Crossover Versus Stabilometric Platform in Parkinson's Disease (PDvsCOPD)

March 27, 2014 updated by: Ospedale Generale Di Zona Moriggia-Pelascini

Effect of Two Different Rehabilitation Programs on Balance in Parkinsonian Patients: Crossover Versus Stabilometric Platform

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Como
      • Gravedona, Como, Italy, 22015
        • Ospedale Generale di Zona "Moriggia-Pelascini"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

60 patients with 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Crossover
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BBS
Time Frame: One month
Berg Balance Scale
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6MWT
Time Frame: One month
Six minutes walking test
One month
TUG
Time Frame: One month
Time up and Go test
One month
UPDRS II
Time Frame: One month
Unified Parkinson's disease Rating Scale II
One month
UPDRS III
Time Frame: One month
Unified Parkinson's disease Rating Scale III
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

March 22, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (ESTIMATE)

March 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 27, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDvsCOPD (OTHER: Ospedale generale di zona "Moriggia-Pelascini")

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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