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CADTH ISSUES IN EMERGING HEALTH TECHNOLOGIES INFORMING DECISIONS ABOUT NEW HEALTH TECHNOLOGIES ISSUE OCT 142 2015 Liftware: Self-stabilizing Eating Utensils for Individuals With Hand Tremor Author: N. Smith. Disclaimer: CADTH Issues in Emerging Health Technologies is a series of bulletins describing health technologies that are not yet used (or widely diffused) in Canada. The contents are based on information from early experience with the technology; however, further evidence may become available in the future. These summaries are not intended to replace professional medical advice. They are compiled as an information service for those involved in planning and providing health care in Canada. While the Canadian Agency for Drugs and Technologies in Health (CADTH) has taken care in the preparation of this publication to ensure that its contents are accurate, complete, and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this publication or in any of the source documentation. This document and the information provided in this document are prepared and intended for use in the context of the Canadian health care system. Other health care systems are different; the issues and information related to the subject matter of this document may be different in other jurisdictions and, if used outside of Canada, it is at the user’s risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. Copyright © CADTH 2015. You are permitted to reproduce this document for non-commercial purposes, provided it is not modified when reproduced and appropriate credit is given to CADTH. About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system. Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec. Views: The views expressed herein are those of CADTH and do not necessarily reflect the views of our funders. Cite as: Liftware: self-stabilizing eating utensils for individuals with hand tremor. Ottawa: CADTH; 2015 August. (CADTH issues in emerging health technologies; issue 142) Contact [email protected] with inquiries about this notice or legal matters relating to CADTH services. ISSN: 1488-6324 ISSUES IN EMERGING HEALTH TECHNOLOGIES 2 Summary •Liftware is a self-stabilizing, computerized handle and selection of attachments, including a spoon. It compensates for hand tremor, enabling people with mild to moderate tremor due to conditions such as essential tremor, Parkinson disease, or other neurological disorders to eat more easily. •The handle uses computer technology to sense the direction of tremor and move the utensil attachment in the opposite direction. •One small pilot study, led by the developers of Liftware, found that the device reduced tremor amplitude by 71% to 76% during three tasks: holding, lifting, and transferring. Background Tremor is the repetitive, involuntary shaking of a body part, characterized by small, oscillating (back-and-forth) movements.1 Everyone experiences slight trembling, which is noticeable when you hold your hands in front of you and try to keep them still.2 However, more severe tremors accompany a number of conditions, including neurological disorders such as essential tremor or Parkinson disease.1 Essential tremor is the most common movement disorder and the tremor may affect the hands, arms, legs, trunk, head, or vocal cords.3,4 Shaking in essential tremor worsens both with movement and when holding a static posture, but may stop when the limbs are at rest. In Parkinson disease, tremor often begins in one hand, and may spread over one side of the body to the arm, leg, and foot.5 Over time, the tremor may also affect the opposite side of the body, the chin, lips, and trunk.1 ISSUES IN EMERGING HEALTH TECHNOLOGIES People with tremor often have difficulty performing activities of daily living such as eating, writing, and grooming, which limits their independence. Because tremor limits tasks that require fine motor control, using eating utensils can be challenging and may discourage people from sharing meals with family and friends. Embarrassment about tremor can be as emotionally burdensome as the accompanying physical limitations, causing some individuals to avoid social situations and significantly reducing their quality of life.6,7 The Technology The Liftware spoon is a self-stabilizing utensil that compensates for hand tremor. This non-invasive, assistive device includes a stabilizing handle, rechargeable battery, and three attachments: a soup spoon, everyday spoon, and fork.8 A computer and two motors embedded in the handle act as a sensing mechanism (Active Cancellation of Tremor technology), which detects the direction of tremor and moves the utensil attachment in the opposite direction.9 3 Weighing approximately 100 grams, and similar in size to an electric toothbrush, Liftware is intended for use in restaurants and at social occasions, as well as at home.8,9 The rechargeable battery can run continuously for 90 minutes, and automatically turns off when the spoon is placed face-down.8,9 The Liftware utensil heads detach from the stabilizing handle for cleaning. Liftware eating utensils may help those with mild to moderate tremor, but are not intended for individuals with severe tremor.10 Regulatory Status Liftware was developed by Lift Labs (Mountainview, California), a subsidiary of Google.11 In Canada, Liftware is not considered to be a medical device as defined by the Food and Drugs Act and Medical Devices Regulations, and potential marketing of the device will be regulated under the Consumer Product Safety Act. Liftware is not currently available in Canada, but is sold online in the United States. Patient Group Parkinson disease affects approximately 100,000 Canadians.12 Most individuals with Parkinson (70% to 100%) will experience tremor.13 While neurologists and researchers generally agree on the symptoms of essential tremor, there is no standard definition and diagnostic error is common.3 Many cases are not diagnosed, making it difficult to determine the number of people affected.3 Some population-based studies suggest a prevalence rate of 0.4% to 3.9%, but these figures are likely underestimates.14 Both essential tremor and Parkinson disease are more prevalent in the elderly.3,15,16 Current Practice Currently available treatments for both essential tremor and Parkinson disease are used to control the symptoms, rather than cure the condition. Treatment of essential tremor depends upon which parts of the body are affected and the degree to which the condition disrupts activities of daily living.17 Patients with tremor are advised to make lifestyle changes, such as avoiding caffeine and participating in stress-relieving ISSUES IN EMERGING HEALTH TECHNOLOGIES activities.18 Medications are prescribed if lifestyle changes fail to provide relief. Propranolol, a beta blocker, and primidone, an anticonvulsant, are two medications commonly used to alleviate symptoms of essential tremor.3,17 The 2012 Canadian Guidelines on Parkinson’s Disease recommend that motor symptoms be treated with levodopa in combination with carbidopa or benserazide.19 As the disease progresses and symptoms worsen, increasing doses of the drugs are used.19 Because only one study has evaluated the Liftware spoon, there is limited evidence of its effectiveness. Two surgical procedures, thalamotomy and deep brain stimulation, may be used to reduce the severity of tremor in essential tremor and advanced Parkinson disease.17,19 More commonly used for individuals with essential tremor, thalamotomy involves inserting a liquid nitrogen probe into the brain to create lesions on a small area within the thalamus.20 In deep brain stimulation, an electrode is implanted in the brain to deliver electrical impulses to the surrounding tissue.21,22 The electrode is controlled by a pacemakerlike device, placed in the abdomen or upper chest.21,22 Methods — Literature Search A peer-reviewed literature search was conducted using the following bibliographic databases: MEDLINE, PubMed, Embase, and the Cochrane Library. Grey literature was identified by searching relevant sections of the Grey Matters checklist (http:// www.cadth.ca/resources/grey-matters). No methodological filters were applied. The search was limited to English-language documents published between January 1, 2010 and March 10, 2015. Regular alerts were established to update the search until May 2015. The Evidence Because only one study has evaluated the Liftware spoon, there is limited evidence of its effectiveness. Fifteen participants with essential tremor were enrolled in a single-arm pilot study; however, accelerometer data for four participants were excluded 4 Images courtesy of Liftware for technical reasons.9 The conclusions were based on results from 11 participants (nine men and two women), with a mean age of 70 years.9 Although Liftware is marketed for individuals with Parkinson disease, essential tremor, and other tremor disorders, only patients with essential tremor were included in the study. In this study, the participants used the device to perform three tasks: holding (holding the spoon between the table and the body), eating (lifting a spoonful of foam blocks to the mouth), and transferring items from one dish to another.9 The participants performed each task twice, with the device both on and off. Participants were randomly assigned to complete their first set of tasks with the device either on or off, with their second set of tasks using the other setting. Neither the subjects nor the neurologists knew whether the device was on or off during each round of testing.9 Because foam blocks were substituted for food in the study, it is not clear whether Liftware enables individuals to successfully eat lower-viscosity foods, such as soups or cereal with milk. The weight and dimensions of the foam blocks were not reported. Researchers embedded accelerometers (devices that measure acceleration) in the spoonís handle, to record tremor magnitude.9 The Fahn-Tolosa-Marin Tremor Rating Scale (with adapted items for feeding, pouring, and upper limb tremor) was used to measure the degree of tremor in the tip of the spoon during each task.9 Researchers did not specify how the tremor rating scale was adapted, and whether this modification provides valid ratings is not known.9 ISSUES IN EMERGING HEALTH TECHNOLOGIES To capture patient experience with the device, participants were asked to rate their level of improvement after each action using the seven-point Clinical Global Impression Scale (CGI-S).9 Results showed significant improvements in tremor rating scale scores across the three tasks with the technology turned on. Accelerometer data displayed average tremor reductions of 72%, 76%, and 71% in the holding, eating, and transferring tasks, respectively.23 Participantsí CGI-S scores also improved in the eating and transferring tasks, but indicated no change in the holding task.9 Two participants with severe tremor were unable to complete the tasks with their deep brain stimulation therapy devices turned off, which suggests that Liftware may be helpful only in those with mild to moderate tremor.9 Adverse Effects No adverse effects were reported in the pilot study. Administration and Cost Liftware’s “starter kit” — which includes the stabilizing handle, charging cradle, soup spoon attachment, and storage pouch — retails at US$295, and can be purchased online in the United States.24 The fork and everyday spoon attachments are sold separately for US$19.95. 5 Concurrent Developments The International Essential Tremor Foundation and other self-help guidelines suggest that weighted eating utensils may be helpful.10 However, weighted utensils may not be effective for,25 and may actually worsen tremor in, individuals with Parkinson disease.26 One study found that lightweight utensils, rather than heavy cutlery, enabled individuals with Parkinson disease to eat more easily.27 Rate of Technology Diffusion A recent review estimated that the incidence of Parkinson disease in Canada will increase considerably over the next 40 years (by about 50% from 2010 to 2050).15 Parkinson disease and essential tremor are both more prevalent in the elderly, and the numbers of those affected will likely rise with an aging population and increasing longevity.3,15,16 Demand for technologies that improve independence for those with tremor disorders could increase accordingly. Patient response to the device will influence the diffusion of this technology. An online video series, produced by Lift Labs, features three individuals with varying degrees of tremor using the Liftware spoon.28 The ability of each user to lift, hold, and eat a spoonful of food appears to improve with Liftware; one woman is shown successfully eating soup. Another online video, Introducing Liftware, produced by the developer, has received 525,640 views on YouTube since its release in September 2013.29 A profile of the Liftware spoon by a technology review Web series received 48,379 views in six months,30 and a home video of an elderly man using the spoon to eat a bowl of nuts gained 33,895 views in one year.31 The Web series and home video gave positive reviews of Liftware. While these clips do not provide clinical evidence of the spoonís effectiveness, viewership suggests that there is substantial public interest in these products. The International Essential Tremor Foundation has also promoted Liftware by circulating an advertisement for the technology to its members.32 Information on consumer satisfaction with Liftware and the number of spoons or kits sold was not available. Implementation Issues If Liftware becomes available in Canada, its eligibility for public reimbursement will need to be determined. As it is not considered to be a medical device, it may be considered instead as an assistive device or aid to daily living. ISSUES IN EMERGING HEALTH TECHNOLOGIES 6 References 1. National Institute of Neurological Disorders and Stroke (NINDS) [Internet]. Bethesda (MD): NINDS. Tremor fact sheet; 2015 [cited 2015 Apr 22]. Available from: http://www.ninds.nih.gov/disorders/tremor/detail_tremor.htm 2. NHS Choices [Internet]. London: National Health Service (NHS). Essential tremor; 2015 [cited 2015 Apr 22]. Available from: http://www.nhs.uk/ conditions/Tremor-%28essential%29/Pages/Introduction.aspx 18. Drain C. and Mid Essex Clinical Commissioning Group (NHS) [Internet]. Guideline for the treatment of essential tremor. Essex, England: Mid Essex Clinical Commissioning Group; 2013 [cited 2015 Apr 22]. Available from: http://midessexccg.nhs.uk/ 19. Canadian guidelines on Parkinson’s Disease. Can J Neurol Sci. 2012;39(4). Suppl 2. 3. International Essential Tremor Foundation. Essential tremor: what the experts say [Internet]. Lenaxa (KS): International Essential Tremor Foundation; 2014 [cited 2015 Jul 20]. Available from: http://www. essentialtremor.org/essential-tremor-what-the-experts-say/ 20. National Parkinson Foundation [Internet]. Miami (FL): National Parkinson Foundation; 2015. Thalamotomy; 2015 [cited 2015 Jul 20]. Available from: http://www.parkinson.org/Parkinson-s-Disease/Treatment/SurgicalTreatment-Options/Thalamotomy 4. International Essential Tremor Foundation [Internet]. Lenaxa (KS): International Essential Tremor Foundation. About essential tremor; 2015 [cited 2015 Jul 20]. Available from: http://www.essentialtremor.org/about-et/ 21. National Institute of Neurological Disorders and Stroke (NINDS) [Internet]. Bethesda (MD). NINDS deep brain stimulation for Parkinson’s Disease information page; 2015 [cited 2015 Apr 22]. Available from: http://www. ninds.nih.gov/disorders/deep_brain_stimulation/deep_brain_stimulation.htm 5. Parkinson’s UK [Internet]. London: Parkinson’s UK; 2015. Tremor and Parkinson’s; 2015 [cited 2015 Apr 22]. Available from: http://www. parkinsons.org.uk/content/tremor-and-parkinsons 6. Chandran V, Pal PK. Quality of life and its determinants in essential tremor. Parkinsonism Relat Disord. 2013 Jan;19(1):62-5. 7. Nazzaro JM, Pahwa R, Lyons KE. Long-term benefits in quality of life after unilateral thalamic deep brain stimulation for essential tremor. J Neurosurg. 2012 Jul;117(1):156-61. 8. Liftware [Internet]. San Francisco (CA): LiftLabs. Liftware: overview; 2015 [cited 2015 Jul 20]. Available from: www.google.com/liftware 9. Pathak A, Redmond JA, Allen M, Chou KL. A noninvasive handheld assistive device to accommodate essential tremor: a pilot study. Mov Disord. 2014 May;29(6):838-42. Available from: http://www.ncbi.nlm.nih. gov/pmc/articles/PMC4156033 10. Liftware [Internet]. San Francisco (CA): LiftLabs; 2015. Liftware: information for clinicians; 2015 [cited 2015 Jul 20]. Available from: http:// www.google.com/liftware/clinicians/ 11. Huett E. Google expands further into biotech, hardware with Lift Labs acquisition. Forbes [Internet]. 2014 Oct 9 [cited 2015 Jul 20]. Available from: http://www.forbes.com/sites/ellenhuet/2014/09/10/googleexpands-further-into-biotech-hardware-with-lift-labs-acquisition/ 12. Parkinson Society of Southwestern Ontario [Internet]. London (ON): Parkinson Society of Southwestern Ontario; 2015. Frequently asked questions; 2015 [cited 2015 Apr 15]. Available from: http://www. parkinsonsociety.ca/frequently-asked-questions.html 13. Frank C, Pari G, Rossiter JP. Approach to diagnosis of Parkinson’s disease. Can Fam Physician [Internet]. 2006 [cited 2015 Jun 18];52:862-8. Available from: http://www.cfp.ca/content/52/7/862.full.pdf 22. John Hopkins Medicine [Internet]. Baltimore (MD): The John Hopkins University; 2015. Deep brain stimulation; 2015 [cited 2015 Apr 22]. Available from: http://www.hopkinsmedicine.org/healthlibrary/test_ procedures/neurological/deep_brain_stimulation_135,38/ 23. Pathak A, Redmond JA, Allen M, Chou KL. Clinical evaluation of a handheld device for tremor [meeting abstract]. Neurology [Internet]. 2013 [cited 2015 Apr 22];80(Meeting Abstracts 1):S53.005. Meeting Abstracts. Available from: http://www.neurology.org/cgi/content/meeting_ abstract/80/1_MeetingAbstracts/S53.005 24. Liftware [Internet]. San Francisco (CA): LiftLabs. Liftware: all products; 2015 [cited 2015 Apr 22]. Available from: http://liftlabs.myshopify.com/ collections/all 25. Wong SL, Gilmour H, Ramage-Morin PL. Parkinson’s disease: prevalence, diagnosis and impact [Internet]. Ottawa: Statistics Canada; 2014 [cited 2015 Jun 21]. Available from: http://www.statcan.gc.ca/pub/82003-x/2014011/article/14112-eng.pdf 26. Heroux ME, Pari G, Norman KE. The effect of inertial loading on wrist postural tremor in essential tremor. Clin Neurophysiol. 2009 May;120(5):1020-9. 27. Ma HI, Hwang WJ, Tsai PL, Hsu YW. The effect of eating utensil weight on functional arm movement in people with Parkinson’s disease: a controlled clinical trial. Clin Rehabil. 2009 Dec;23(12):1086-92. 28. Liftware [Internet]. San Francisco (CA): LiftLabs. Liftware: how it works; 2015 [cited 2015 Apr 22]. Available from: http://www.google.com/liftware/how/ 29. YouTube [Internet]. San Bruno (CA): YouTube; 2015. Introducing Liftware [video]; 2013 [cited 2015 Apr 15]. Available from: https://www.youtube. com/watch?v=fS01kn6YJ94 14. Benito-Leon J, Louis ED. Essential tremor: emerging views of a common disorder. Nat Clin Pract Neurol. 2006 Dec;2(12):666-78. 30. YouTube [Internet]. San Bruno (CA): YouTube; 2015. Liftware spoon: Drunk Tech review [video]; 2014 [cited 2015 Apr 15]. Available from: https://www. youtube.com/watch?v=Y5Ms6QKyMx4 15. Bach JP, Ziegler U, Deuschl G, Dodel R, Doblhammer-Reiter G. Projected numbers of people with movement disorders in the years 2030 and 2050. Mov Disord. 2011 Oct;26(12):2286-90. 31. YouTube [Internet]. San Bruno (CA): YouTube; 2015. Liftware spoon [video]; 2013 [cited 2015 Apr 15]. Available from: https://www.youtube. com/watch?v=CcqoZWpbe54 16. Gazewood JD, Richards DR, Clebak K. Parkinson disease: an update. Am Fam Physician. 2013 Feb 15;87(4):267-73. 32. International Essential Tremor Foundation [Internet]. Lenaxa (KS): International Essential Tremor Foundation. Facts about essential tremor; 2015 [cited 2015 Apr 22]. Available from: http://www.essentialtremor.org/ wp-content/uploads/2013/07/FactSheet012013.pdf 17. Treatments for essential tremor [Internet]. St. Paul (MN): American Academy of Neurology; 2015 [cited 2015 Apr 22]. Available from: http:// tools.aan.com/professionals/practice/pdfs/ET_patients.pdf ISSUES IN EMERGING HEALTH TECHNOLOGIES 7