Analysis of the Parameters Obtained on Stabilometric Platform in Patients With PD

Parkinson's Disease Clinical Trial

— SPPD001  

Official title:

Analysis of the Parameters Obtained on Stabilometric Platform in Patients With Parkinson's Disease: a Basis for a Rehabilitation Perspective

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02098655
• Other study ID #: SP PD 001
• Secondary ID: SP PD 001
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2014
• Last updated: March 27, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: Giuseppe Frazzitta, MD
• Email: frazzittag62[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 58 Years to 74 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disturbance; Balance, Labyrinth
• Other Falls
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Stabilometric platform
Stabilometric platform is a device used for assessment and training of balance basing on ground reaction force evaluation in static conditions.

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona "Moriggia-Pelascini"	Gravedona	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	BBS	Berg Balance Scale	One week	Yes