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Clinical Trials/NCT01749943
NCT01749943
Completed
Not Applicable

Validation of a Hand-Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics

Brown, Theodore R., M.D., MPH1 site in 1 country21 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Brown, Theodore R., M.D., MPH
Enrollment
21
Locations
1
Primary Endpoint
Assessment of HHD
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Brown, Theodore R., M.D., MPH
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Assessment of HHD

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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