Parkinson's DiseaseCybexPD001NCT02101528
Determination of Muscle Strength in Parkinsonian Patients Through the Use of an Isokinetic Dynamometer
An observational study of Parkinson's Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with PD in stage 2-3 of Hoen\&Yahr according to the United Kingdom Brain Bank criteria. Healthy Volunteers
Who may be able to join
- PD in stage 2-3 of Hoen\&Yahr according to the United Kingdom Brain Bank criteria.
Who cannot join
- Atypical parkinsonisms
- PD patients with relevant orthopedic
- Rheumatic and muscular conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Keywords
- Strength in PD patients, Isokinetic muscle strength
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic strength
Laboratory measurements of isokinetic strength
Measured: One month
Secondary outcomes (1)
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101528
- Sponsor's protocol ID
- CybexPD001
- Other IDs
- CybexPD001
- Acronym
- CybexPD001
- Status last verified
- Mar 2014
- First submitted
- 21 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Muscle Strength in Parkinsonian Patients Through the Use of an Isokinetic Dynamometer
- ClinicalTrials.gov ID
- NCT02101528
- Acronym / sponsor ID
- CybexPD001 / CybexPD001
- Conditions
- Parkinson's Disease
- Keywords
- Strength in PD patients, Isokinetic muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with PD in stage 2-3 of Hoen\&Yahr according to the United Kingdom Brain Bank criteria. Healthy Volunteers
Key inclusion criteria (1 listed)
- PD in stage 2-3 of Hoen\&Yahr according to the United Kingdom Brain Bank criteria.
Key exclusion criteria (3 listed)
- Atypical parkinsonisms
- PD patients with relevant orthopedic
- Rheumatic and muscular conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isokinetic strength
Time frame: One month
Laboratory measurements of isokinetic strength
1 secondary outcome
Muscle functionality
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Frazzitta, MD principal investigator
Ospedale Generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic strength (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.