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: Multiple Sclerosis

• Registration Number: NCT02369224
• Lead Sponsor: Brown, Theodore R., M.D., MPH

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-23
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Patients will be tested at two visits separated by 1-21 days	Inter-rater reliability intraclass correlation coefficient (ICC) combined for all observers (two observations per subject) for lower extremity Strength Sum Score (SSS)

Trial Locations

Locations (1)

MS Center at Evergreen Health; 🇺🇸 Kirkland, Washington, United States