Ready, Set, Go!

AlterG Bionic LegDan Lewis, PTDeb Soares OTR/L

----- Meeting Notes (4/10/14 07:29) -----

1AlterG Products2AlterG now offers two unique high-tech mobility solutions for the rehab market. Both products facilitate greater amounts of rehab activities and the ability to progress patients to higher level activities than would otherwise be possible.----- Meeting Notes (4/10/14 07:29) -----DAN2Potential Influence of AlterG TechnologyBurridge, Feb 2009.Participation in greater massed practice, with feedback leads to strength gains.Varying the practice conditions to keep the patient challenged near their current limit of performance leads to greater potential for motor learning.Customizable settings allow the therapy to be progressed for continual challenge to the patient.----- Meeting Notes (4/10/14 07:29) -----DAN3

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AlterG Bionic LegThe Bionic Leg translates patient intention into robotic assistance. It does this through weight sensors under the patients foot, along with motion sensors at the knee. The assistance is entirely customizable by the treating clinician.----- Meeting Notes (4/10/14 07:29) -----DAN4The Bionic Leg - What is it?Robotic leg orthosisRobotic assistance based on patient initiated movementTwo dynamic motorsHigh torque for up and downHigh speed to enable swing phase Foot sensors are miniature load cells that sense downward pressure to activate the legProgrammable for appropriate level of assistance as patient progresses

Again, the key is active patient participation in initiating movement that is required to trigger the assistance from the device. The high-speed motor allows the device to move out of the way when assistance is NOT required. This allows for the maximum participation by the patient. This ability to get out of the way is referred to as transparency in robotic devices and is believed to help drive functional improvements by allowing for greater patient participation.----- Meeting Notes (4/10/14 07:29) -----DAN5Dynamic, As Needed Assistance

Weight shift triggers:Assistance (stand)Resistance (sit)Stabilization (walk)Easily Programmable to Match Patients Functional LevelWeight shift and knee motion trigger assistance with knee extension and resistance to knee flexion. This, along with the physical support of the device act to stabilize the patients weak leg in all standing activities. The amount of assistance and resistance provided are highly customizable, based on the patients needs.----- Meeting Notes (4/10/14 07:29) -----DAN6Leg SpecsLeg weight approx. 8 lbs.Minimum to maximum patient height 5-66Minimum to maximum weight appx 100-300 lbs.Battery life-1-2 hours, requires only 45 min to chargeFoot sensors 4 sizes each side, total of 8 included

----- Meeting Notes (4/10/14 07:29) -----DAN7Clinical Benefits:Confidence for Patients and TherapistsAllows patients to safely do more repetitions of higher level activitiesStrengthens muscles and enables active motor learning Allows therapist to focus on function-not lifting patientImproves functional mobility with carry overPre Gait Activities - Improve stance stability, weight shift, balanceSafely supports patient, protects therapist

----- Meeting Notes (4/10/14 07:29) -----DEB8Clinical BenefitsAnother tool in the toolbox for therapists Allows low mobility patients to perform standing/functional activitiesSomething to integrate into existing therapy to be more effectiveProvides stance stabilityGives patient and therapist a stable base to work fromLike an extra set of hands for the therapistAllows the therapist to better facilitate quality of motion

Patients will usually have instability further up the chain from the knee. I initially hear this from therapists, but by stabilizing at the knee, we now have a stable base for the patient to work from, performing standing functional activities that can strengthen at the hip, pelvis and trunk.----- Meeting Notes (4/10/14 07:29) -----DEB9Maximizes Inputs Needed for Effective Therapy

Corrects Biomechanical MovementIncreases Intensity, EngagementMaximizes RepetitionsImproves Confidence

Effective, Durable Therapy10Ambulation (m/s)Endurance (m)Berg Balance.052323 Initial assessment.1766501 month after end of treatment.133840After 4 weeks, 2 sessions/weekFirst patients: (57 Year old, 8 Years s/p stroke)After - Independent SafetyBefore - Compensatory for Life

Today, 2 years post study: .45 m/sShow 1st and last 5 sec11When I train clinicians, I try to focus on impairments and functional deficits rather than diagnoses. This is to create the broadest filter for inclusion initially and narrow down from there who the device is appropriate for.----- Meeting Notes (4/10/14 07:29) -----DEB12Precautions and ContraindicationsWhat are the contraindications?Unresolved/resolving DVTOpen woundsActive drug-resistant infectionRecent/unstable fracture, ie. any weight-bearing restrictionsAnd the precautions?Osteoporosis/long-term use of osteoporosis medicationsConsider this with all SCI patientsUnstable cardiovascular conditions/unstable for exercisePAD (insufficiency) peripheral arterial diseaseIncontinence (multiple patient use)

13----- Meeting Notes (4/10/14 07:29) -----DEB13Programmable Settings14----- Meeting Notes (4/10/14 07:29) -----DEB14

Gait

Stair ClimbingSit to Stand

Weight ShiftingThe device is used to assist patients in performing more of any standing activity, from early attempts to get patients up from sitting, to facilitating better and more symmetrical LE weight bearing, to improving gait symmetry and endurance. Its also very useful in progressing patients to stair climbing and getting back to reciprocal stair climbing.----- Meeting Notes (4/10/14 07:29) -----DEB15Supporting Principles of Motor LearningWhy Use the Bionic Leg?1616Theories Have EvolvedResearch in motor control/motor learning has more recently begun to make an impact on the practice of rehabilitation.Rehabilitation typically focused on passive facilitation of isolated movements or teaching patients to compensate for lost movement

17Traditional view was that the motor cortex was static, with specific areas of the cortex dedicated to specific areas of the body. We now know this is not the case and that the firing patterns within the cortex are plastic and changeable and that they change based on the activities that are performed.17In a review of rehabilitation approaches after neurological injury, the greatest improvements were seen with high intensity, repetitive, task-specific interventions, regardless of impairment or technique being usedTASK SPECIFC! The tasks practiced must be as close to the real world task as possible. Practicing isolated movements only leads to improved ability to perform those isolated movements. Therefore, rehab activities must be structured to maximize practice of varied and functional tasks. The BL allows for exactly this process greater repetitions of higher-level functional activities.19Use It or Lose ItBionic Leg Facilitates use of involved limb during mobility tasks.

Drives increased engagement and attention of involved side.

Volitional movement required to activate device

Increased (customized) threshold = increased initiated movement of involved limb required to activate device.

20By facilitating active use of the involved limb, we are achieving task specific practice and can then customize the settings to appropriately and progressively challenge the patient. The therapy can be progressed to remain challenging for the patient as mobility improves.20Repetition

The lesson is that there are multiple limiting factors in completing high levels of repetition. Patient weakness and fatigue, therapist fatigue and both patient and therapist safety. We know it requires very high repetitions to learn new tasks, so the BL allows us to safely complete more repetitions than could otherwise be completed.21High RepetitionsIntensive practice means tons of repshundreds a dayCanning C, et al., A randomized controlled trial of the effects of intensive sit-to-stand training after recent traumatic brain injury on sit-to-stand performance, Clinical Rehabilitation, 2003; 17:355-362.24 subjects randomized (11 control/13 experimental)Trained over four weeksTargeted 100 reps of sit to stand and 60 step ups per day; five days a weekVaried chair and step height over the four weeks62% improvement in motor performance (sit to stand) for experimental compared to 18% for control.In addition to their usual rehabilitationProgram subjects in the experimental group participated in 4weeks of intensive training of sit-to-stand and step-up exercises

The control group did no additional sit-to-stand or step-up training.

22Sensory Input/FeedbackFeedback can enhance motor learningSelf correction occurs when user applies feedback to performance enhancementFocuses users attentionFeedback comes in many forms including visual consider videotaping your clients before and after device useVan Vliet P, et al., Extrinsic feedback for motor learning after stroke: What is the evidence?, Disability and Rehab, 2006; 28(13-14): 831-840.Engardt M, et al., Vertical ground reaction force feedback to enhance stroke patients' symmetrical body-weight distribution while rising/ sitting down., Scand J Rehab Med 1993; 25:41-48.Feedback is a key component to motor learning. Patients learn best when they are able to self correct in response to feedback. The device provides sensorimotor feedback, audible feedback and proprioceptive feedback during exercise. These afferent inputs are frequently missing in many neurologic conditions so use of the device give greater CNS input than is received without the BL.23Clinical Studies2424Clinical Evidence: Summary of FindingsUCSF Increased endurance, gait speed, stride lengthWith carryover improvements maintained post therapyColumbia UniversityImprovements in endurance, gait speed, balanceAgain, maintained after the treatment - Carryover plus continued improvementTested 1 month and 3 months post treatmentUniversity of Florida (Publication pending)Improved Antero-Postero Stability, i.e. decreased fall riskEMG phasing improved toward normal or less compensatory25Two published and one pending study completed. Multiple single-patient case studies underway in a constant effort to create treatment examples and protocols.UCSF and Columbia looked at chronic CVA patients notorious for plateauing in therapy and regressing over time. Difficult to change ingrained patterns but patients were able to make gains.2510 meter walk testPre Post+1 month% ChangePatient 1 (5 yrs post).59 m/s.81 m/s.95 m/s61%Patient 2 (1.5 yrs post).29 m/s.43 m/s.45 m/s55%Patient 3 (10 yrs post).83 m/s1.03 m/s1.14 m/s37%6 min walk testPre Post+1 month% ChangePatient 1 (5 yrs post)170 m207 m250 m47%Patient 2 (1.5 yrs post)93 m140 m123 m32%Patient 3 (10 yrs post)271 m300 m285 m5.2%

Outcomes from UCSF StudySignificant gains in therapy were maintained after the therapy was stopped evidence of not just motor performance but motor learning, i.e. carryover.26Clinical ResultsInternational Conference on NeuroRehabAcute carryover in balance scores, stability in stanceThe BL allows the user to involve their weaker leg more than would otherwise be possible...Largest Studies to DateTransfersGaitSignificant improvement in muscle engagement by EMGSymmetry of motion altered towards healthyChanges post-stroke are consistently present and alter EMG towards normal

Looked at more acute CVA patients in a more controlled gait lab that could measure gait symmetry, stability and muscle engagement via EMG.27Shepherd Center TBI Case Study23 y/o female s/p MVAMultiple skull fractures, L temporal SDH, IPH pons, midbrain, R cerebellar peduncle Patellar fracture, left transverse process fracture T1

Patient presented with:severe left hemiplegiapoor spatial awarenessmild left neglectpoor visual acuitymild pushing tendencies

2828Initiated use of Bionic Leg 6 weeks post-admission (1 day after emergence from coma)2-3 times per week for functional gait skills.

29TransfersSit/StandGait1Max A (sit pivot)DependentDependentMod/Max 2-3 (ARJO UE Support)2Min A (sit pivot)Mod ADependent (ARJO < 50ft)Min A x 23Min A (stand pivot)Min AMin A x 2 > 100 ft

4Min A (stand pivot)Min AMin A 1-2 200-300ft (no BL)29Activities1Pre-gait stance control, weight shifts, very limited gait (step-to pattern) Pusher Syndrome behaviors noted

2Stance control, kicking ball with unimpaired LE while maintaining stance on left (20-30 reps), anterior weight shifts in sit/stands for increased symmetrical weight bearing during transitional movements, gait (step-through)

3Continued ball kicks for weight acceptance left LE, lateral weight shifts to left, gait in open environments, stair training

4Gait training without device, *no pushing behaviors noted3030Questions & Answers31