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

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • MS Center at Evergreen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of HHD	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.	Outcome measures will be assessed once we have captured all data points for all 21 subjects.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of a Hand-held dynamometer for assessment of lower limb muscle strength.	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.	outcome measures will be assessed once we have captured all data points for all 21 subjects

Collaborators and Investigators

• Sponsor: Brown, Theodore R., M.D., MPH
• Collaborators: Biogen
• Investigators: Principal Investigator: Theodore R Brown, MD, MS Center at Evergreen Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 26, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): August 22, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: US-AVX-11-10213