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

Multiple Sclerosis Clinical Trial

— EMST-LE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369224
• Other study ID #: TRB2014A
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: January 31, 2017
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2017
• Source: Brown, Theodore R., M.D., MPH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	MS Center at Evergreen Health	Kirkland	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Brown, Theodore R., M.D., MPH	Biogen

Country where clinical trial is conducted

United States, 

Outcome

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