Parkinson's DiseaseSPPD001NCT02098655
Analysis of the Parameters Obtained on Stabilometric Platform in Patients With PD
An observational study of Parkinson's Disease and Disturbance; Balance, Labyrinth, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
Objective: To analyze different parameters in patients with Parkinson's Disease (PD) obtained through the use of a stabilometric platform and compare them with those of a control population. Read more about this study
- Who is it for?
- Ages 58 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Disturbance; Balance, Labyrinth, Other Falls
- What is being tested?
- Stabilometric platform
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Jun 2014
- 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 58 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease and healthy volunteers.
Who may be able to join
- PD according to Gelb et al., in Hoehn-Yahr stage 3, with the ability to walk without any assistance, who had fallen in the last year at least 2 times, with mini-mental state examination score ≥26.
- Healthy volunteers
Who cannot join
- atypical parkinsonism
- patients with cerebro-vascular disorders or other neurological conditions including cognitive impairment.
- patients with relevant comorbidity or vestibular/visual dysfunctions limiting locomotion or balance.
Trial locations and contacts
1 site in 1 country.
Giuseppe Frazzitta, MD contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale Generale di Zona "Moriggia-Pelascini"
Gravedona, Como, 22015
Giuseppe Frazzitta, MD, +39034492552, frazzittag62@gmail.com
Giuseppe Frazzitta, MD
About this study
Official title: Analysis of the Parameters Obtained on Stabilometric Platform in Patients With Parkinson's Disease: a Basis for a Rehabilitation Perspective
Objective: To analyze different parameters in patients with Parkinson's Disease (PD) obtained through the use of a stabilometric platform and compare them with those of a control population. To interpret the data in order to find some postural instability indicators that can become useful to build a rehabilitation strategy for balance disorders in PD.
Read the detailed description
Background: Posture and balance are the foundation on wich upright stance and walking are executed. Postural instability is the impairment in balance that compromises the ability to maintain or change posture such as standing and walking. It is considered to be one of the cardinal features of PD. In such patients it is present even at diagnosis and worsens with disease progression. It correlates with falls representing a major source of disability and reduced QoL in PD. In this course, the study of balance is important to identify patients who can benefit from specific rehabilitative treatment.
Objective: To analyze different parameters in patients with PD obtained through the use of a stabilometric platform and compare them with those of a control population. To interpret the data in order to find some postural instability indicators that can become useful to build a rehabilitation strategy for balance disorders in PD.
- Being tested
- Stabilometric platform
- Keywords
- Stabilometric Platform, Postural instability
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilometric platformOther
Stabilometric platform is a device used for assessment and training of balance basing on ground reaction force evaluation in static conditions.
| Study group | Role | What they receive |
|---|---|---|
| 30 patients with PD | 30 patients (12 M, 18 F, mean age 66,8 ± 8,7) with PD in stage 3 of H\&Y will undergo training of balance using a stabilometric platform Receives: Other: Stabilometric platform | |
| 12 healthy volunteers | 12 healthy volunteers (3 M, 9 F, mean age 66,5 ± 6,0) served as controls will undergo training of balance using a stabilometric platform Receives: Other: Stabilometric platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk sway
With respect to the average centre of gravity the Standard Deviation of trunk sway (total, in Antero-Posterior and in Medio-Lateral direction) were calculated. In this way it was possible to obtain a statokinesigram, that is the layout of a line connecting the successive positions of the center of pressure during the recording, and the area of the ellipse containing 90% of the sampled positions of the center of pressure. These measurements were obtained with open eyes (OE), and while the patient performing a cognitive task (counting).
Measured: One week
Secondary outcomes (1)
BBS
Berg Balance Scale
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Parkinson disease and movement disorders rehabilitation unit, Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098655
- Sponsor's protocol ID
- SP PD 001
- Other IDs
- SP PD 001
- Acronym
- SPPD001
- Status last verified
- Mar 2014
- First submitted
- 21 Mar 2014
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Parameters Obtained on Stabilometric Platform in Patients With Parkinson's Disease: a Basis for a Rehabilitation Perspective
- ClinicalTrials.gov ID
- NCT02098655
- Acronym / sponsor ID
- SPPD001 / SP PD 001
- Keywords
- Stabilometric Platform, Postural instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 28 Mar 2014 (estimated)
- 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.
Objective: To analyze different parameters in patients with Parkinson's Disease (PD) obtained through the use of a stabilometric platform and compare them with those of a control population. To interpret the data in order to find some postural instability indicators that can become useful to build a rehabilitation strategy for balance disorders in PD.
Detailed description
Background: Posture and balance are the foundation on wich upright stance and walking are executed. Postural instability is the impairment in balance that compromises the ability to maintain or change posture such as standing and walking. It is considered to be one of the cardinal features of PD. In such patients it is present even at diagnosis and worsens with disease progression. It correlates with falls representing a major source of disability and reduced QoL in PD. In this course, the study of balance is important to identify patients who can benefit from specific rehabilitative treatment.
Objective: To analyze different parameters in patients with PD obtained through the use of a stabilometric platform and compare them with those of a control population. To interpret the data in order to find some postural instability indicators that can become useful to build a rehabilitation strategy for balance disorders in PD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 patients with PD | – | Other: Stabilometric platform30 patients (12 M, 18 F, mean age 66,8 ± 8,7) with PD in stage 3 of H\&Y will undergo training of balance using a stabilometric platform |
| 12 healthy volunteers | – | Other: Stabilometric platform12 healthy volunteers (3 M, 9 F, mean age 66,5 ± 6,0) served as controls will undergo training of balance using a stabilometric platform |
Who may qualify
- Ages
- 58 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease and healthy volunteers.
Key inclusion criteria (2 listed)
- PD according to Gelb et al., in Hoehn-Yahr stage 3, with the ability to walk without any assistance, who had fallen in the last year at least 2 times, with mini-mental state examination score ≥26.
- Healthy volunteers
Key exclusion criteria (3 listed)
- atypical parkinsonism
- patients with cerebro-vascular disorders or other neurological conditions including cognitive impairment.
- patients with relevant comorbidity or vestibular/visual dysfunctions limiting locomotion or balance.
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 |
|---|---|---|
| Stabilometric platformStabilometric platform is a device used for assessment and training of balance basing on ground reaction force evaluation in static conditions. | Other | 12 healthy volunteers, 30 patients with PD |
Primary outcome
Trunk sway
Time frame: One week
With respect to the average centre of gravity the Standard Deviation of trunk sway (total, in Antero-Posterior and in Medio-Lateral direction) were calculated. In this way it was possible to obtain a statokinesigram, that is the layout of a line connecting the successive positions of the center of pressure during the recording, and the area of the ellipse containing 90% of the sampled positions of the center of pressure. These measurements were obtained with open eyes (OE), and while the patient performing a cognitive task (counting).
1 secondary outcome
BBS
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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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.
Giuseppe Frazzitta, MD contact
Giuseppe Frazzitta, MD principal investigator
Parkinson disease and movement disorders rehabilitation unit, Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
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's Disease and Disturbance; Balance, Labyrinth, run by Ospedale Generale Di Zona Moriggia-Pelascini 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 2 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: status not confirmed, as of the sponsor's last update on 28 Mar 2014. 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 Giuseppe Frazzitta, MD (frazzittag62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk sway (time frame: One week). 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 28 Mar 2014.