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

NCT01749943 | Completed

• 1 other identifier: US-AVX-11-10213
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown, Theodore R., M.D., MPH: lead
• Biogen: collaborator

Study Sites (1)

MS Center at Evergreen Hospital

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Theodore R Brown, MD

  MS Center at Evergreen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

US (1)