Lido Workset Study
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Purpose
We hope to learn if the Lido Workset is a sensitive measure of limb spasticity in patients with Multiple Sclerosis (MS). The Lido Workset is a FDA approved, non-invasive device which has been used to assess motor function and spasticity. The testing will take approximately 25 minutes. Subjects will lie down on a table and have a leg attached to the Lido Workset. The Lido Workset will move the leg back and forth many times at different speeds. The Lido Workset will also analyze resistance to passive (while subject is not moving or resisting movement) movement of the wrist and knee.
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis |
Device: Lido Workset |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Assessment of Spasticity in MS Patients Using a Lido Workset |
- Assess measure of spasticity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | April 2003 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
50 subjects with multiple sclerosis will be tested one time on the Lido Workset. The test will take approximately 25 minutes. The servo-controlled torque motor system will analyze resistance to passive movement of the knee. This testing may be repeated for a group of randomly selected subjects. Each subject will be given the option to participate in the extended testing or to decline. The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session. The total length of time for participation in this study may be up to three weeks.
|
Device: Lido Workset
The intervention will consist of spasticity testing on the Lido Workset device. The servo-controlled torque motor system will analyze resistance to passive movement of the knee.
|
|
Sham Comparator: Arm II
25 normal subjects will be tested on the Lido workset. The testing will be performed one time for each patient and will take approximately 25 minutes. The servo-controlled torque motor system will analyze resistance to passive movement of the knee. This testing may be repeated for a group of randomly selected control subjects. Each subject will be given the option to participate in the extended testing or to decline. The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session. The total length of time for participation in this study may be up to three weeks.
|
Device: Lido Workset
The intervention will consist of spasticity testing on the Lido Workset device. The servo-controlled torque motor system will analyze resistance to passive movement of the knee.
|
Detailed Description:
The information gathered from testing individuals with spasticity due to multiple sclerosis with the Lido Workset has been important in making adjustments to the Lido Workset to show a greater degree of sensitivity in assessing varying degrees of spasticity.
Healthy control subjects will be used to compare the spasticity data of multiple sclerosis subjects with subjects with normal muscle tone to determine the sensitivity of the Lido measurements.
The testing will be performed one time for each patient and will take approximately 25 minutes. The servo-controlled torque motor system will analyze resistance to passive movement of the knee. This testing may be repeated for a group of randomly selected subjects from both the MS subjects and control subjects. The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session. The total length of time for participation in this study may be up to three weeks. This additional testing will be done in order to compare the results with the Lido data obtained at similar timepoints from the subjects enrolled in the Cannabis for Spasticity in MS study. Each subject will be given the option to participate in the extended testing or to decline.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Must have a diagnosis of multiple sclerosis and
- Must have some degree of spasticity or
- Must be a healthy control subject
- Ability to give informed consent
Exclusion Criteria:
- Patients with any life-threatening or unstable clinically significant disease
- Patients with other causes of reduced range of motion of the knee or wrist
Contacts and Locations| United States, California | |
| University of California, Davis | |
| Sacramento, California, United States, 95817 | |
| Principal Investigator: | Mark Agius, MD | University of California, Davis |
More Information
No publications provided
| Responsible Party: | Mark Agius, MD, Principal Investigator, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00710645 History of Changes |
| Other Study ID Numbers: | 200310977 |
| Study First Received: | July 2, 2008 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
Multiple Sclerosis Spasticity |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013