Lido Workset Study

NCT00710645 | Completed

• 1 other identifier: 200310977
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Spasticity

Outcome Measures

Primary Outcomes (1)

• Assess measure of spasticity

  3 weeks

Study Arms (2)

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

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

Interventions

Lido Workset DEVICE

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 I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with any life-threatening or unstable clinically significant disease
• Patients with other causes of reduced range of motion of the knee or wrist

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Agius, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: April 1, 2003
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)