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

Completed

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT02369224

Run by

Brown, Theodore R., M.D., MPH

People needed

27

Starts

2015-01-01

Expected to finish

2016-02-01

Last updated by the study team

2017-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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