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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease; Disturbance; Balance, Labyrinth; Other Falls
• Intervention / Treatment: Other: Stabilometric platform

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: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

Study Locations

• Italy
  • Como
    • Gravedona, Como, Italy, 22015
      • Recruiting
      • Ospedale Generale di Zona "Moriggia-Pelascini"
      • Contact: Giuseppe Frazzitta, MD; Phone Number: +39034492552; Email: frazzittag62@gmail.com
      • Principal Investigator: Giuseppe Frazzitta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease and healthy volunteers.

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?

Number of groups / cohorts

2

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	Other: 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	Other: 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	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	Berg Balance Scale	One week

Collaborators and Investigators

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
• 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: June 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): March 28, 2014

Study Record Updates

• Last Update Posted (Estimate): March 28, 2014
• Last Update Submitted That Met QC Criteria: March 27, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Postural instability; Stabilometric Platform
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: SP PD 001 (Other Identifier: Ospedale Generale di Zona Moriggia-Pelascini)