Multicenter Validation of The Evergreen Myometric Strength Test for Lower Extremities (EMST-LE) in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics (EMST-LE)

A Cross- Sectional study; To assess the intra-rater and inter-rater reliability of a hand-held dynamometer (HHD) in the assessment of lower extremity strength in patients with multiple sclerosis

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

Detailed Description

Patients will be tested at two visits separated by 1-21 days. At each visit, the patients would undergo bilateral lower extremity strength assessment by two physical therapists, independently and in the same order. Testing would include: hip flexion, knee extension, knee flexion, ankle dorsiflexion Testing performed with 1) HHD (three trials recording maximum voluntary force) and 2) manual muscle testing (MMT), British Medical Research Council grade 0-5)

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • MS Center at Evergreen Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who may qualify for this study will be identified in the context of clinical care at the participating sites. They may also be contacted through approved research flyers. Eligible patients may receive a copy of the informed consent form at the time of their clinic visit. Recruitment will also occur through local promotional opportunities (doctor's programs, patient education programs).

Description

Inclusion Criteria:

• Stable patients with clinically definite MS, aged ≥18, EDSS of 0-7.5
• Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 30 days prior to screening.
• EDSS as described above

Exclusion Criteria:

Contraindications to Strength testing:

• Inflammatory myopathy
• Endocarditis, pericarditis or other unstable heart disease
• Cardiac surgery or myocardial infarction in the last 3 months
• Decompensated congestive heart failure
• Severe aortic stenosis
• Severe pulmonary hypertension
• Pulmonary embolus or infarction in the last 6 months
• Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure >170, or systolic blood pressure > 105)
• Marfan's syndrome
• Pacemaker or cardiac defibrillator
• Concomitant neurodegenerative neurological disease, such as ALS or Parkinson Disease or hemiplegic stroke
• Females who are pregnant
• Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
• Anticipated treatment with Novantrone (mitoxantrone) or cancer chemotherapy or surgical procedure during the study period
• Painful orthopedic condition affecting the lower extremities
• Any other serious and/or unstable medical condition

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the intra-rater and inter-rater reliability of a hand-held dynamometer (HHD) in the assessment of lower extremity strength in patients with multiple sclerosis	Inter-rater reliability intraclass correlation coefficient (ICC) combined for all observers (two observations per subject) for lower extremity Strength Sum Score (SSS)	Patients will be tested at two visits separated by 1-21 days

Collaborators and Investigators

• Sponsor: Brown, Theodore R., M.D., MPH
• Collaborators: Biogen
• Investigators: Principal Investigator: Theodore R Brown, MD, MS Center at Evergreen

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (ESTIMATE): February 23, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• 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: TRB2014A