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

Study Overview
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Brief Summary
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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

Detailed Description
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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)

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

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |