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Orthologix Clinical Update

Featured Product

C-BRACE

The C-Brace is the world’s first mechatronic stance and swing phase control orthosis (SSCO®) system, which controls both the stance and swing phase with microprocessor sensor technology. The functionality of conventional paralysis orthoses is limited to releasing and locking the knee joint. However, the C-Brace supports the user during the entire gait cycle and adapts to everyday situations in real-time.

The C-Brace consists of individually fabricated thigh, calf, and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This lets the C-Brace detect the user’s current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.

The sensors in the knee joint are constantly evaluating (100 times per second) which movement the user is currently performing and how quickly. This information is passed onto the microprocessor in the C-Brace, which regulates the required support.

Stepping Down and Rolling Over

As with a natural gait, the knee is not fully extended when stepping down with the heel. The orthosis damping results in a smooth rollover movement. Finally, the orthosis switches shortly before the toes leave the ground.

Swinging Forward and Stepping Down

The orthosis resistance in the knee joint is now minimal. This allows the leg to swing forward with the help of a slight movement from the hip. In the final phase of a step, the C-Brace gently dampens the movement, even at changing walking speeds.

Benefits of the C-Brace

  • Natural movement patterns.
  • Controlled walking, including on uneven ground.
  • Easier walking on inclines.
  • Walking down stairs step-over-step.
  • Sitting down in a controlled movement.
  • Walking requires less physical exertion.
  • The need for compensating movements is reduced, improving body posture and reducing subsequent damage.
  • The movable ankle joint enables a more natural footfall and rollover.
  • The user can look ahead.
  • Inconspicuous to wear, also under clothing.
  • High-performance battery lasts all day when fully charged.
  • Notification sound indicates that battery is too low – automatic safety mode is activated.
  • User-defined mode can be selected, e.g., for cycling.
  • Smartphone app for adjusting modes.

Indication

In principle, the C-Brace can be considered for all neurological indications of the lower limbs. The leading indications are incomplete paraplegia (lesion between L1 and L5) with very minor or no spasticity as well as post-polio syndrome, the condition following poliomyelitis.

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CASE STUDIES

  1. Schmalz T, Pröbsting E, Auberger R, Siewert G. A functional comparison of conventional knee-ankle-foot orthoses and a microprocessor-controlled leg orthosis system based on biomechanical parameters. Prosthet Orthot Int published online 23 September 2014, DOI: 10.1177/0309364614546524.
    Abstract: The microprocessor-controlled leg orthosis C-Brace enables patients with paretic or paralyzed lower limb muscles to use dampened knee flexion under weight-bearing and speed-adapted control of the swing phase. The objective of the present study was to investigate the new technical functions of the C-Brace orthosis, based on biomechanical parameters. The study enrolled six patients. The C-Brace orthosis is compared with conventional leg orthoses (four stance control orthoses, two locked knee-ankle-foot orthoses) using biomechanical parameters of level walking, descending ramps and descending stairs. Ground reaction forces, joint moments and kinematic parameters were measured for level walking as well as ascending and descending ramps and stairs. RESULTS: With the C-Brace, a nearly natural stance phase knee flexion was measured during level walking (mean value 11° ± 5.6°). The maximum swing phase knee flexion angle of the C-Brace approached the normal value of 65° more closely than the stance control orthoses (66° ± 8.5° vs 74° ± 6.4°). No significant differences in the joint moments were found between the C-Brace and stance control orthosis conditions. In contrast to the conventional orthoses, all patients were able to ambulate ramps and stairs using a step-over-step technique with C-Brace (flexion angle 64.6° ± 8.2° and 70.5° ± 12.4°). CONCLUSION: The results show that the functions of the C-Brace for situation-dependent knee flexion under weight bearing have been used by patients with a high level of confidence. For more information, visit ncbi.nlm.nih.gov.

  2. Pröbsting E, Kannenberg A, Zacharias B. Safety and walking ability of KAFO users with the C-Brace® Orthotronic Mobility System, a new microprocessor stance and swing control orthosis. Prosthet Orthot Int 2017; Feb;41(1):65-77. PMID: 27151648.
    Abstract: There are clear indications for benefits of stance control orthoses compared to locked knee ankle foot orthoses. However, stance control orthoses still have limited function compared with a sound human leg. The aim of this study was to evaluate the potential benefits of a microprocessor stance and swing control orthosis compared to stance control orthoses and locked knee ankle foot orthoses in activities of daily living. Thirteen patients with various lower limb pareses completed a baseline survey for their current orthotic device (locked knee ankle foot orthosis or stance control orthosis) and a follow-up for the microprocessor stance and swing control orthosis with the Orthosis Evaluation Questionnaire, a new self-reported outcome measure devised by modifying the Prosthesis Evaluation Questionnaire for use in lower limb orthotics and the Activities of Daily Living Questionnaire. RESULTS: The Orthosis Evaluation Questionnaire results demonstrated significant improvements by microprocessor stance and swing control orthosis use in the total score and the domains of ambulation (p = .001), paretic limb health (p = .04), sounds (p = .02), and well-being (p = .01). Activities of Daily Living Questionnaire results showed significant improvements with the microprocessor stance and swing control orthosis with regard to perceived safety and difficulty of activities of daily living. CONCLUSION: The microprocessor stance and swing control orthosis may facilitate an easier, more physiological, and safer execution of many activities of daily living compared to traditional leg orthosis technologies. For more information, visit journals.sagepub.com.

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PROFILE

Edward Lemaire, Ph.D

Edward Lemaire's research and development activities involve technological and biomechanical solutions that improve physical rehabilitation outcomes, improve access to services, and enhance efficiency. To accomplish these objectives he works with researchers, healthcare providers, and students from human kinetics, engineering, computer science, medicine, and rehabilitation sciences. Most of this research occurs through the IRRD Rehabilitation Technology Lab (The Institute for Rehabilitation and Development/The Ottawa Hospital Rehabilitation Center).

His research interests include:

  • Mobility / assistive device research and development (prosthetics, orthotics, wearable robotics, etc.).
  • Telehealth / telemedicine / telerehabilitation (Remote consultation, remote assessment, Internet application for rehabilitation).
  • Biomechanical analysis of motion.
  • Virtual applications for rehabilitation (Virtual reality therapy, CAD/CAM for clinical applications, etc.).
  • SmartPhone applications for mobility analysis.

In addition to academic appointments in the University of Ottawa Faculty of Medicine and Health Sciences, Dr. Lemaire is a member of the Ottawa-Carleton Institute for Computer Science and the Ottawa-Carleton Institute for Biomedical Engineering.

Currently. he is president of the International Society for Prosthetics and Orthotics (ISPO) and serves on the ISPO International Scientific Committee.

Dr. Lemaire received his Ph.D., in bioengineering from the University of Strathclyde (Glasgow, Scotland) and MSc in biomechanics from the University of Ottawa.

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LEGISLATIVE NEWS

The Department of Defense (DoD) published the proposed regulations to add PTAs and OTAs as TRICARE-authorized providers to engage in physical therapy or occupational therapy under the supervision of a TRICARE-authorized physical therapist or occupational therapist in accordance with Medicare's rules for supervision and qualification when billed under the supervising therapist's national provider identification number. This rule will align TRICARE with Medicare's policy, which permits PTAs or OTAs to provide physical or occupational therapy when supervised by and billed under a licensed or certified physical therapist or occupational therapist.

  1. Purpose of the Proposed Rule

This proposed rule implements section 721 of the National Defense Authorization Act for Fiscal Year 2018 (NDAA-18), and advances two of the components of the Military Health System's quadruple aim of improved readiness and better health. The TRICARE Basic benefit currently includes physical therapy (PT) and occupational therapy (OT) services rendered by TRICARE-authorized providers within the scope of their license when prescribed and monitored by a physician, certified physician assistant, or certified nurse practitioner. Allowing authorized physical therapists and occupational therapists to include as covered services those services of qualified assistants performing under their supervision may increase access to PT and OT services, and increase beneficiary choice in provider selection. Physical therapists and occupational therapists will be available to attend to more complex tasks for TRICARE beneficiaries, delegating to assistants simpler tasks for which they are licensed or certified to carry out. Adding coverage of services by authorized therapy assistants increases access at the same time the Agency anticipates that an active and aging beneficiary population will increasingly use these services.

  1. Summary of the Major Provisions of the Proposed Rule

The major provisions of the proposed rule are:

The addition of licensed or certified PTAs as TRICARE-authorized providers, operating under the same qualifications established by Medicare (42 Code of Federal Regulations (CFR) 484.4). Services must be furnished under the supervision of and billed by a licensed or certified TRICARE-authorized physical therapist.

The addition of licensed or certified OTAs as TRICARE-authorized providers, operating under the same qualifications established by Medicare (42 CFR 484.4). Services must be furnished under the supervision of and billed by a licensed or certified TRICARE-authorized occupational therapist.

Introduction and Background

Title 32 CFR 199.4(c)(3)(x) states that assessment and treatment services of a TRICARE authorized physical therapist or occupational therapist may be cost-shared under certain conditions when prescribed and monitored by a physician, certified physician assistant, or certified nurse practitioner. In addition, 32 CFR 199.6(c)(3)(iii)(K)(2) recognizes licensed registered physical therapists and licensed registered occupational therapists as TRICARE authorized providers when PT and OT services meet the conditions and are prescribed and monitored as described in the previous sentence. This rule proposes to extend coverage of PT and OT services, as required by NDAA-18, to include services provided by licensed or certified physical or occupational therapy assistants operating under the supervision of a TRICARE-authorized physical therapist or occupational therapist.

PTAs—Supervision Requirements

Under this rule, TRICARE's supervision requirements match Medicare's. The DHA intends, in implementing instructions, to follow Medicare's requirements as found within Medicare's Benefit Policy Chapter 15.6 Part C and other issuances regarding supervision of PTAs. Direct supervision (i.e., the supervising physical therapist is in the room with the PTA) will be required in a private practice setting, whereas general supervision (i.e., the supervising physical therapist is not present but is available and remains responsible for the course of treatment) will be required in most other instances. In cases of general supervision, the supervising physical therapist will be required to make an onsite supervisory visit at least once every 30 days. In cases where state or local supervision laws are more stringent, the DHA will require physical therapists and the PTAs they supervise to follow state or local laws. Services provided by physical therapy aides or other personnel, even if under the supervision of a qualified physical therapist or physical therapy assistant, are not covered. Services provided by PTAs incident to services provided by physicians or other licensed or qualified providers other than physical therapists are not covered, as only physical therapists can supervise PTAs. If Medicare makes changes to its supervision requirements, the DHA will evaluate the changes and determine whether to make similar changes; any changes deemed appropriate shall be added to the implementing instructions.

Services provided by a PTA beyond the scope permitted by state or local law shall not be reimbursed.

OTAs—Supervision Requirements

Under this proposed rule, TRICARE's supervision requirements match Medicare's. The DHA intends, in implementing instructions, to follow Medicare's requirements as found within Medicare's Benefit Policy Chapter 15.6 Part C and other issuances regarding supervision of OTAs. Direct supervision (i.e., the supervising occupational therapist is in the room with the OTA) will be required in a private practice setting, whereas general supervision (i.e., the supervising occupational therapist is not present but is available and remains responsible for the course of treatment) will be required in most other instances. In cases of general supervision, the supervising occupational therapist will be required to make an onsite supervisory visit at least once every 30 days. In cases where state or local supervision laws are more stringent, the DHA will require occupational therapists and the OTAs they supervise to follow state or local laws. Services provided by occupational therapy aides or other personnel, even if under the supervision of a qualified occupational therapist or occupational therapy assistant, are not covered. Services provided by OTAs incident to services provided by physicians or other licensed or qualified providers other than occupational therapists are not covered, as only occupational therapists can supervise OTAs. If Medicare makes changes to its supervision requirements, the DHA will evaluate the changes and determine whether to make similar changes; any changes deemed appropriate shall be added to the implementing instructions.

For more details, visit the office of the Federal Register, FederalRegister.gov.

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CONFERENCE

NEXT APTA Conference and Exposition, Chicago, June 12-15, 2019. Visit APTA.org/NEXT

Association of Children’s Prosthetic Orthotic Clinic (ACPOC) 2019 Meeting, Clearwater, Florida, May 1-4, 2019. Visit Ebus.specacpoc.org

American Orthotic Prosthetic Association (AOPA) National Assembly, San Diego, Sept. 25-28. Visit Aopanet.org

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Educational Workshops and Inservices

Orthologix is available to present educational workshops and inservices for your group or your facility. Email us at info@orthologix.com to schedule.

Orthologix Clinical Update