Multicenter Validation of The Evergreen Myometric Strength Test for Lower Extremities (EMST-LE) in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Brown, Theodore R., M.D., MPH
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Time Frame: 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)