Crossover Versus Stabilometric Platform in Parkinson's Disease

Parkinson's Disease Clinical Trial

— PDvsCOPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098577
• Other study ID #: PDvsCOPD
• Secondary ID: PDvsCOPD
• Status: Completed
• Phase: N/A
• First received: March 22, 2014
• Last updated: March 27, 2014
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Crossover
Crossover cycle
• Stabilometric Platform
This Stabilometric plate allows to assess the balance with an objective and reliable measurement, in both standard static or dynamic unstable condition

Locations

Country	Name	City	State
Italy	Ospedale generale di zona "Moriggia-Pelascini"	Gravedona	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BBS	Berg Balance Scale	One month	Yes
Secondary	6MWT	Six minutes walking test	One month	Yes
Secondary	TUG	Time up and Go test	One month	Yes
Secondary	UPDRS II	Unified Parkinson's disease Rating Scale II	One month	Yes
Secondary	UPDRS III	Unified Parkinson's disease Rating Scale III	One month	Yes