Parkinson DiseaseNCT05329987
Analysis of Postural Transitions in Subjects Affected by Parkinson Disease
An observational study of Parkinson Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. 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?
- Rehabilitation
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 18 May 2022to 1 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of subjects affected by Parkinson Disease
Who may be able to join
- Subjects with Idiopathic Parkinson's Disease;
- Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
- Subjects must be able to walk at least 10 meters independently with or without any walking aid
Who cannot join
- Non-clinically stable subjects;
- Subjects in OFF phase during the evaluations;
- Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
- Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.
- Conditions
- Parkinson Disease
- Being tested
- Rehabilitation
- Keywords
- Parkinson Disease, Rehabilitation, Postural Transfers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Intervention focused on balance, gait and postural transfers rehabilitation. 20 session of 90 minutes (60 minutes of physiotherapy and 30 minutes of occupational therapy), 2 times a week, for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease | Rehabilitation according to Physiotherapy and Occupational Therapy European Guidelines for Parkinson Disease. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in execution time of Postural Transfers
The execution time is measured via an inertial measurement unit attached to the back of the patient
Measured: Change from Baseline at 10 weeks
Change of execution velocity of Postural Transfers
The execution velocity is measured via an inertial measurement unit attached to the back of the patient. Specifically the velocity are measured as the Root Mean Square of gyroscope signal.
Measured: Change from Baseline at 10 weeks
Change of antero-posterior acceleration during Postural Transfers execution
The antero-posterior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Measured: Change from Baseline at 10 weeks
Change of superior-inferior acceleration during Postural Transfers execution
The superior inferior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Measured: Change from Baseline at 10 weeks
Secondary outcomes (4)
Change in Time Up and Go Test
Measured: Change from baseline at 10 weeks
Change in 10 meter walking test
Measured: Change from baseline at 10 weeks
Change in Berg Balance Scale Score
Measured: Change from baseline at 10 weeks
Change in Short-Form 12 score
Measured: Change from baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start18 May 2022
- Primary completion1 Apr 2024
- Study completion1 Aug 2024
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 Fondazione Don Carlo Gnocchi ETSThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riccardo Buraschi, PT, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329987
- Sponsor's protocol ID
- FDG_PosTrans
- Status last verified
- Aug 2024
- First submitted
- 4 Apr 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Postural Transitions in Subjects Affected by Parkinson Disease
- ClinicalTrials.gov ID
- NCT05329987
- Acronym / sponsor ID
- FDG_PosTrans
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Rehabilitation, Postural Transfers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 15 Apr 2022 (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.
This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease | – | Other: RehabilitationRehabilitation according to Physiotherapy and Occupational Therapy European Guidelines for Parkinson Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of subjects affected by Parkinson Disease
Key inclusion criteria (3 listed)
- Subjects with Idiopathic Parkinson's Disease;
- Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
- Subjects must be able to walk at least 10 meters independently with or without any walking aid
Key exclusion criteria (4 listed)
- Non-clinically stable subjects;
- Subjects in OFF phase during the evaluations;
- Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
- Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)
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 |
|---|---|---|
| RehabilitationIntervention focused on balance, gait and postural transfers rehabilitation. 20 session of 90 minutes (60 minutes of physiotherapy and 30 minutes of occupational therapy), 2 times a week, for 10 weeks. | Other | Parkinson Disease |
Primary outcome
Change in execution time of Postural Transfers
Time frame: Change from Baseline at 10 weeks
The execution time is measured via an inertial measurement unit attached to the back of the patient
Change of execution velocity of Postural Transfers
Time frame: Change from Baseline at 10 weeks
The execution velocity is measured via an inertial measurement unit attached to the back of the patient. Specifically the velocity are measured as the Root Mean Square of gyroscope signal.
Change of antero-posterior acceleration during Postural Transfers execution
Time frame: Change from Baseline at 10 weeks
The antero-posterior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Change of superior-inferior acceleration during Postural Transfers execution
Time frame: Change from Baseline at 10 weeks
The superior inferior acceleration is measured via an inertial measurement unit attached to the back of the patient.
4 secondary outcomes
Change in Time Up and Go Test
Time frame: Change from baseline at 10 weeks
Change in 10 meter walking test
Time frame: Change from baseline at 10 weeks
Change in Berg Balance Scale Score
Time frame: Change from baseline at 10 weeks
Change in Short-Form 12 score
Time frame: Change from baseline at 10 weeks
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 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Riccardo Buraschi, PT principal investigator
IRCCS Fondazione Don Carlo Gnocchi
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 Fondazione Don Carlo Gnocchi ETS 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 3 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: finished, as of the sponsor's last update on 9 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?
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?
Change in execution time of Postural Transfers (time frame: Change from Baseline at 10 weeks). 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 9 Aug 2024.