Parkinson DiseaseSPPD002NCT02098707
Effects of a Rehabilitation Treatment on Balance in PD Evaluated With a Stabilometric Platform
An observational study of Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. Read more about this study
- Who is it for?
- Ages 58 to 74 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Stabilometric Platform
- How many people
- 30 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
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients (12 M, 18 F, mean age 66,8 ± 8,7) diagnosed with PD in stage 3 of Hoen\&Yahr (mean UPDRS III 18.8±10.5) according to the UK Brain Bank criteria.
Who may be able to join
- patients diagnosed with PD in stage 3 of Hoen \& Yahr according to the United Kingdom Brain Bank criteria.
Who cannot join
- Atypical parkinsonisms, patients with osteoarticular and muscular pathologies, PD patients with Mini Mental State Examination < 26, patients with other disorders of balance.
Trial locations and contacts
1 site in 1 country.
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: Effects of a Multidisciplinary Intensive Rehabilitation Treatment (MIRT) on Balance in Patients With Parkinson's Disease Evaluated With a Stabilometric Platform
Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in Parkinson Disease (PD).
Read the detailed description
Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of our multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in PD.
PD patients in stage 3 of Hoen \& Yahr will undergo clinical and instrumental evaluations at the beginning (T0) and at the end (T1) of the MIRT. Berg Balance Scale (BBS) will be performed to assess static and dynamic balance abilities. In order to determine some variables as index of postural stability, the investigators will use a stabilometric platform. With respect to the average centre of gravity the standard deviation (SD) of trunk sway will be calculated: total, in antero-posterior (AP) and in medio-lateral (ML) direction. The investigators can 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 will be calculated with open eyes (OE), and while the patient was performing a cognitive task (open eyes counting [OEC]).
- Conditions
- Parkinson Disease
- Being tested
- Stabilometric Platform
- Keywords
- Stabilometric Platform, Rehabilitation, Balance Disorders, Falls
- 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 Parkinson disease patients | 30 patients (12 M, 18 F, mean age 66,8 ± 8,7) diagnosed with PD in stage 3 of Hoen\&Yahr (mean Unified Parkinson Disease Rating Scale [UPDRS] III 18.8±10.5) will undergo a balance training 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.
Standard deviation (SD) of trunk sway
With respect to the average centre of gravity the standard deviation (SD) of trunk sway will be calculated: total, in antero-posterior [AP] and in medio-lateral [ML] direction. We will also calculate 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 will be calculated with open eyes (OE), and while the patient was performing a cognitive task (counting, [OEC]). All physical measurements will be obtained during the ON phase of levodopa medication and at the same time of the day to reduce the influence of medication fluctuations. Statistical analysis with Wilcoxon signed rank test for non parametric data will be performed to analyze differences between T0 and T1 values of all variables. Results will be considered statistically significant for p < 0.05.
Measured: up to 4 weeks
Secondary outcomes (1)
BBS scale
Berg Balance Scale
Measured: up to 4 weeks
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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, Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098707
- Sponsor's protocol ID
- SP PD 002
- Other IDs
- SPPD002
- Acronym
- SPPD002
- 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
- Effects of a Multidisciplinary Intensive Rehabilitation Treatment (MIRT) on Balance in Patients With Parkinson's Disease Evaluated With a Stabilometric Platform
- ClinicalTrials.gov ID
- NCT02098707
- Acronym / sponsor ID
- SPPD002 / SP PD 002
- Conditions
- Parkinson Disease
- Keywords
- Stabilometric Platform, Rehabilitation, Balance Disorders, Falls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 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.
Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in Parkinson Disease (PD).
Detailed description
Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in Parkinson's disease, whereas previous reports of physical interventions have suggested promising results. The investigators want to study the effects of our multidisciplinary intensive rehabilitation treatment (MIRT) on balance disorders in PD.
PD patients in stage 3 of Hoen \& Yahr will undergo clinical and instrumental evaluations at the beginning (T0) and at the end (T1) of the MIRT. Berg Balance Scale (BBS) will be performed to assess static and dynamic balance abilities. In order to determine some variables as index of postural stability, the investigators will use a stabilometric platform. With respect to the average centre of gravity the standard deviation (SD) of trunk sway will be calculated: total, in antero-posterior (AP) and in medio-lateral (ML) direction. The investigators can 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 will be calculated with open eyes (OE), and while the patient was performing a cognitive task (open eyes counting [OEC]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 Parkinson disease patients | – | Other: Stabilometric Platform30 patients (12 M, 18 F, mean age 66,8 ± 8,7) diagnosed with PD in stage 3 of Hoen\&Yahr (mean Unified Parkinson Disease Rating Scale [UPDRS] III 18.8±10.5) will undergo a balance training using a stabilometric platform. |
Who may qualify
- Ages
- 58 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients (12 M, 18 F, mean age 66,8 ± 8,7) diagnosed with PD in stage 3 of Hoen\&Yahr (mean UPDRS III 18.8±10.5) according to the UK Brain Bank criteria.
Key inclusion criteria (1 listed)
- patients diagnosed with PD in stage 3 of Hoen \& Yahr according to the United Kingdom Brain Bank criteria.
Key exclusion criteria (1 listed)
- Atypical parkinsonisms, patients with osteoarticular and muscular pathologies, PD patients with Mini Mental State Examination < 26, patients with other disorders of 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 | 30 Parkinson disease patients |
Primary outcome
Standard deviation (SD) of trunk sway
Time frame: up to 4 weeks
With respect to the average centre of gravity the standard deviation (SD) of trunk sway will be calculated: total, in antero-posterior [AP] and in medio-lateral [ML] direction. We will also calculate 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 will be calculated with open eyes (OE), and while the patient was performing a cognitive task (counting, [OEC]). All physical measurements will be obtained during the ON phase of levodopa medication and at the same time of the day to reduce the influence of medication fluctuations. Statistical analysis with Wilcoxon signed rank test for non parametric data will be performed to analyze differences between T0 and T1 values of all variables. Results will be considered statistically significant for p < 0.05.
1 secondary outcome
BBS scale
Time frame: up to 4 weeks
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 principal investigator
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 Disease, 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 1 inclusion and 1 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviation (SD) of trunk sway (time frame: up to 4 weeks). 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.