otto bock neurostimulation - fes education · otto bock neurostimulation 3 ©otto bock healthcare...

Otto Bock Neurostimulation

1

www.ottobock.com

ActiGait®

Implantable drop foot stimulator

FES Education DayUniversity Hospital, Coventry

25 November 2010

2© Otto Bock HealthCare

Contents

�Company background

�ActiGait®

� Indications

� product description

�Clinical evidence

� Patient videos

� Patient testimonials

�Functional Electrotherapy – STIWELL med4

�Live demonstration


Otto Bock: Who are we?

• Started 1919

• 4218 employees, 40 direct rep, 140 countries

• €30m annually for research and development

Prof. H.G. Näder,

Owner and CEO

Family business in 3rd

generation

Otto Bock Foundation

Otto Bock Science Centre for Medical

Technology, BerlinOtto Bock Academy

Headquarters

Duderstadt, Germany


Otto Bock UK: Who are we?

� Headquarters in Egham, Surrey

� 27 years

� Clinical service, production, sales, education and training

�4 divisions: Neurostimulation, Prosthetics, Orthotics, and

Mobility

Orthotic Service Fabrication,

Birmingham

Special Seating

Leeds

UK HQ

Egham offices


� Upper extremities

� Lower extremities

� Socket Technologies

� Materials

� Osseointegration

� Modular orthoticsystems

� Braces and Support

� Materials

� Continuous Passive Motion

� Rehband Sport

� Manual wheelchairs

� Powered wheelchairs

� Pediatrics

� Seating & positioning

� Premium Products

Orthobionic®

� FES-Therapy

� Neuroimplants(ActiGait)

Bionicmobility®

Prosthetics OrthoticsMobility

SolutionsNeurostimulation

Strategic Business Segments

� QM – Code of Practice

� Financing Solutions

� Service Fabrication

� Planning & Equipping

� Customized Care

� Otto Bock AcademyBusiness

Services

Business

Services

Patient CarePatient Care Otto Bock Competence Centre and Clinical CentreOtto Bock Competence Centre and Clinical Centre

� IT-systems integration

One company taking each step to recovery with our customer One company taking each step to recovery with our customer

What we cover �What we cover �


Patient Flow

Stages

Function

ActiveActive ImplantsImplants

OrthoticsOrthotics

FES / FET

ActiGait®ActiGait®

NeuroStep®NeuroStep®

Walk On®

Neurexa

Line

„STIWELL med4“„STIWELL med4“

MotorMotor RehabilitationRehabilitation afterafter StrokeStroke


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Neurostimulation

www.sbg.ac.at


Neurostimulation

• Functional Electrical Stimulation

FES

ActiGait®

• Functional Electro Therapy

FET

STIWELL med4

www.ottobock.com

ActiGait®

Product Description


ActiGait® implantable drop foot stimulator

External control unit

External antenna

Implanted receiver

Implanted electrode

Heel switch


ActiGait® - history & current status

� 1999: First prototypes implanted in

Denmark (Neurodan, Aalborg)

� 2003: Evaluation trial (15 patients

in 3 rehabilitation centres in

Denmark)

� September 2006: CE marking

� ~50 patients in Europe: Germany,

Netherlands, Denmark, Austria,

Luxemburg

� 2010: UK launch


ActiGait® - general description & indications

� Stroke patients

� Mobile patient where drop foot is the main problem with gait

� To improve gait (speed, endurance, symmetry)

� Aid patient’s subjective perception of independence, safety, and confidence in walking

� Solution for patients unable to use surface FES (for example due to skin reactions or sensitivity)

� Avoids problems of surface electrode positioning

� Easy to use and cosmetic solution


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ActiGait – Indications

� be fully grown-up

� have a single-sided hemiparesis due to a cerebro-vascular accident

� have a passive range of movement of the affected ankle joint of at

least 30 degree

� be able to stand upright with both heels touching the floor while hips

and knees are in neutral position (without the need of an AFO for

stance control)

� have a reduced speed of walking

� be able to walk 20 meters in less than 2 minutes with or without

walking aid but without the help of another person

Patients must


ActiGait – Indications (continued)

have a positive response to surface electrical stimulation of the peroneal nerve – i.e. muscle contraction results in ankle dorsiflexion and improved gait

� Clinical point of view

� Patient point of view

Patients must


ActiGait - Contra indications

� peripheral nerve damage in the affected lower extremity

� severe or uncontrolled diabetes mellitus or other diagnosis with

peripheral nerve involvement

� poor skin condition on the affected lower extremity

� a subcutaneous layer of fat on the thigh of more than 3,5 cm

� poorly controlled epilepsy

� inability to walk 100 m without stopping prior to CVA (with or without a

walking aid, but without the help of another person)

Patients having:


ActiGait - Contra indications (continued)

� other active neuro-implants such as defibrillators and demand pacemakers

� concomitant medical and psychological conditions which would limit the success of the ActiGait® system

� concomitant medical and psychological conditions which would compromise the safety of the patient in connection with the implantation or use of the ActiGait® system

Patients having:


ActiGait - External Components

Control unit

Heel switch

Antenna

Antenna fixation


ActiGait - Control Unit and Antenna

1. Control unit housing

2. Antenna

3. Belt clip

4. Display

5. Power switch

6. ‘Intensity Up’ button

7. ‘Intensity Down’ button

8. Charger socket

9. Charger indicator

10. Clinician interface

� Worn on waist and

held by belt clip

123 g; 120x15x45 mm

� Pulse width control

for all channels jointly

� Data logging

number of steps at

each intensity level

� Rechargeable

battery

8-16 hrs (10,000 steps

or 16 hrs depends on

activity); charge time

3.6 hrs


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ActiGait - Control Unit display

1. Control Unit Battery Level indicator

2. Stimulation Intensity indicator

3. Stimulator Active indicator

4. Heel switch Battery indicator

Low battery Control unit

Low battery Heel switch


ActiGait - Heel switch

1: Housing with battery and radio transmitter

2: Sensor

3: Heel switch sock

� Wireless link to control unit

� Dimensions: 16.7 × 2 cm

� Mass: 22 g (including battery)

� Battery: lithium coin cell type CR2032

� Transmitting range: 2 m

� Life is 4 months @ 8000 steps/day

� Can be used under affected or non-affected side

� Heel switch socks allow use without wearing shoes

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ActiGait - Antenna fixture

� Small hypoallergenic plastic disc

� Attached to the thigh skin surface right above the implanted stimulator

� Clicks onto the inside of the antenna to hold it in place

� Designed to attach to the skin for up to several weeks

� Replace when it loosens enough to be pulled off easily


ActiGait - The Implant

Stimulator body

cuff-electrode Sutures


� 1 silicone cuff electrode placed around the common peroneal nerve proximal to knee joint

� 22 mm long with 12 platinum/iridium contact discs located on the inside.

� 4 channels (interleaved)

� 5 cuff sizes

� Stimulator body implanted in lateral thigh

� Wireless link between antenna coil & stimulator body

� 15 g; 60 x 30 x 6 mm stimulator body; cable length 25 cm

� 10 years lifetime



� 1 silicone cuff electrode placed around the common peroneal nerve proximal to knee joint

� 22 mm long with 12 platinum/iridium contact discs located on the inside.

� 4 channels (interleaved)

� 5 cuff sizes

� Stimulator body implanted in lateral thigh

� Wireless link between antenna coil & stimulator body

� 15 g; 60 x 30 x 6 mm stimulator body; cable length 25 cm

� 10 years lifetime



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ActiGait - Surgery

A B C


ActiGait - Technical Data

Fixed Settings:

• Pulse shape: Asymmetric bipolar; charge

balanced - exponential discharge (capacitive) for passive phase

• Current amplitude: 1.2 mA

Adjustable Settings:

• Pulse duration: 0 – 300 µs

• Stimulation frequency: 5 – 50 Hz

• Number of active channels: 1 – 4 channels

• Stimulation profile according to heel lift and heel strike

• Position of heel switch on affected or non-affected leg.


ActiGait - Activation and device setup

2-3 weeks after surgery;

depends on wound healing.


ActiGait - Clinical Station software

� Programming stimulator settings

� Patient database; store all patient settings, such as demographic data, previous sessions settings etc.

� Flexible setting of FES timing and parameters


� Flexible setting of FES timing parameters

� Delay 0 – 2 s

� Extension 0 – 2 s

� Ramp up 0 – 2 s

� Ramp down 0 – 2 s

� Intensity can be controlled to increase at heel contact above swing phase stimulation level and before ramp down

ActiGait - Clinical Station Software


� Flexible setting of FES parameters

� Number of adjustment steps for patient control of intensity

� Stimulation frequency 5 – 50 Hz

� Heel switch can be used under affected or non-affected side

� Exercise mode (software control on intensity, on/off duration)



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� software control for the range & step value change for each channel individually:

� Maximum stimulation

� Minimum stimulation

� Maximum stimulation set by patient

� Normal stimulation

� Minimum stimulation set by patient

� Any combination of the 4 channels can be activated

� 0 – 300 microsec in steps of 0.3 microsec



ActiGait implantable drop foot stimulator

www.ottobock.com

ActiGait®

Clinical evidence


Functional Electrical Stimulation for drop foot

Liberson et al. 1961


• Objectives:

• To evaluate safety, performance, efficacy and subject satisfaction of the ActiGait® dropfoot stimulator system

• Study design:

• Prospective , non-randomised, open label multicenter study, repeated measures over a period of 90 days, 15 months follow-up

• Participants:

• 15 hemiplegic subjects with drop foot, at least 6 months after stroke

• Settings:

• Three Danish Clinical Centres

Danish ActiGait® Clinical Trial




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• Efficacy:

• Statistically significant increase in walking distance and maximal gait speed

• 14 % increase in distance walked in 4 minutes

• 20 % increase in gait speed

Max self-selected gait

speed (m/s)

Distance walked in 4 min

(m)

20%��0,0080.10

14%��0,02816,23

PMean difference

•paired samples t-test, 15 month – baseline (n=13)

Burridge et al.: J. Rehab Medicine 2007, 39;212-218


38© Otto Bock HealthCareActiGait® Course

Walking distance and max. speed

Baseline 15 months

(n = 13) NS NS S

Distance

walked (m)

mean (SD)

min to max

126.6 (41.9)

60 to 184

131.4 (51.5)

43 to 203

142.9 (49.3)

59 to 199

Max speed

(m/s)

mean (SD)

min to max

0.55 (0.18)

0.25 to 0.74

0.58 (0.23)

0.18 to 0.87

0.66 (0.22)

0.25 to 0.87

Burridge et al.: J. Rehab Medicine 2007, 39;212-218

van de Port et al.: J. Rehab Medicine 2008, 40;23-27

Support transition from non- or limited community walker

to confident community ambulation


ActiGait® Clinical Trial – Patient perceptions

Safety

Confidence

Independence

When I use ActiGait® I am

less likely to trip or fall

more confident in walking

more independent

Strongly agree I agree I disagree Strongly disagree


Subject Satisfaction Questionnaire

How often do you use the system?


Subject Satisfaction Questionnaire cont.

When I use ActiGait® I feel more confident in walking



I prefer to use the ActiGait® to a splint


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Do you need help to put the ActiGait® on?

www.ottobock.com

ActiGait®

Patient videos


• Male aged 55

• CVA 2003

• Right side effected

• Weak activity m. tibialis anterior, none activity m. peronaeus

• Ashworth scale

hamstring muscle group 0

quadriceps muscle group 0

calf muscle group 1

Patient K.P.


No stimulation ActiGait

Patient videos – Patient K.P.

• conventional therapy was not successful, the splint generated spasticity in the toes

• “since using the system I have less back pain”

• K.P. is surprised that he is not any longer stumbling when the system is off


Patient videos - TM

Without stimulation With stimulation

ActiGait OFF ActiGait ON


Patient testimonials

� ‘It has become easier to go shopping and handle daily living’

� ‘I can change shoes faster, walk without shoes and wear sandals’

� ‘My legs are warmer; now I seldom get cramps’

� ‘I don’t care how I walk, but now I can sleep during the night

because my cramps have almost gone’

� ‘I am more motivated for going out – I have been travelling’

� ‘My nose is not pointing downwards any longer’


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Neurostimulation

• Functional Electro Therapy

FET

STIWELL med4

• Functional Electrical Stimulation

FES

ActiGait®


STIWELL med4 – functional electrotherapy

• 4 stimulation channels

• 2 EMG measurement channels

• EMG-triggered stimulation

• Programmable

• Biofeedback

• Memory for storing treatment data

• Training of coordination, inhibition, myosymmetry

• muscle relaxation

• PC games for biofeedback

• Denervated muscle stimulation


STIWELL med4 programs

• Muscle Strenghthening

• Denervated Muscles

• Feedback Programs

• Feedback Display Games

• Feedback PC-Games

• Pain Therapy TENS

• Urology

• Functional Programs

• Sports

• Mid-Frequency

• Individual Programs


STIWELL med4

• Muscle strengthening

• Maintaining or improving joint mobility

• Functional task-oriented training

• Increasing blood supply

• Muscle relaxation

• Pain therapy (TENS)

• Re-establishment of movement patterns

With the following indications:� Disease or injury of the CNS/spinal cord (stroke, SCI, incomplete paraplegia)

� Peripheral nerve lesions capable of regeneration

� Neuro-orthopedic functional disorders

� And for additional muscle training and regeneration in sports

Intended Use & Indications

www.ottobock.com© Otto Bock HealthCare

Live demonstration session

www.ottobock.com© Otto Bock HealthCare

Thank you for listening - Any questions?Salim Ghoussayni PhDBusiness Development Manager – Neurostimulation

32, Parsonage Road, Englefield Green, Egham, Surrey. TW20 0LD+44 (0) 1784 744 900 +44 (0) 7969 586550

[email protected]

otto bock neurostimulation - fes education · otto bock neurostimulation 3 ©otto bock healthcare...

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