NeuroFlexor brochure 090312 - Aggero MedTech ·...

NeuroFlexorTM Brochure Aggero Medtech AB 9 March 2012

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Moving spasticity measurement forward

Background and rationale for NeuroFlexor

Spasticity is a type of muscle stiffness often occurring after brain injury related to for

example stroke, trauma, multiple sclerosis and cerebral palsy. Spasticity limits movement

and functional activities (dressing, feeding walking, etc, can cause pain and reduce quality of

life. Many therapies and pharmaceutical interventions are used to reduce spasticity such as

physiotherapy, orthoses and injection of botulinum toxin into muscle). However, treatments

are costly and often inefficient. One problem is that the treatments are not properly

targeted to the underlying causes of spasticity. Spasticity is composed of both muscle

stiffness and neural over activity (increased stretch reflex). Today in the clinic spasticity is

measured manually using a subjective scale. Treatment today cannot be properly targeted

since the clinical measures used do not allow for separate measurement of these spasticity

components. Another problem with subjective scales for measurement of spasticity is the


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lack of accuracy and reliability. Spasticity measurement is therefore a major problem in

neurology and rehabilitation today.

Aggero Medtech AB is a Swedish medical technology company that develops, manufactures

and markets innovative diagnostic and training instruments for research and clinical work.

Our ambition is to provide a full range of clinically validated and easy-‐to use tools for

quantitative measurement and training in the field of neurorehabilitation. At present, we

offer a new solution to accurate clinical measurement of spasticity (NeuroFlexor). The

NeuroFlexor device offers the unique possibility to objectively measure the different

components of spasticity in a highly reliable manner. The device measures the resistance

when the limb is moved passively (subject is relaxed). Using a validated biomechanical

model the neural (reflex) and muscle (stiffness) components of spasticity are estimated. The

NeuroFlexor measurement gives information on the individual’s unique spasticity profile

and is thus useful for optimizing treatment. The method is reliable making it suitable for

patient follow-‐ups and evaluation of treatments.

NeuroFlexor: Main features and advantages

Innovative combination of technology and biomechanical know-‐how

The NeuroFlexor is composed of a servo motor and force sensor coupled to a portable

computer. Passive limb displacements are produced at controlled velocities. Resistance is

measured accurately using a force sensor. The resulting resistance trace is then analyzed

according to a validated biomechanical model. The biomechanical model describes how

various mechanical components in the stretched muscle and the resulting neural activation

by the stretch reflex contribute to the resistance produced during stretching. This new

model for estimation of spasticity components has been validated and the findings have

been published in the journal Neurorehabilitation Neural Repair (2011).

Measurements are objective and reliable

The NeuroFlexor provides objective data from a force sensor. This eliminates the subjective

step of rating how the spasticity feels (the most common clinical way to measure spasticity


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today). A recent study also shows that the NeuroFlexor measurements are highly reliable,

i.e., measurements performed by different clinicians or on different times are very similar

(see NeuroFlexor: Scientific results and clinical benefits).

NeuroFlexor is easy to use in the clinic

NeuroFlexor has been developed to be suitable for clinical use. The device is compact and

easy to use being suitable for bedside measurements as well as research protocols.

Controlling the device by use of the developed interface on the computer is simple and

interactive. Illustration of measurement results on the computer screen is informative for

both clinician and patient.

NeuroFlexor user interface is

designed to be easy to use for the

clinician. Movement settings can be

saved and reloaded. This means that

similar measurements can be

performed on different days

increasing reliability of

measurements.


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NeuroFlexor results are detailed and informative. Above is an example of results in a a stroke patient with

spasticity. Bright red curves on top represent force traces produced with a fast velocity (240°/s) stretch. Bright

red curves below represent force traces produced with a slow velocity (5°/s) stretch. Dark red curves show

force profile without hand (run empty). The software estimates the Neural, Elastic and Viscosity components

contributing to the resistance according to a validated biomechanical model.

NeuroFlexor provides useful data for research

The NeuroFlexor method offers many advantages for clinical research on spasticity.

NeuroFlexor is the only device available today which allows measurement of both neural

and mechanical contributions to passive movement resistance in spastic muscles. With

NeuroFlexor spasticity patient-‐specific spasticity profiles can be obtained allowing a more

specific approach when evaluating effect of anti-‐spasticity treatments. Good reliability of

measurements also makes NeuroFlexor suitable for detection of treatment induced

benefits.


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NeuroFlexor and patient satisfaction

Patients are very content to have their spastic muscle measured using the NeuroFlexor.

Patients express that they are very happy that there now is a method that allows the

clinicians to measure their spasticity correctly and accurately. Patients are also very

interested in seeing their own spasticity profile (reflex and mechanical contributions).

Differences occurring after anti-‐spasticity treatment can be visualized and are of major

interest to patients.

NeuroFlexor: Scientific results and clinical benefits Validation of model

In a study published in Neurorehabilitation Neural Repair (2011) 31 chronic hemiparetic

stroke patients with hand spasticity were measured using the same biomechanical model as

implemented in NeuroFlexor. The findings support the validity of the biomechanical model.

This study scientifically shows that muscle and neural spasticity components can be

measured using the NeuroFlexor method.

Spasticity components before and during

ischemic nerve block in five stroke patients.

The neural component (NC) was abolished or

reduced drastically after the ischemic nerve

block (T0=before nerve block; T25=with

effective nerve block). The mechanical

components (elasticity, E and viscosity, V)

were not affected by the nerve block.

Reliability

Preliminary findings from an ongoing study in 32 chronic stroke patients shows that

measurements with NeuroFlexor have high intra-‐ and interrater reliability.


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The results suggest that measurements with NeuroFlexor have good reliability. This is

important for the clinician wishing to follow-‐up how the spasticity profile changes in

response to treatment.

Reliability of neural component measurements. On left, comparison of two separate measurements by one

rater. On right, comparison of measurements from two raters.

NeuroFlexor: scientific publications, presentations and awards

Publications

Validation of a new biomechanical model to measure muscle tone in spastic muscles.

Lindberg P, Gäverth J, Islam M, Fagergren A, Borg J, Forssberg H. Neurorehabilitation Neural

Repair. 2011;25(7):617-‐625.

Conference presentations

Validity and reliability of a biomechanical method for quantification of "spasticity" in chronic

stroke patients. Gäverth J, Islam M, Fagergren A, Sandgren M, Borg J, Eliasson A-‐C, Forssberg

H, Lindberg P. Scientific poster presented at World Phyical Therapy Conference, Amsterdam,

June 2011

Reliability of a new biomechanical method for the estimation of neural and non-‐neural

contributions to spasticity. Gäverth J, Sandgren M, Lindberg P, Eliasson AC. Scientific poster

presented at European Neurological Society Conference, Lisbon, Portugal, May 2011


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Validation of a biomechanical model for quantification of “spasticity” in chronic stroke

patients. Gäverth J, Lindberg P, Islam M, Fagergren A, Borg J, Forssberg H. Scientific poster

presented at World Neurorehabilitation Conference, Vienna, Austria, March 2010

Prizes and awards

The NeuroFlexor invention was awarded the regional Stockholm 2009 SKAPA-‐Prize. The

SKAPA Prize is awarded to inventors in memory of Alfred Nobel. The award is designed to

incentivise the commercialisation of technological innovation and creativity.

Scientific Poster prize, World Neurorehabilitation Conference, Vienna, Austria (2010)


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Partners

The development of NeuroFlexor has been supported by Swedish universities, research and

innovation agencies.

Contact details

Aggero Medtech AB

MT, Danderyds Sjukhus

182 88 Danderyd

Stockholm, Sweden.

www.aggeromedtech.com

Email: [email protected]

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