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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01749943
• Lead Sponsor: Brown, Theodore R., M.D., MPH

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of HHD	Outcome measures will be assessed once we have captured all data points for all 21 subjects.	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.; To establish a standardized strength testing procedure for key lower limb muscle groups using a HHD for research and clinical purposes in Multiple Sclerosis.

Secondary Outcome Measures

Name	Time	Method
Validation of a Hand-held dynamometer for assessment of lower limb muscle strength.	outcome measures will be assessed once we have captured all data points for all 21 subjects	to establish a standardized strength testing procedure for key lower limb muscle groups using a Hand-held dynamometer for research and clinical purposes in Multiple Sclerosis.

Trial Locations

Locations (1)

MS Center at Evergreen Hospital; 🇺🇸 Kirkland, Washington, United States