Validation of Hand Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis (HHD)

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

Status

Completed

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Industry

Identifiers

NCT01749943

US-AVX-11-10213

Details and patient eligibility

About

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

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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