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Completed

NCT Number: NCT01749943

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MS Center at Evergreen Hospital

Kirkland, Washington, 98034, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Validation of a Hand-held dynamometer for assessment of lower limb muscle strength.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Indiv

Collaborators

  • Biogen

Registry information

Official study title

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

Acronym: HHD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Aug 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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