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Lido Workset Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Agius, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00710645
First received: July 2, 2008
Last updated: November 20, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710645

Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
Mark Agius, MD
Investigators
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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014