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

This study has been completed.
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: August 20, 2013
Last verified: August 2013

November 26, 2012
August 20, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
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.

Assessment of HHD [ Time Frame: participants will be followed up to 21 days ] [ 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 MS>

Complete list of historical versions of study NCT01749943 on ClinicalTrials.gov Archive Site
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.
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Validation of Hand Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis
Validation of a Hand-Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics

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

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Probability Sample

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.

Multiple Sclerosis
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01749943
US-AVX-11-10213
No
Brown, Theodore R., M.D., MPH
Brown, Theodore R., M.D., MPH
Biogen Idec
Principal Investigator: Theodore R Brown, MD MS Center at Evergreen Hospital
Brown, Theodore R., M.D., MPH
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP