Parkinson DiseasePD-REHAB-NETNCT06052280
Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation
A study testing Telerehabilitation exercise program and Home self-exercise program in people with Parkinson Disease, run by Azienda Sanitaria Locale CN1 Cuneo at 1 site in Italy.
Trial summary
The Parkinson TELEREHABilitation-NET pilot study (Parkinson TELEREHAB-NET) is designed to observe and monitor PD patients in their initial phase (which includes the period from the onset of motor symptoms until the onset of motor fluctuations) and to assess the feasibility of an integrated multidimensional approach in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Telerehabilitation exercise program and Home self-exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2023to Oct 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General:
- adults, aged 18 or older;
- medical diagnosis of idiopathic PD according the most recent Movement Disorder Society diagnostic criteria;
- disease stage ≤ 2 on the Hoehn\&Yahr scale;
- Montreal Cognitive Assessment score >25;
- ability to read, understand and provide a written informed consent, in accordance with good clinical practice and local regulations;
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- motivation and possibility to show up for planned controls and to comply with the requested study procedures.
- Specific for TrE arm:
- wireless internet access at home;
- adequate room to place telerehabilitation device (about 2 meters in front of device monitor).
Who cannot join
- <18 years of age;
- Any atypical, iatrogenic, or secondary Parkinsonism;
- Disease stage > 2 on the Hoehn\&Yahr scale;
- Any severe orthopaedic, vascular, respiratory, or cardiac problems or any other medical condition that, in the principal investigator's opinion, could limit participation in moderate exercise or the study protocol.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria Locale CN1
Cuneo, 12030
Federica Gallo, Biostatistic, 0172699235, federica.gallo@aslcn1.it
Elona Bahimi, Neurologist, 0174676121, elona.brahimi@aslcn1.it
About this study
Official title: Management of Initial Parkinson's Disease: a Prospective, Mono-centric, no Profit Pilot Clinical Trial Comparing Conventional Face-to-face Physiotherapy and Home-based Telerehabilitation
The Parkinson TELEREHABilitation-NET pilot study (Parkinson TELEREHAB-NET) is designed to observe and monitor PD patients in their initial phase (which includes the period from the onset of motor symptoms until the onset of motor fluctuations) and to assess the feasibility of an integrated multidimensional approach in treating and managing PD patients in a local clinical setting (ASL CN1). Chiefly, through this pilot study, feasibility and acceptability of the general experimental plan, as well as the potential for positive effects of physiotherapy in early PD patients will be assessed.
So, this pilot study primarily aims at:
Read more
- validating the feasibility of the study protocol, assessing participants' inclusion and exclusion criteria, testing instruments/procedures used for home rehabilitation (both for the Telerehabilitation Exercise group - TrE arm and for the Home Self-Exercise group - HSE arm), testing the suitability of the method for data collection;
- obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms;
- evaluating appropriateness of the consent form, recruitment potentials, time needed to receive written consent, and the required number of researchers/medical specialists/physiotherapists needed to cover the whole study path;
- assessing patients' acceptability of the intervention, through the evaluation of the adherence to rehabilitation process (in both arms), the completeness of proposed measurements, and compliance at follow-up.
Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales, after completing the whole rehabilitation path (described below) compared to baseline level, and maintenance of results over time.
- Conditions
- Parkinson Disease
- Being tested
- Telerehabilitation exercise program, Home self-exercise program
- Keywords
- Parkinson Disease, Telerehabilitation, Physical Activity, Physical Therapy Modalities
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation exercise programOther
Also called Virtual self-exercise program
After the outpatient intensive physical therapy program (common to both study arms), patients in the TrE group will continue with prescribed self-training at home through telerehabilitation, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down.
The TrE arm will be supported by a telerehabilitation device which will be installed and tested at the patients' home immediately after the outpatient intensive program. The device will track any access and exercise duration, so that the physiotherapists will be able to remotely monitor both the actual duration of each session and their weekly frequency. One session per week will be directly and online supervised by a physiotherapist, while the other two will be recorded only.
Home self-exercise programOther
Also called Conventional self-exercise program
After the outpatient intensive physical therapy program (common to both study arms), patients in the HSE group will continue with prescribed self-training at home, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down.
The HSE arm will be given a booklet containing detailed explanations and pictures of the assigned exercises, in order to guide them in the correct execution of the requested movements. Subjects in this group will be asked to fill in a training diary to keep track of the training sessions and their duration. Once a week a physiotherapist will contact patients to discuss possible problems encountered in performing the exercises and to help in solving them.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Exercise group (TrE arm) | Experimental | Not described Receives: Other: Telerehabilitation exercise program |
| Home Self-Exercise group (HSE arm) | Active comparator | Not described Receives: Other: Home self-exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study recruitment potentials
total number of enrolled subjects / total number of eligible subjects
Measured: baseline
Single arm recruitment potentials
arm-specific number of enrolled subjects / arm-specific number of eligible subjects
Measured: baseline
Adherence to study path
drop-out rate at each single step, total and by arm
Measured: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)
Compliance to interventions
number of fulfilled visits / number of scheduled visits
Measured: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)
Secondary outcomes (13)
Cognitive functions
Possible patients' changes in Montreal Cognitive Assessment. This scale ranges from 0 to 30 points, with higher scores meaning a better outcome.
Measured: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Freezing of gait
Possible patients' changes in Freezing of Gait Questionnaire. This scale ranges from 0 to 24 points, with higher scores meaning a worse outcome.
Measured: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Movement disorders
Possible patients' changes in Movement Disorder Scale (parts 1, 2, 3, and 4). This scale ranges from 0 to 260 points, with higher scores meaning a worse outcome.
Measured: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Postural control
Possible patients' changes in Mini-Balance Evaluation System Test. This scale ranges from 0 to 28 points, with higher scores meaning a better outcome.
Measured: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Sensory orientation
Possible patients' changes in Non-Motor Symptom Scale. This scale ranges from 0 to 360 points, with higher scores meaning a worse outcome.
Measured: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Quality of life perception
Possible patients' changes in Parkinson's Disease Quality of Life Questionnaire. This scale ranges from 0 to 32 points, with higher scores meaning a worse outcome.
Measured: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Walking ability
Possible patients' changes in 6-minute walking test. This test measures how many meters the patient can cover in 6 minutes. The minimum is 0 meter, the maximum is not pre-specified; a longer distance means a better outcome.
Measured: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Transition ability between sitting and standing
Possible patients' changes in 5-time sit-to-stand test. This test measures in how many seconds the patient manages to sit and stand for 5 times. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome.
Measured: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Backward walking ability
Possible patients' changes in 3-meter backward walking test. This test measures in how many seconds the patient manages to walk backward for a 3 meters distance. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome.
Measured: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Turning ability
Possible patients' changes in 360° turn right-to-left test. This test measures in how many seconds the patient manages to perform a complete 360° turn from right to left. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome.
Measured: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Manual dexterity
Possible patients' changes in Coin rotation test. This test measures how many times the patient manages to turn a coin (of 25 millimeters in diameter) in 30 seconds. The minimum is 0, the maximum is not pre-specified; more the times better the outcome.
Measured: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Transition ability between standing and prone position
Possible patients' changes in Stand-prone-stand test. This test measures in how many seconds the patient takes to change position from standing to prone to standing again. Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome.
Measured: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Dynamic stability
Possible patients' changes in 4-square-step test. This test measures in how many seconds the patient sequentially steps over four delimited areas (1 square meter large). Minimum and maximum time lengths are not pre-specified; a higher time means a worse outcome.
Measured: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start9 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study is designed to assess the feasibility of the integrated multidimensional approach in treating and rehabilitating PD patients in a local clinical setting, both for the Telerehabilitation Exercise (TrE) arm and for the Home Self-Exercise (HSE) arm, by: 1. assessing participants' inclusion/exclusion criteria, testing instruments/procedures, testing data collection method; 2. obtaining preliminary data to estimate sample size for the primary outcome, in both arms; 3. evaluating appropriateness of the consent form, recruitment potentials, and the required number of researchers needed for study management; 4. assessing patients' acceptability of the intervention and their compliance. Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale CN1 Cuneo
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elona Brahimi, MD, Principal investigator, Neurology Unit, Movement Disorders Clinic , Local Health Authority, ASL Cuneo 1, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052280
- Sponsor's protocol ID
- Resolution 982 of May 16, 2023
- Acronym
- PD-REHAB-NET
- Status last verified
- Aug 2024
- First submitted
- 11 Sep 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Initial Parkinson's Disease: a Prospective, Mono-centric, no Profit Pilot Clinical Trial Comparing Conventional Face-to-face Physiotherapy and Home-based Telerehabilitation
- ClinicalTrials.gov ID
- NCT06052280
- Acronym / sponsor ID
- PD-REHAB-NET / Resolution 982 of May 16, 2023
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Telerehabilitation, Physical Activity, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale CN1 CuneoOther government
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 25 Sep 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.
The Parkinson TELEREHABilitation-NET pilot study (Parkinson TELEREHAB-NET) is designed to observe and monitor PD patients in their initial phase (which includes the period from the onset of motor symptoms until the onset of motor fluctuations) and to assess the feasibility of an integrated multidimensional approach in treating and managing PD patients in a local clinical setting (ASL CN1). Chiefly, through this pilot study, feasibility and acceptability of the general experimental plan, as well as the potential for positive effects of physiotherapy in early PD patients will be assessed.
So, this pilot study primarily aims at:
- validating the feasibility of the study protocol, assessing participants' inclusion and exclusion criteria, testing instruments/procedures used for home rehabilitation (both for the Telerehabilitation Exercise group - TrE arm and for the Home Self-Exercise group - HSE arm), testing the suitability of the method for data collection;
- obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms;
- evaluating appropriateness of the consent form, recruitment potentials, time needed to receive written consent, and the required number of researchers/medical specialists/physiotherapists needed to cover the whole study path;
- assessing patients' acceptability of the intervention, through the evaluation of the adherence to rehabilitation process (in both arms), the completeness of proposed measurements, and compliance at follow-up.
Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales, after completing the whole rehabilitation path (described below) compared to baseline level, and maintenance of results over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This pilot study is designed to assess the feasibility of the integrated multidimensional approach in treating and rehabilitating PD patients in a local clinical setting, both for the Telerehabilitation Exercise (TrE) arm and for the Home Self-Exercise (HSE) arm, by: 1. assessing participants' inclusion/exclusion criteria, testing instruments/procedures, testing data collection method; 2. obtaining preliminary data to estimate sample size for the primary outcome, in both arms; 3. evaluating appropriateness of the consent form, recruitment potentials, and the required number of researchers needed for study management; 4. assessing patients' acceptability of the intervention and their compliance. Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Exercise group (TrE arm) | Experimental | Other: Telerehabilitation exercise program |
| Home Self-Exercise group (HSE arm) | Active comparator | Other: Home self-exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- adults, aged 18 or older;
- medical diagnosis of idiopathic PD according the most recent Movement Disorder Society diagnostic criteria;
- disease stage ≤ 2 on the Hoehn\&Yahr scale;
- Montreal Cognitive Assessment score >25;
- ability to read, understand and provide a written informed consent, in accordance with good clinical practice and local regulations;
Key exclusion criteria (4 listed)
- <18 years of age;
- Any atypical, iatrogenic, or secondary Parkinsonism;
- Disease stage > 2 on the Hoehn\&Yahr scale;
- Any severe orthopaedic, vascular, respiratory, or cardiac problems or any other medical condition that, in the principal investigator's opinion, could limit participation in moderate exercise or the study protocol.
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 exercise programAlso: Virtual self-exercise programAfter the outpatient intensive physical therapy program (common to both study arms), patients in the TrE group will continue with prescribed self-training at home through telerehabilitation, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down. The TrE arm will be supported by a telerehabilitation device which will be installed and tested at the patients' home immediately after the outpatient intensive program. The device will track any access and exercise duration, so that the physiotherapists will be able to remotely monitor both the actual duration of each session and their weekly frequency. One session per week will be directly and online supervised by a physiotherapist, while the other two will be recorded only. | Other | Telerehabilitation Exercise group (TrE arm) |
| Home self-exercise programAlso: Conventional self-exercise programAfter the outpatient intensive physical therapy program (common to both study arms), patients in the HSE group will continue with prescribed self-training at home, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down. The HSE arm will be given a booklet containing detailed explanations and pictures of the assigned exercises, in order to guide them in the correct execution of the requested movements. Subjects in this group will be asked to fill in a training diary to keep track of the training sessions and their duration. Once a week a physiotherapist will contact patients to discuss possible problems encountered in performing the exercises and to help in solving them. | Other | Home Self-Exercise group (HSE arm) |
Primary outcome
Study recruitment potentials
Time frame: baseline
total number of enrolled subjects / total number of eligible subjects
Single arm recruitment potentials
Time frame: baseline
arm-specific number of enrolled subjects / arm-specific number of eligible subjects
Adherence to study path
Time frame: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)
drop-out rate at each single step, total and by arm
Compliance to interventions
Time frame: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)
number of fulfilled visits / number of scheduled visits
13 secondary outcomes
Cognitive functions
Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Freezing of gait
Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Movement disorders
Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Postural control
Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Sensory orientation
Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Quality of life perception
Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)
Walking ability
Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Transition ability between sitting and standing
Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Backward walking ability
Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Turning ability
Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Manual dexterity
Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Transition ability between standing and prone position
Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Dynamic stability
Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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.
Elona Brahimi, MD principal investigator
Neurology Unit, Movement Disorders Clinic , Local Health Authority, ASL Cuneo 1, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation exercise program and Home self-exercise program in people with Parkinson Disease, run by Azienda Sanitaria Locale CN1 Cuneo 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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federica Gallo, Biostatistic (+390174676121, federica.gallo@aslcn1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study recruitment potentials (time frame: baseline). The study lists 4 primary outcomes in all. 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 6 Aug 2024.