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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02369224

Acronym

EMST-LE

Enrollment

Registered

2015-02-23

Start date

2015-01-31

Completion date

2016-02-29

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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)

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results