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

NCT02098655 | Unknown DMC

• 1 other identifier: SP PD 001
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Stabilometric Platform; Postural instability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• BBS

  One week

Study Arms (2)

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

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

Interventions

Stabilometric platform OTHER

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

12 healthy volunteers; 30 patients with PD

Eligibility Criteria

• Age: 58 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease and healthy volunteers.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

Ospedale Generale di Zona "Moriggia-Pelascini"

Gravedona, Como, 22015, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Giuseppe Frazzitta, MD

  Parkinson disease and movement disorders rehabilitation unit, Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Frazzitta, MD

CONTACT

frazzittag62@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 28, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

IT (1)