Clinical trial NCT01749943: Validation of Hand Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis
Official title: Validation of a Hand-Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Brown, Theodore R., M.D., MPH
Sponsor class: INDIV
Collaborators: name: Biogen
First posted: 2012-12-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stable patients with clinically definite Multiple Sclerosis, aged 18 over, no Multiple Sclerosis exacerbation or change in disease modifying therapy for 30 days prior to screening. Subjects will fall into 1 of 3 EDSS catagories: 0-3.5; 4.0-5.5; 6.0-7.5.

Brief summary: Evaluate a method of testing the strength of five key lower limb muscle groups using a hand-held strength gauge (dynamometer).

Detailed description: Purpose of this study is to assess the intra-rater and inter-rater reliability of a hand-held dynamometer (HHD) in the assessment of lower limb strength in patients with Multiple Sclerosis.

Also to establish a standardized strength testing procedure for key lower limb muscle groups using a HHD fo research and clinical purposes in Multiple Sclerosis.

Eligibility criteria: Inclusion Criteria:

* Stable patients with clinically definite Multiple Sclerosis
* No Multiple Sclerosis exacerbation 30 days prior to screening
* No change in disease modifying therapy for 30 day prior to screening

Exclusion Criteria:

* Inflammatory myopathy
* Endocarditis, pericarditis o rother 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
* Concomitant neurodegenerative neurological disease such as Amyotrophic Lateral Sclerosis (ALS) Parkinsons or hemiplegic stroke
* females who are pregnant
* Cognitive deficits that would interfere with the subjects's ability to give informed consent or preform study testing
* Painful orthopedic condition affecting the lower limbs
* Any other serious and/or unstable medical condition

Primary outcomes:
measure: Assessment of HHD
timeFrame: Outcome measures will be assessed once we have captured all data points for all 21 subjects.
Secondary outcomes:
measure: Validation of a Hand-held dynamometer for assessment of lower limb muscle strength.
timeFrame: outcome measures will be assessed once we have captured all data points for all 21 subjects
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: MS Center at Evergreen Hospital
state: Washington
Study officials:
affiliation: MS Center at Evergreen Hospital
name: Theodore R Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: