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

This study is currently recruiting participants.
Verified December 2012 by Brown, Theodore R., M.D., MPH
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier:
NCT01749943
First received: November 26, 2012
Last updated: February 4, 2013
Last verified: December 2012
History of Changes
  Purpose

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


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brown, Theodore R., M.D., MPH:

Primary Outcome Measures:
  • Assessment of HHD [ Time Frame: Outcome measures will be assessed once we have captured all data points for all 21 subjects. ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 21
Study Start Date: July 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
EDSS Score 0-3.5
21 Subjects Total : 7 with normal to mildly limited walking
EDSS Score 4.0-5.5
21 Subjects total: 7 subjects with moderately limited walking ability.
EDSS Score 6.0-7.5
21 Subjects total: 7 subjects with severely limited walking ability

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749943

Contacts
Contact: Carey Gonzales, Coordinator 425-899-5374 clgonzales@evergreenhealth.com

Locations
United States, Washington
MS Center at Evergreen Hospital Recruiting
Kirkland, Washington, United States, 98034
Contact: Carey Gonzales, Coordinator     425-899-5374     clgonzales@evergreenhealth.com    
Principal Investigator: Ted Brown, MD            
Sub-Investigator: Virginia Simnad, MD            
Sponsors and Collaborators
Brown, Theodore R., M.D., MPH
Biogen Idec
Investigators
Principal Investigator: Theodore R Brown, MD MS Center at Evergreen Hospital
  More Information

No publications provided

Responsible Party: Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier: NCT01749943     History of Changes
Other Study ID Numbers: US-AVX-11-10213
Study First Received: November 26, 2012
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013