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

NCT ID: NCT02369224

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-02-29

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)

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

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

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore R Brown, MD

Role: PRINCIPAL_INVESTIGATOR

MS Center at Evergreen

Locations

MS Center at Evergreen Health

Kirkland, Washington, United States

Countries

United States

Other Identifiers

TRB2014A

Identifier Type: -

Identifier Source: org_study_id