- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02101528
Determination of Muscle Strength in Parkinsonian Patients Through the Use of an Isokinetic Dynamometer (CybexPD001)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pavia
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Montescano, Pavia, Italy, 27100
- Fondazione Salvatore Maugeri
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients diagnosed with PD in stage 2-3 of Hoen&Yahr according to the United Kingdom Brain Bank criteria.
Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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Controls
age and sex matched healthy volunteers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Isokinetic strength
Time Frame: One month
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Laboratory measurements of isokinetic strength
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One month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle functionality
Time Frame: One month
|
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
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Collaborators and Investigators
Investigators
- Principal Investigator: Giuseppe Frazzitta, MD, Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CybexPD001 (Other Identifier: Ospedale Generale di Zona "Moriggia-Pelascini")
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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