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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02101528
Other study ID # CybexPD001
Secondary ID CybexPD001
Status Completed
Phase N/A
First received March 21, 2014
Last updated April 1, 2014
Start date January 2013
Est. completion date March 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

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.


Description:

An isokinetic muscle action is defined by its performance at a constant speed or velocity. The laboratory measurements of isokinetic strength provides torque measurements throughout the active range of motion during a maximal effort. Torque is the force rotating about an axis and is produced and recorded from the angular motion. Consequently, the peak torque is an index of the muscular strength. Isokinetic testing was introduced as a quantitative measurement of both statistic and dynamic muscular contraction in which all variables involved (resistance, limb velocity, joint position) are under control. This is because isokinetic muscle testing allows objective, valid, and reliable measurement of the force produced by skeletal muscle during exercise at constant velocity and accommodating resistance and it is appropriate for measuring muscle strength and muscle endurance across the disability spectrum.

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years to 79 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Atypical parkinsonisms

- PD patients with relevant orthopedic

- Rheumatic and muscular conditions

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Fondazione Salvatore Maugeri Montescano Pavia

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 Isokinetic strength Laboratory measurements of isokinetic strength One month Yes
Secondary Muscle functionality To establish whether a Intensive Rehabilitation Treatment change the muscle functionality in these patients, and to determine whether isokinetic dynamometry is a reliable method for evaluating muscle strength in patients with PD.
Muscle strength was measured in lower limbs with the subjects in a sitting position with hip flexed at 90°. To account for the influence of the gravity effect torque, data were corrected by the weight of the subject's lower limb at 45°. Subjects were tested at three fixed angular velocities: 90°/s, 120°/s, 180°/s. The subjects began each isokinetic contraction with the knee flexed at 90° and continued through the full range of motion. Peaks torque were obtained from the maximum isokinetic tests and subsequently analyzed.
One month Yes
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