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

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

Detailed Description
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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.

Official Title
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Validation of a Hand-Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EDSS Score 0-3.5<br>21 Subjects Total : 7 with normal to mildly limited walking | |
| EDSS Score 4.0-5.5<br>21 Subjects total: 7 subjects with moderately limited walking ability. | |
| EDSS Score 6.0-7.5<br>21 Subjects total: 7 subjects with severely limited walking ability | |

What is the study measuring?
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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 |