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OpenTrials
Completed

NCT Number: NCT02369224

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MS Center at Evergreen Health

Kirkland, Washington, 98034, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

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

Indiv

Collaborators

  • Biogen

Registry information

Acronym: EMST-LE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2015
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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