NCT02098577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

8 months

First QC Date

March 22, 2014

Last Update Submit

March 27, 2014

Conditions

Keywords

Balance

Outcome Measures

Primary Outcomes (1)

  • BBS

    Berg Balance Scale

    One month

Secondary Outcomes (4)

  • 6MWT

    One month

  • TUG

    One month

  • UPDRS II

    One month

  • UPDRS III

    One month

Study Arms (2)

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

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

Interventions

Crossover cycle

PD patients cross-over treatment

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

PD patients stabilometric platform

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • MMSE \< 26
  • Coexistence of other neurological diseases
  • PD patients with relevant orthopedic, rheumatic and muscular conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale generale di zona "Moriggia-Pelascini"

Gravedona, Como, 22015, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Crossing Over, Genetic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Homologous RecombinationRecombination, GeneticGenetic Phenomena

Study Officials

  • Giuseppe Frazzitta, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2014

First Posted

March 28, 2014

Study Start

June 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations