Clinical trial NCT02098707: Effects of a Rehabilitation Treatment on Balance in PD Evaluated With a Stabilometric Platform
Official title: Effects of a Multidisciplinary Intensive Rehabilitation Treatment (MIRT) on Balance in Patients With Parkinson's Disease Evaluated With a Stabilometric Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Stabilometric Platform
Rehabilitation
Balance Disorders
Falls
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 58
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients (12 M, 18 F, mean age 66,8 ± 8,7) diagnosed with PD in stage 3 of Hoen\&Yahr (mean UPDRS III 18.8±10.5) according to the UK Brain Bank criteria.

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 \[OEC\]).

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.

Primary outcomes:
measure: Standard deviation (SD) of trunk sway
timeFrame: up to 4 weeks
Secondary outcomes:
measure: BBS scale
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Ospedale Generale di Zona "Moriggia-Pelascini"
state: Como
Study officials:
affiliation: Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References: