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

NCT ID: NCT02098655

Last Updated: 2014-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Background: Posture and balance are the foundation on wich upright stance and walking are executed. Postural instability is the impairment in balance that compromises the ability to maintain or change posture such as standing and walking. It is considered to be one of the cardinal features of PD. In such patients it is present even at diagnosis and worsens with disease progression. It correlates with falls representing a major source of disability and reduced QoL in PD. In this course, the study of balance is important to identify patients who can benefit from specific rehabilitative treatment.

Objective: To analyze different parameters in patients with 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

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Parkinson's Disease Disturbance; Balance, Labyrinth Other Falls

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

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.

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

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

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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

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

58 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Ospedale Generale di Zona "Moriggia-Pelascini"

Gravedona, Como, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Frazzitta, MD

Role: CONTACT

Facility Contacts

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Giuseppe Frazzitta, MD

Role: primary

+39034492552

Other Identifiers

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SP PD 001

Identifier Type: OTHER

Identifier Source: secondary_id

SP PD 001

Identifier Type: -

Identifier Source: org_study_id

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