Expired Study
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Kirkland, Washington 98034


Purpose:

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


Study summary:

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)


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


Study is Available At:


Original ID:

TRB2014A


NCT ID:

NCT02369224


Secondary ID:


Study Acronym:

EMST-LE


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Theodore R Brown, MD
Principal Investigator
MS Center at Evergreen

Study Dates

Start Date:January 2015
Completion Date:February 2016
Completion Type:Actual
Primary Completion Date:February 2016
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 31, 2017
First Received Date:February 17, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Inter-rater reliability intraclass correlation coefficient (ICC) combined for all observers (two observations per subject) for lower extremity Strength Sum Score (SSS)

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brown, Theodore R., M.D., MPH
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Biogen

Samples and Retentions

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).
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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