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

Parkinson Disease Clinical Trial

— SPPD002  

Official title:

Effects of a Multidisciplinary Intensive Rehabilitation Treatment (MIRT) on Balance in Patients With Parkinson's Disease Evaluated With a Stabilometric Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02098707
• Other study ID #: SP PD 002
• Secondary ID: SPPD002
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2014
• Last updated: March 24, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 58 Years to 74 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson 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	Standard deviation (SD) of trunk sway	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. We will also calculate 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 (counting, [OEC]). All physical measurements will be obtained during the ON phase of levodopa medication and at the same time of the day to reduce the influence of medication fluctuations. Statistical analysis with Wilcoxon signed rank test for non parametric data will be performed to analyze differences between T0 and T1 values of all variables. Results will be considered statistically significant for p < 0.05.	up to 4 weeks	Yes
Secondary	BBS scale	Berg Balance Scale	up to 4 weeks	Yes