Resources

Research – A Standard Set of Upper Extremity Tasks for Evaluating Rehabilitation Interventions for Individuals with Complete Arm Paralysis

—We have developed a set of upper-limb functional tasks to guide the design and test the performance of rehabilitation technologies that restore arm motion in people with high tetraplegia. Our goal was to develop a short set of tasks that would be representative of a much larger set of activities of daily living (ADLs), while also being feasible for a user of a unilateral, implanted functional electrical stimulation (FES) system. To compile this list of tasks, we reviewed existing clinical outcome measures related to arm and hand function and were further informed by surveys of patient desires. We ultimately selected a set of five tasks that captured the most common components of movement seen in ADLs and is therefore highly relevant for assessing FES-restored unilateral arm function in individuals with high cervical spinal cord injury. The tasks are intended to be used when setting design specifications and for evaluating and standardizing rehabilitation technologies under development. While not unique, this set of tasks will provide a common basis for comparing different interventions (e.g., FES, powered orthoses, robotic assistants) and testing different user command interfaces (e.g., sip-and-puff, head joysticks, brain-computer interfaces)

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Research – Upper Extremity Orthoses Use in Amyotrophic Lateral Sclerosis/Motor Neuron Disease

Central to the armamentarium of a hand therapist is evaluation for successful orthotic use. Orthoses can have a profound effect on quality of life in persons with amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). The purposes of orthoses are to decrease the effects of muscle imbalance, provide assistance in performance of activities of daily living (ADLs), prevent joint contracture, and relieve pain. There are few published accounts on the usefulness of orthoses and ALS. The purpose of this paper is to expand the body of literature by describing three successful cases.

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Research – Health and Economic Benefits of Physical Activity for Patients with Spinal Cord Injury

Spinal cord injury (SCI) is a traumatic, life-disrupting event with an annual incidence of 17,000 cases in the US. SCI is characterized by progressive physical deconditioning due to limited mobility and lack of modalities to allow safe physical activity that may partially offset these deleterious physical changes. Approximately, 50% of patients with SCI report no leisure-time physical activity and 15% report leisure-time physical activity below the threshold where meaningful health benefits could be realized. Collectively, about 363,000 patients with SCI, or 65% of the entire spinal cord injured population in the US, engages in insufficient physical activity and represents a target population that could derive considerable health benefits from even modest physical activity levels. Currently, the annual direct costs related to SCI exceed US$45 billion in the US. Rehabilitation protocols and technologies aimed to improve functional mobility have potential to significantly reduce the risk of medical complications and cost associated with SCI. Patients who commence routine physical activity in the first post-injury year and experience typical motor function improvements would realize US$290,000 to US$435,000 in lifetime cost savings, primarily due to fewer hospitalizations and less reliance on assistive care. New assistive technologies that allow patients with SCI to safely engage in routine physical activity are desperately needed.

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Research – The Economic Impact of Caregiving

The share of American adults providing uncompensated care to friends or family members with serious medical conditions and the elderly is growing rapidly. It can be extremely difficult to get a good handle on who and where these caregivers are, making it even more difficult to answer key questions about the impact of caregiving on important facets of daily life, especially the economy.

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Research – Index of Independence in Activities of Daily Living

The Index of Independence in Activities of Daily Living (Index of ADL; Katz et al., 1963) is a measure of function which can be used in objective evaluations of chronically ill and ageing populations. This measure was developed from observations of a large number of activities performed by a group of patients with fracture of the hip. The Index permits ranking of individuals according to adequacy of performance. Adequacy is expressed as a grade (A, B, C, D, E, F, G, or Other) which summarizes overall performance in six functions, namely, bathing, dressing, going to toilet, transferring, continence, and feeding. The form that has been developed for recording ADL evaluations includes three descriptions of each function. For each function, the observer checks the one description that is appropriate to the subject. More than 2,000 evaluations of 1,001 individuals demonstrated use of the Index as a survey instrument, as an objective guide to the course of chronic illness, as a tool for studying the aging process, and as an aid in rehabilitation teaching. (APA PsycTests Database Record (c) 2019 APA, all rights reserved)

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Research — Feasibility and Effectiveness of a Novel Dynamic Arm Support in Persons with Spinal Muscular Atrophy and Duchenne Muscular Dystrophy

Neuromuscular disorders (NMD) commonly affect the upper extremity. Due to muscle weakness, performance of daily activities becomes increasingly difficult, which leads to reduced independence and quality of life. In order to support the performance of upper extremity tasks, dynamic arm supports may be used. The Yumen Arm is a novel dynamic arm support specially developed for people with NMD. The aim of this study is to evaluate the feasibility and effectiveness of the Yumen Arm in persons with Duchenne Muscular Dystrophy (DMD) and persons with Spinal Muscular Atrophy (SMA).

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Research — Rehabilitative and Assistive Wearable Mechatronic Upper-limb Devices: A Review

Recently, there has been a trend toward assistive mechatronic devices that are wearable. These devices provide the ability to assist without tethering the user to a specific location. However, there are characteristics of these devices that are limiting their ability to perform motion tasks and the adoption rate of these devices into clinical settings. The objective of this research is to perform a review of the existing wearable assistive devices that are used to assist with musculoskeletal and neurological disorders affecting the upper limb. A review of the existing literature was conducted on devices that are wearable, assistive, and mechatronic, and that provide motion assistance to the upper limb. Five areas were examined, including sensors, actuators, control techniques, computer systems, and intended applications. Fifty-three devices were reviewed that either assist with musculoskeletal disorders or suppress tremor. The general trends found in this review show a lack of requirements, device details, and standardization of reporting and evaluation. Two areas to accelerate the evolution of these devices were identified, including the standardization of research, clinical, and engineering details, and the promotion of multidisciplinary culture. Adoption of these devices into their intended application domains relies on the continued efforts of the community.

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What are the Abilitech™ Assist device’s contraindications?

The Abilitech™ Assist is for individuals with neuromuscular weakness of their arms, and patients need intrinsic strength to benefit from this technology. This level of function is correlated to a manual muscle test score of a 2- to a 3+ for shoulder and elbow flexion.

Contraindications include:
• Grade two pressure injury or greater in area that may be impacted by the device wear
• Significantly unstable upper extremity joints
• Unhealed bone fractures in the upper extremities
• Inability to perform passive shoulder abduction of 120 degrees
• Inability to perform 90 degrees of passive elbow extension.

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What determines if the Abilitech™ Assist is a medical necessity?

To substantiate medical necessity for the Abilitech™ Assist, clinicians will document — and insurance companies will review — coverage criteria and requirements and Letters of Medical Necessity on a case-by-case basis.

To qualify for the Abilitech™ Assist, patients must have an upper limb that is weakened but still has intrinsic strength equivalent to a manual muscle test score of
2 or higher in the shoulder and arm. Letters of Medical Necessity will also cite a patient’s interests and motivations for the technology and explain why other, standard orthotics aren’t able to adequately facilitate the patient’s desired activities of daily living.

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What makes the Abilitech™ Assist unique?

The Abilitech™ Assist is the only body-worn device that provides a hybrid assist at the shoulder and elbow. The technology uses springs, motors and software to optimize the support needed for each individual without overriding their existing function. Each patient can dynamically adjust their profile with the touch of a button to support lifting of different weighted objects. The Abilitech™ Assist is lightweight, comfortable and easy to use.

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What is the Abilitech™ Assist’s billing code?

The HCPCS code for the Abilitech™ Assist is L3999 (Upper limb orthosis, not otherwise specified. Upper extremity SEWO multi-axis functional support assist hybrid device, custom calibrated spring tension with motorized adjustment, shoulder abduction & adduction; includes body worn vest with integrated lumbar sacral orthosis, lithium ion battery pack, all components and accessories, custom fit.)

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Where can I obtain the Abilitech™ Assist?

The Abilitech™ Assist is commercially available to individuals in the U.S.

It can be prescribed by clinicians and submitted for insurance approval, or it can be purchased outright. In either case, an in-person evaluation must occur to ensure the product is clinically and medically necessary and to demonstrate and provide education for its use.

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What determines if the Abilitech™ Assist device is right for someone?

The Abilitech™ Assist is for individuals with neuromuscular weakness of their arms, and patients need intrinsic strength to benefit from this technology. This level of function is correlated to a manual muscle test score of a 2- to a 3+ for shoulder and elbow flexion.

Contraindications include:
• Grade two pressure injury or greater in area that may be impacted by the device wear
• Significantly unstable upper extremity joints
• Unhealed bone fractures in the upper extremities
• Inability to perform passive shoulder abduction of 120 degrees
• Inability to perform 90 degrees of passive elbow extension.

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How long have upper-arm orthoses existed?

Upper-arm orthotic devices debuted in the U.S. in 1930s during the polio epidemic. These devices became part of the standard of care within clinic settings the 1960s. The first IP piling for the Abilitech™ Assist and its novel ability to support the shoulder with springs and counterbalance was filed in December 2016.

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How important are caregivers to improved upper-arm function?

Support from caregivers has been shown to be an important determinant of improved upper-limb function. Beyond caregivers’ abilities to address the physical, social and emotional wellbeing of those they care for, caregivers have been shown to be a determinant of improved upper-limb function in certain conditions, such as in the context of a stroke rehabilitation.

The Abilitech Assist is designed to be used in the presence of a trained caregiver who can help don and doff the device and periodically adjust.

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Which innovations are changing upper-arm orthotics?

Today’s upper-limb orthotic innovations increasingly consist of lightweight materials, advanced sensors and/or microprocessors, high-density batteries, and powerful actuation systems. Some even contain onboard memory to capture and communicate usage and biometric data.

Abilitech Medical leverages many of these advances in material science and has made its Abilitech Assist serve a body part otherwise unsupported by powered upper limb orthotics — the shoulder. The Abilitech™ Assist supports both the shoulder and the elbow, allowing certain individuals with minimal strength to have independent movement.

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How important is it for assistive devices to be used at home?

Many kinds of at-home technologies exist to enhance the independence of persons with disabilities.

Research surrounding home-based adaptations and assistive technology meant for older adults has shown that these technologies can substitute for and supplement formal care, and in most cases the initial investment in adaptations and assistive devices is recouped through subsequently lower care costs throughout a user’s life.

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What’s the average financial cost of an upper-extremity injury?

The cost of an upper-extremity injury depends on multiple factors, including severity of injury, any surgeries involved, underlying neuromuscular condition, length of stay, and more. The average direct acute care costs associated with SCI injuries in the US are estimated to be $181,093 U.S., a number which does not include indirect costs including, but not limited to, paying for outside care and lost wages and productivity.

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Why is providing shoulder assistance meaningful and unique?

Shoulders are involved with just about every body movement. Whether it’s getting out of bed, raising a fork or spoon to the mouth or reaching to get a glass from the cabinet, they are extremely consequential to individuals’ abilities to engage in their environments. Notably, the shoulder is responsible for maintaining the widest range of motion of any joint in the human body.

Shoulder function helps regulate arm mobility and arm stability. The glenohumeral joint and the segments of the shoulder girdle facilitate the former. Shoulder muscles, in combination with the glenohumeral capsule, labrum and ligaments, are responsible for the latter.

The Abilitech™ Assist is the only body-worn device that provides a hybrid assist at the shoulder and elbow.

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How much arm motion do people need in order to work?

The level of arm mobility required to work depends on the job, but many roles exist that can be performed with weaker functioning or non-functioning arms. In the U.S., individuals must be able to perform the tasks essential to the job, with or without reasonable accommodation, to qualify for protection from the ADA.

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What does an Abilitech Assist tele-evaluation consist of?

Abilitech Medical’s tele-evaluation is a free and confidential assessment that occurs virtually through HIPAA-compliant video conferencing on a patient’s camera-enabled computer, smartphone or tablet.

The evaluation typically lasts 30 minutes. Patients are asked to perform specific movements demonstrating their unaided upper-limb strength and ranges of motion. They’ll also be asked general questions about their medical history, insurance details and contact information.

It is suggested that caregivers be on hand for the evaluation, though their involvement is not necessarily imperative. Patients are asked to share any accommodations they need for hearing impairments, non-English language translations or similar prior to the evaluation.

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