Lido Workset Study

Assessment of Spasticity in MS Patients Using a Lido Workset

This is a single-site, pilot study. In this study, 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 device arm. 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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Lido Workset

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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be men and women diagnosed with Multiple Sclerosis who have some degree of spasticity in the knee or wrist. They must be at least 18 years of age. This study will also enroll healthy controls who are able to give consent and who are at least 18 years of age. Subjects will be recruited from the community and from the PI's clinic population.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess measure of spasticity	3 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Mark Agius, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 2, 2008
• First Submitted That Met QC Criteria: July 2, 2008
• First Posted (Estimate): July 4, 2008

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Spasticity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 200310977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO