Crossover Versus Stabilometric Platform in Parkinson's Disease

NCT ID: NCT02098577

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

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The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform.

Detailed Description

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Parkinson's disease (PD) is a neurodegenerative disorder characterized by different motor symptoms (rigidity, akinesia, tremor and impairment of balance and gait). Even though pharmacological treatment has changed the natural course of the disease, balance worsens over time and leads to falls. The aims of this study is to assess the efficacy of the crossover (group 1) on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform (group 2). The group 1 executed 6 days/week for a 4-weeks cycle a crossover protocol based on the first 4 level of resistance and a training which lasts at most 5 minutes. The group 2 executed 6 days/week for a 4-weeks cycle different exercises with the stabilometric platform in monopodalic and in bipodalic standing.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PD patients cross-over treatment

30 PD patients (according to Gelb et al) in Hoen\&Yahr stage 3, underwent cross-over treatment with the ability to walk without any assistance with mini-mental state examination score \>26.

Crossover

Intervention Type OTHER

Crossover cycle

PD patients stabilometric platform

30 PD patients (according to Gelb et al) in Hoen\&Yahr stage 3, underwent stabilometric platform treatment, with the ability to walk without any assistance with mini-mental state examination score \>26.

Stabilometric Platform

Intervention Type OTHER

This Stabilometric plate allows to assess the balance with an objective and reliable measurement, in both standard static or dynamic unstable condition

Interventions

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Crossover

Crossover cycle

Intervention Type OTHER

Stabilometric Platform

This Stabilometric plate allows to assess the balance with an objective and reliable measurement, in both standard static or dynamic unstable condition

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* PD in stage III Hoen\&Yahr according to Gelb et la. with the ability to walk without any assistance and with Mini Mental State Examination (MMSE) score \> 26

Exclusion Criteria

* MMSE \< 26
* Coexistence of other neurological diseases
* PD patients with relevant orthopedic, rheumatic and muscular conditions
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy

Locations

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Ospedale generale di zona "Moriggia-Pelascini"

Gravedona, Como, Italy

Site Status

Countries

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Italy

Other Identifiers

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PDvsCOPD

Identifier Type: OTHER

Identifier Source: secondary_id

PDvsCOPD

Identifier Type: -

Identifier Source: org_study_id

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