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

Multiple Sclerosis Clinical Trial

— HHD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749943
• Other study ID #: US-AVX-11-10213
• Status: Completed
• Phase: N/A
• First received: November 26, 2012
• Last updated: August 20, 2013
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Brown, Theodore R., M.D., MPH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	MS Center at Evergreen Hospital	Kirkland	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Brown, Theodore R., M.D., MPH	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No