presentation 225 b linda cates use of bioness l300 functional electrical stimulation orthoses in...
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Use of Bioness L300 Functional
Electrical Stimulation Orthoses
in the Management of
a patient with PLS
Linda Cates, MS, PT, NCS
Duke ALS Team
Duke University Health System
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Primary Lateral SclerosisAffects neurons in cerebral cortex/corticospinal tracts
Results in upper motor neuron signs
Spasticity, hyperreflexia, clonus
Usually affects Legs followed by trunk, arms/hands and later bulbar regions
Symptoms
Muscle stiffness & spasticity
Weakness
Clumsiness/slowness of movement
Balance problems
Speech and swallowing (www.ninds.nih.gov)
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Primary Lateral Sclerosis
Males > females affected
Onset: 40 60 years of age
Slow progression
Not believed to be hereditary
Diagnosis of exclusion
ALS
Hereditary spastic paraparesis
Usually diagnosed over 3-4 years
(www.ninds.nih.gov)
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Patient: JT symptoms onset: ~ 1999 (~ age 38)
Family history of CMT, LE spasticity
Initial symptom: pseudobulbar affect: crying:
~ 2000: reduced lower extremity limb clearance
10/2002 10/2007: followed by Duke Neurology: probable dx: Hereditary Spastic Paraparesis (HSP)
Progression of LE stiffness/gait changes/falls
2002 Fall: fracture of right radial head s/p ORIF
2003: slurring of speech/muscle spasms at night
2005/2006: 2 falls each with rib fractures
2007: progression of speech difficulties, falls, muscle spasms
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Followed in Duke ALS Clinic: 1/2009 -> Present2009: significant pseudobulbar affect, UMN in bulbar,
cervical and lumbosacral segments, significant dysarthria, falls.
Family history: Genetic testing normal
Dx: probable HSP but PLS not ruled out
11/2011: on Disability, Qualified for BIPAP: FVC 68% MIP -40
Underwent additional genetic testing for HSP: negative
11/2013: Diagnosis changed to PLS
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Medical Intervention ~2003: Valium (spasticity)
2004: Valium & Baclofen (spasticity)
2005: Valium (spasticity)
1/2009: Amitriptyline /discussion of baclofen pump
Pseudobulbar affect / spasticity (respectively)
11/2009: Keppra (muscle cramps)
7/2011: Amitriptyline Nuedexta (pseudobulbar affect)
11/2011: Valium Klonopin (spasticity)
10/2012: Baclofen pump implanted (spasticity)
2012 present: Baclofen Pump
Improved speech, overtime not as effective for Lower extremities
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Physical Therapy PresentationStiff legged gait with poor limb clearance in swing right > left. Increased lateral sway
Excessive LE extensor tone/spasticity
Weak hip flexors, extensors and abductors (overtime: 2+/5)
Falls:
Rib fractures 2005, 2006
elbow fx 2002
AC joint injury
CMC ligament tear left hand 2009
evidence of C5-C6 compression fx on MRI following a fall
Continued frequency of falls:at times 1 x / week / 2013 10 falls reported in past year
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Orthotic intervention/assistive
device recommendations
Posterior leaf (flexible) braces
LE extensor tone/spasticity
Limb clearance in swing
Assistive devices:
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Stretches
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Warm water aquatic therapy
Use of recumbent bike
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Bioness L300 Functional Electrical Stimulation
Orthoses (NESS L300 Foot System)
wireless, software driven system designed
for drop foot following an UMN injury or
disease
Provides low level electrical stimulation
to the common peroneal nerve
The wireless Intelli-Sense Gait sensor
detects “heel on” and “heel off”
positions
communicates with the microprocessor
to adjust stimulation for level, uneven
terrain and changes in elevation
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Result was Improved Limb Clearance in
Swing Phase of Gait. How did it work?
Breaking up influence of extensor tone throughout limbs by
providing electrically stimulated dorsiflexion at appropriate
parts of gait cycle
Terminal stance “heel off” to initial contact “heel on”
Allows hip flexors to fire and knees to passively flex with
less resistance due to the reduction in overall LE extensor
tone
(Bioness specific) In stance: Unit can also be programmed to
stimulate anterior tibialis to provide tibial translation and
reduce any knee recurvatum
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JT without bioness
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JT walking with Bioness: Anterior view
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JT walking with Bioness: Lateral view
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JT Bioness posterior view
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Functional Outcome Measures
Gait Velocity
Without Bioness: 0.73m/sec
(0.6-> 0.8 m/sec = household ambulation)
With Bioness: 1.0m/sec
(0.8 -> 1.0 m/sec = limited community
ambulator)
1.1 m/second = norm for age.
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Functional Outcome Measure
Timed Up and Go (TUG)
Without Bioness: 22.51 seconds
With Bioness: 14.01 seconds
<12 seconds = WNLs
>13.5 seconds = increased risk of falls
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Functional Outcome Measure
6 minute walk testWithout Bioness: 924 feet
With Bioness: 1223 feet, 1234 feet
(on 2 different days)
> 1000 feet = community ambulator
Patient was age 52 at time of test
Norm for person 60-69 years = 1876 feet.
✔ 300 feet better with devices!!! More Efficient.
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Letter of Medical Necessity
Justification for Bioness L300Well documented history
Including falls / injuries
Medical management (medicines, baclofen
pump, etc)
Physical therapy interventions (stretches,
exercise, traditional braces, assistive devices)
History of a compliant patient
Functional Outcome Measures with meaningful
change
Information about Bioness device including FDA
approval and Mechanism of how it helps patient
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LMN Alone was not enough!
It Takes a Team
Patient who was willing to be his own
advocate
Go between Insurance company and
Equipment company/Bioness
Neurologist willing to speak to medical
doctor on Insurance board
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Take Home Message
Bilateral Bioness L300 devices were effective in reducing spasticity during ambulation in a person with PLS.
Improved quality of life and function
Reduced risk of falls
Remaining issues
Expensive devices
Limited Insurance Coverage
Limited trials in this population