- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02098655
Analysis of the Parameters Obtained on Stabilometric Platform in Patients With PD (SPPD001)
Analysis of the Parameters Obtained on Stabilometric Platform in Patients With Parkinson's Disease: a Basis for a Rehabilitation Perspective
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Como
-
Gravedona, Como, Italy, 22015
- Recruiting
- Ospedale Generale di Zona "Moriggia-Pelascini"
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Contact:
- Giuseppe Frazzitta, MD
- Phone Number: +39034492552
- Email: frazzittag62@gmail.com
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Principal Investigator:
- Giuseppe Frazzitta, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Stabilometric platform is a device used for assessment and training of balance basing on ground reaction force evaluation in static conditions.
|
|
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
|
Stabilometric platform is a device used for assessment and training of balance basing on ground reaction force evaluation in static conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BBS
Time Frame: One week
|
Berg Balance Scale
|
One week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giuseppe Frazzitta, MD, Parkinson disease and movement disorders rehabilitation unit, Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP PD 001 (Other Identifier: Ospedale Generale di Zona Moriggia-Pelascini)
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