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

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)

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