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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01749943

Acronym

HHD

Enrollment

Registered

2012-12-17

Start date

2012-07-31

Completion date

2013-07-31

Last updated

2013-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	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.

Countries

United States

Outcome results