NCT02101528

Brief Summary

Decreased muscle strength has been reported to be a factor contributing to increased incidences of falling in the elderly patients causing fractures, joint dislocations, severe soft tissue lesions and head trauma. Parkinson's Disease (PD) patients often complain of weakness and it has been reported that they have reduced muscle strength, decreased rate of force development, impaired ability to maintain constant force, and increased muscle coactivation during balance perturbation tasks. The specific cause of this weakness is not known, and in this study the investigators have analyzed and measured isokinetic muscle strength in PD patients to clarify this issue. The investigators have compared the data obtained with those of age-matched controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

March 21, 2014

Last Update Submit

April 1, 2014

Conditions

Keywords

Strength in PD patientsIsokinetic muscle strength

Outcome Measures

Primary Outcomes (1)

  • Isokinetic strength

    Laboratory measurements of isokinetic strength

    One month

Secondary Outcomes (1)

  • Muscle functionality

    One month

Study Arms (2)

PD Patients

PD patients with a diagnosis of "clinically probable" idiopathic PD in Hoehn-Yahr stage 2-3, with the ability to walk without any assistance, with mini-mental state examination score ≥26, without any relevant comorbidity or vestibular/visual dysfunctions limiting locomotion or balance.

Controls

age and sex matched healthy volunteers

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with PD in stage 2-3 of Hoen\&Yahr according to the United Kingdom Brain Bank criteria. Healthy Volunteers

You may qualify if:

  • PD in stage 2-3 of Hoen\&Yahr according to the United Kingdom Brain Bank criteria.

You may not qualify if:

  • Atypical parkinsonisms
  • PD patients with relevant orthopedic
  • Rheumatic and muscular conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Salvatore Maugeri

Montescano, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Giuseppe Frazzitta, MD

    Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 2, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

April 2, 2014

Record last verified: 2014-03

Locations