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

NCT02098707 | Unknown DMC

• 2 other identifiers: SP PD 002SPPD002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Keywords

Stabilometric Platform; Rehabilitation; Balance Disorders; Falls

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• BBS scale

  up to 4 weeks

Study Arms (1)

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.

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.

30 Parkinson disease patients

Eligibility Criteria

• Age: 58 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

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

  PRINCIPAL INVESTIGATOR

Study Design

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