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Completed

NCT Number: NCT02098577

Crossover Versus Stabilometric Platform in Parkinson's Disease

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale generale di zona "Moriggia-Pelascini"

Gravedona, Como, 22015, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crossover

Other

Crossover cycle

Stabilometric Platform

Other

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

Primary outcomes

  1. BBS

    Time frame: One month

    Berg Balance Scale

Secondary outcomes

  1. 6MWT

    Time frame: One month

    Six minutes walking test

  2. TUG

    Time frame: One month

    Time up and Go test

  3. UPDRS II

    Time frame: One month

    Unified Parkinson's disease Rating Scale II

  4. UPDRS III

    Time frame: One month

    Unified Parkinson's disease Rating Scale III

Sponsors and collaborators

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Other

Registry information

Official study title

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

Acronym: PDvsCOPD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2014
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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