being measured
The primary outcome is the main question the study is designed to answer.
The opportunity of the usage TR in PD patients by using free open-source platforms
90% of participants completing the program. To complete the program every single patient had to complete at least 80% of the prescribed TR sessions
Measured: 1 year
Secondary outcomes (6)
Patient's satisfaction
Administration of a specific questionnaire to evaluate the patient's satisfaction with TR treatment program with free open-source platforms
Measured: 1 year
Patient's agreement
Administration of a specific questionnaire to evaluate the patient's agreement with TR treatment program with free open-source systems
Measured: 1 year
Maintenance of clinical outcomes - Walking speed
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.
Measured: 1 year
Maintenance of clinical outcomes - Balance
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.
Measured: 1 year
Maintenance of clinical outcomes - Risk of falling
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.
Measured: 1 year
Perceived level of quality of life
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.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Feb 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Vellata, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762562
- Sponsor's protocol ID
- prot. 2486 CE, 06/10/2020
- Status last verified
- Mar 2023
- First submitted
- 11 Jan 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson Disease Telerehabilitation Program (PDTR): a Home-motor Program for Parkinson's Disease With Open-source Platforms. A Pilot Study.
- ClinicalTrials.gov ID
- NCT05762562
- Acronym / sponsor ID
- prot. 2486 CE, 06/10/2020
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Telerehabilitation, Remote Physical Activity, Rehabilitation, Digital Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation with OS platforms | – | Other: Telerehabilitation with open source platformsPatients with Parkinson's Disease were divided into three subgruops based on their residual motor skills. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients with different residual motor skills.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation 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. | Other | Telerehabilitation with OS platforms |
Primary outcome
The opportunity of the usage TR in PD patients by using free open-source platforms
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
6 secondary outcomes
Patient's satisfaction
Time frame: 1 year
Patient's agreement
Time frame: 1 year
Maintenance of clinical outcomes - Walking speed
Time frame: 1 year
Maintenance of clinical outcomes - Balance
Time frame: 1 year
Maintenance of clinical outcomes - Risk of falling
Time frame: 1 year
Perceived level of quality of life
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The opportunity of the usage TR in PD patients by using free open-source platforms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.