Effects of a Rehabilitation Treatment on Balance in PD Evaluated With a Stabilometric Platform

NCT ID: NCT02098707

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

Brief 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. 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]).

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Stabilometric Platform

Intervention Type: OTHER

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

Interventions

Stabilometric Platform

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients diagnosed with PD in stage 3 of Hoen & Yahr according to the United Kingdom Brain Bank criteria.

Exclusion Criteria

Atypical parkinsonisms, patients with osteoarticular and muscular pathologies, PD patients with Mini Mental State Examination < 26, patients with other disorders of balance.

• Minimum Eligible Age: 58 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy

Locations

Ospedale Generale di Zona "Moriggia-Pelascini"

Gravedona, Como, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giuseppe Frazzitta, MD

Role: primary

frazzittag62@gmail.com

+39034492552

Other Identifiers

SPPD002

Identifier Type: OTHER

Identifier Source: secondary_id

SP PD 002

Identifier Type: -

Identifier Source: org_study_id