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

NCT02369224 | Completed

• 1 other identifier: TRB2014A
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Outcome Measures

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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who may qualify for this study will be identified in the context of clinical care at the participating sites. They may also be contacted through approved research flyers. Eligible patients may receive a copy of the informed consent form at the time of their clinic visit. Recruitment will also occur through local promotional opportunities (doctor's programs, patient education programs).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown, Theodore R., M.D., MPH: lead
• Biogen: collaborator

Study Sites (1)

MS Center at Evergreen Health

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Theodore R Brown, MD

  MS Center at Evergreen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 23, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)