Crossover Versus Stabilometric Platform in Parkinson's Disease

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Crossover; Other: Stabilometric Platform

• Registration Number: NCT02098577
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

Brief Summary

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

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 Timeline

• Study Start: 2013-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-22
• Study First Submitted QC: 2014-03-27
• Last Update Submitted: 2014-03-27
• Study First Posted: 2014-03-28
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PD patients cross-over treatment	Crossover	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.
PD patients stabilometric platform	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.

Primary Outcome Measures

Name	Time	Method
BBS	One month	Berg Balance Scale

Secondary Outcome Measures

Name	Time	Method
6MWT	One month	Six minutes walking test
TUG	One month	Time up and Go test
UPDRS II	One month	Unified Parkinson's disease Rating Scale II
UPDRS III	One month	Unified Parkinson's disease Rating Scale III

Trial Locations

Locations (1)

Ospedale generale di zona "Moriggia-Pelascini"; 🇮🇹 Gravedona, Como, Italy