V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial

Anat Mirelman, Lynn Rochester, Miriam Reelick, Freek Nieuwhof, Elisa Pelosin, Giovanni Abbruzzese, Kim Dockx, Alice Nieuwboer, Jeffrey M Hausdorff, Anat Mirelman, Lynn Rochester, Miriam Reelick, Freek Nieuwhof, Elisa Pelosin, Giovanni Abbruzzese, Kim Dockx, Alice Nieuwboer, Jeffrey M Hausdorff

Abstract

Background: Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

Methods/design: Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson's disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function.

Discussion: This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit.

Trial registration: (NIH)-NCT01732653.

Figures

Figure 1
Figure 1
The V-TIME multi-modal intervention solution for reducing fall risk. Current treatment of fall risk focuses on motor, e.g., gait, problems. V-TIME focuses on both gait and cognitive deficits to optimally treat multiple, critical fall risk aspects and enhance mobility, physical activity and cognitive function. The current working version of V-TIME is shown. A patient trains on a treadmill while viewing a virtual environment that presents obstacles, different types of challenges, and feedback [49]. Written informed consent was obtained from the patient for publication of this case report and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal.
Figure 2
Figure 2
Summary of the study design and training protocol. TT: treadmill training. TT+VR: treadmill training augmented by the virtual reality simulation.

References

    1. Blake AJ, Morgan K, Bendall MJ. Falls by elderly people at home: prevalence and associated factors. Age Ageing. 1988;17(6):365–372. doi: 10.1093/ageing/17.6.365.
    1. Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988;319(26):1701–1707. doi: 10.1056/NEJM198812293192604.
    1. Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson’s disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002;72(6):721–725. doi: 10.1136/jnnp.72.6.721.
    1. Rubenstein LZ, Josephson KR. Falls and their prevention in elderly people: what does the evidence show? Med Clin North Am. 2006;90(5):807–824. doi: 10.1016/j.mcna.2006.05.013.
    1. Mackenzie L, Byles J, D’Este C. Validation of self-reported fall events in intervention studies. Clin Rehabil. 2006;20(4):331–339. doi: 10.1191/0269215506cr947oa.
    1. Sartini M, Cristina ML, Spagnolo AM. The epidemiology of domestic injurious falls in a community dwelling elderly population: an outgrowing economic burden. Eur J Public Health. 2010;20(5):604–606. doi: 10.1093/eurpub/ckp165.
    1. Axer H, Axer M, Sauer H, Witte OW, Hagemann G. Falls and gait disorders in geriatric neurology. Clin Neurol Neurosurg. 2010;112(4):265–274. doi: 10.1016/j.clineuro.2009.12.015.
    1. Hausdorff JM, Rios D, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001;82:1050–1056. doi: 10.1053/apmr.2001.24893.
    1. Auvinet B, Berrut G, Touzard C. Reference data for normal subjects obtained with an accelerometric device. Gait Posture. 2002;16(2):124–134. doi: 10.1016/S0966-6362(01)00203-X.
    1. Ashburn A, Stack E, Pickering RM, Ward CD. A community-dwelling sample of people with Parkinson’s disease: characteristics of fallers and non-fallers. Age Ageing. 2001;30(1):47–52. doi: 10.1093/ageing/30.1.47.
    1. Legters K. Fear of falling. Phys Ther. 2002;82(3):264–272.
    1. Hausdorff JM, Nelson ME, Kaliton D. Etiology and modification of gait instability in older adults: a randomized controlled trial of exercise. J Appl Physiol. 2001;90(6):2117–2129.
    1. Hausdorff JM, Yogev G, Springer S, Simon ES, Giladi N. Walking is more like catching than tapping: gait in the elderly as a complex cognitive task. Exp Brain Res. 2005;164(4):541–548. doi: 10.1007/s00221-005-2280-3.
    1. Hausdorff JM, Yogev G. Cognitive function may be important for fall injury prevention trials. J Am Geriatr Soc. 2006;54(5):865–866.
    1. Hausdorff JM, Doniger GM, Springer S, Yogev G, Giladi N, Simon ES. A common cognitive profile in elderly fallers and in patients with Parkinson’s disease: the prominence of impaired executive function and attention. Exp Aging Res. 2006;32(4):411–429. doi: 10.1080/03610730600875817.
    1. Allcock LM, Rowan EN, Wesnes K, Kenny RA, Burn DJ. Impaired attention: a risk factor for falls in Parkinson’s disease? Mov Disord. 2007;22:S204.
    1. Herman T, Mirelman A, Giladi N, Schweiger A, Hausdorff JM. Executive control deficits as a prodrome to falls in healthy older adults: a prospective study linking thinking, walking, and falling. J Gerontol A Biol Sci Med Sci. 2010;65(10):1086–1092.
    1. Holtzer R, Friedman R, Lipton RB, Katz M, Xue X, Verghese J. The relationship between specific cognitive functions and falls in aging. Neuropsychology. 2007;21(5):540–548.
    1. Holtzer R. Central control of mobility: evidence from cognitive, genetic and functional neuroimaging studies. Parkinsonism Relat Disord. 2010;16:S4–S5.
    1. Liu-Ambrose T, Katarynych LA, Ashe MC, Nagamatsu LS, Hsu CL. Dual-task gait performance among community-dwelling senior women: the role of balance confidence and executive functions. J Gerontol A Biol Sci Med Sci. 2009;64(9):975–982.
    1. Springer S, Giladi N, Peretz C, Yogev G, Simon ES, Hausdorff JM. Dual-tasking effects on gait variability: the role of aging, falls, and executive function. Mov Disord. 2006;21(7):950–957. doi: 10.1002/mds.20848.
    1. Ble A, Volpato S, Zuliani G. Executive function correlates with walking speed in older persons: The InCHIANTI study. J Am Geriatr Soc. 2005;53(3):410–415. doi: 10.1111/j.1532-5415.2005.53157.x.
    1. Sheridan PL, Hausdorff JM. The role of higher-level cognitive function in gait: executive dysfunction contributes to fall risk in Alzheimer’s disease. Dement Geriatr Cogn Disord. 2007;24(2):125–137. doi: 10.1159/000105126.
    1. van Iersel MB, Kessels RP, Bloem BR, Verbeek AL, Olde Rikkert MG. Executive functions are associated with gait and balance in community-living elderly people. J Gerontol A Biol Sci Med Sci. 2008;63(12):1344–1349. doi: 10.1093/gerona/63.12.1344.
    1. Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008;23(3):329–342. doi: 10.1002/mds.21720.
    1. Muir SW, Gopaul K, Montero Odasso MM. The role of cognitive impairment in fall risk among older adults: a systematic review and meta-analysis. Age Ageing. 2012;41(3):299–308. doi: 10.1093/ageing/afs012.
    1. Camicioli R, Howieson D, Lehman S, Kaye J. Talking while walking: the effect of a dual task in aging and Alzheimer’s disease. Neurology. 1997;48(4):955–958. doi: 10.1212/WNL.48.4.955.
    1. Hausdorff JM, Balash J, Giladi N. Effects of cognitive challenge on gait variability in patients with Parkinson’s disease. J Geriatr Psychiatry Neurol. 2003;16(1):53–58.
    1. Yogev G, Giladi N, Peretz C, Springer S, Simon ES, Hausdorff JM. Dual tasking, gait rhythmicity, and Parkinson’s disease: which aspects of gait are attention demanding? Eur J Neurosci. 2005;22(5):1248–1256. doi: 10.1111/j.1460-9568.2005.04298.x.
    1. Allcock LM, Rowan EN, Steen IN, Wesnes K, Kenny RA, Burn DJ. Impaired attention predicts falling in Parkinson’s disease. Parkinsonism Relat Disord. 2009;15(2):110–115. doi: 10.1016/j.parkreldis.2008.03.010.
    1. Aarsland D, Bronnick K, Larsen JP, Tysnes OB, Alves G. Cognitive impairment in incident, untreated Parkinson disease: the Norwegian ParkWest study. Neurology. 2009;72(13):1121–1126. doi: 10.1212/01.wnl.0000338632.00552.cb.
    1. Pagonabarraga J, Kulisevsky J. Cognitive impairment and dementia in Parkinson’s disease. Neurobiol Dis. 2012;46(3):590–596. doi: 10.1016/j.nbd.2012.03.029.
    1. Chapman GJ, Hollands MA. Evidence that older adult fallers prioritise the planning of future stepping actions over the accurate execution of ongoing steps during complex locomotor tasks. Gait Posture. 2007;26(1):59–67. doi: 10.1016/j.gaitpost.2006.07.010.
    1. Chen HC, Schultz AB, Ashton-Miller JA, Giordani B, Alexander NB, Guire KE. Stepping over obstacles: dividing attention impairs performance of old more than young adults. J Gerontol A Biol Sci Med Sci. 1996;51(3):M116–M122.
    1. Di Fabio RP, Greany JF, Zampieri C. Saccade-stepping interactions revise the motor plan for obstacle avoidance. J Mot Behav. 2003;35(4):383–397. doi: 10.1080/00222890309603158.
    1. Lowrey CR, Watson A, Vallis LA. Age-related changes in avoidance strategies when negotiating single and multiple obstacles. Exp Brain Res. 2007;182(3):289–299. doi: 10.1007/s00221-007-0986-0.
    1. Galna B, Murphy AT, Morris ME. Obstacle crossing in people with Parkinson’s disease: foot clearance and spatiotemporal deficits. Hum Mov Sci. 2010;29(5):843–852. doi: 10.1016/j.humov.2009.09.006.
    1. Galna B, Lord S, Daud D, Archibald N, Burn D, Rochester L. Visual sampling during walking in people with Parkinson's disease and the influence of environment and dual-task. Brain Res. 2012;1473:35–43.
    1. Menant JC, St George RJ, Fitzpatrick RC, Lord SR. Impaired depth perception and restricted pitch head movement increase obstacle contacts when dual-tasking in older people. J Gerontol A Biol Sci Med Sci. 2010;65(7):751–757.
    1. Brown LA, McKenzie NC, Doan JB. Age-dependent differences in the attentional demands of obstacle negotiation. J Gerontol A Biol Sci Med Sci. 2005;60(7):924–927. doi: 10.1093/gerona/60.7.924.
    1. Sparrow WA, Bradshaw EJ, Lamoureux E, Tirosh O. Ageing effects on the attention demands of walking. Hum Mov Sci. 2002;21(5–6):961–972.
    1. AGS Guidelines. Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001;49(5):664–672. doi: 10.1046/j.1532-5415.2001.49115.x.
    1. Gillespie LD, Robertson MC, Gillespie WJ. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009;2:CD007146.
    1. Hauer K, Becker C, Lindemann U, Beyer N. Effectiveness of physical training on motor performance and fall prevention in cognitively impaired older persons: a systematic review. Am J Phys Med Rehabil. 2006;85(10):847–857. doi: 10.1097/01.phm.0000228539.99682.32.
    1. Goodwin VA, Richards SH, Taylor RS, Taylor AH, Campbell JL. The effectiveness of exercise interventions for people with parkinson’s disease: a systematic review and meta-analysis. Mov Disord. 2008;23(5):631–640. doi: 10.1002/mds.21922.
    1. Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;4:CD000340.
    1. Kannus P, Parkkari J, Koskinen S. Fall-induced injuries and deaths among older adults. JAMA. 1999;281(20):1895–1899. doi: 10.1001/jama.281.20.1895.
    1. Mahoney JE. Why multifactorial fall-prevention interventions may not work: Comment on “Multifactorial intervention to reduce falls in older people at high risk of recurrent falls”. Arch Intern Med. 2010;170(13):1117–1119. doi: 10.1001/archinternmed.2010.193.
    1. Mirelman A, Maidan I, Herman T, Deutsch JE, Giladi N, Hausdorff JM. Virtual reality for gait training: can it induce motor learning to enhance complex walking and reduce fall risk in patients with Parkinson’s disease? J Gerontol A Biol Sci Med Sci. 2010.
    1. Burdea GC. Virtual rehabilitation–benefits and challenges. Methods Inf Med. 2003;42(5):519–523.
    1. de Bruin ED, Schoene D, Pichierri G, Smith ST. Use of virtual reality technique for the training of motor control in the elderly. Some theoretical considerations. Z Gerontol Geriatr. 2010;43(4):229–234. doi: 10.1007/s00391-010-0124-7.
    1. Mirelman A, Raphaeli Baer N, Dorfman M, Brozgol M, Giladi N, Hausdorff JM. Virtual Reality in Idiopathic fallers - A pilot study. Zurich: Conference proceedings from the International Conference for Virtual Reality; 2011.
    1. Nieuwboer A, Rochester L, Herman T. Reliability of the new freezing of gait questionnaire: agreement between patients with Parkinson’s disease and their carers. Gait Posture. 2009;30(4):459–463. doi: 10.1016/j.gaitpost.2009.07.108.
    1. Grabiner MD, Bareither ML, Gatts S, Marone J, Troy KL. Task-specific training reduces trip-related fall risk in women. Med Sci Sports Exerc. 2012;44(12):2410–4. doi: 10.1249/MSS.0b013e318268c89f.
    1. Pai YC, Bhatt T, Wang E, Espy D, Pavol MJ. Inoculation against falls: rapid adaptation by young and older adults to slips during daily activities. Arch Phys Med Rehabil. 2010;91(3):452–459. doi: 10.1016/j.apmr.2009.10.032.
    1. Weerdesteyn V, Rijken H, Geurts AC, Smits-Engelsman BC, Mulder T, Duysens J. A five-week exercise program can reduce falls and improve obstacle avoidance in the elderly. Gerontology. 2006;52(3):131–141. doi: 10.1159/000091822.
    1. Bilney B, Morris M, Webster K. Concurrent related validity of the GAITRite walkway system for quantification of the spatial and temporal parameters of gait. Gait Posture. 2003;17(1):68–74. doi: 10.1016/S0966-6362(02)00053-X.
    1. Hausdorff JM, Cudkowicz ME, Firtion R, Wei JY, Goldberger AL. Gait variability and basal ganglia disorders: stride-to-stride variations of gait cycle timing in Parkinson’s disease and Huntington’s disease. Mov Disord. 1998;13(3):428–437.
    1. Montero-Odasso M, Bergman H, Phillips NA, Wong CH, Sourial N, Chertkow H. Dual-tasking and gait in people with mild cognitive impairment. The effect of working memory. BMC Geriatr. 2009;9:41. doi: 10.1186/1471-2318-9-41.
    1. Brooks D, Davis AM, Naglie G. Validity of 3 physical performance measures in inpatient geriatric rehabilitation. Arch Phys Med Rehabil. 2006;87(1):105–110. doi: 10.1016/j.apmr.2005.08.109.
    1. Light KE, Behrman AL, Thigben M, Triggs WJ. The 2-minute walk test: a tool for evaluating endurance in clients with Parkinson’s disease. Neurol Rep. 1997;21:136–139.
    1. Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001;82(1):9–13. doi: 10.1053/apmr.2001.9396.
    1. Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002;83(11):1566–1571. doi: 10.1053/apmr.2002.35469.
    1. Freire AN, Guerra RO, Alvarado B, Guralnik JM, Zunzunegui MV. Validity and reliability of the short physical performance battery in two diverse older adult populations in quebec and Brazil. J Aging Health. 2012;24(5):863–878. doi: 10.1177/0898264312438551.
    1. King LA, Priest KC, Salarian A, Pierce D, Horak FB. Comparing the Mini-BESTest with the berg balance scale to evaluate balance disorders in Parkinson’s disease. Parkinsons Dis. 2012;2012:375419.
    1. Craig CL, Marshall AL, Sjostrom M. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–1395. doi: 10.1249/01.MSS.0000078924.61453.FB.
    1. Doniger GM, Simon ES, Zivotofsky AZ. Comprehensive computerized assessment of cognitive sequelae of a complete 12–16 hour fast. Behav Neurosci. 2006;120(4):804–816.
    1. Doniger GM, Dwolatzky T, Zucker DM. Computerized cognitive testing battery identifies mild cognitive impairment and mild dementia even in the presence of depressive symptoms. Am J Alzheimers Dis Other Demen. 2006;21(1):28–36. doi: 10.1177/153331750602100105.
    1. Herman T, Mirelman A, Giladi N, Schweiger A, Hausdorff JM. Executive control deficits as a prodrome to falls in healthy older adults: a prospective study linking thinking, walking, and falling. J Gerontol A Biol Sci Med Sci. 2010;65(10):1086–92.
    1. Mirelman A, Herman T, Brozgol M. Executive function and falls in older adults: new findings from a five-year prospective study link fall risk to cognition. PLoS One. 2012;7(6):e40297. doi: 10.1371/journal.pone.0040297.
    1. Hoops S, Nazem S, Siderowf AD. Validity of the MoCA and MMSE in the detection of MCI and dementia in Parkinson disease. Neurology. 2009;73(21):1738–1745. doi: 10.1212/WNL.0b013e3181c34b47.
    1. Nasreddine ZS, Phillips NA, Bedirian V. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–699. doi: 10.1111/j.1532-5415.2005.53221.x.
    1. Fals-Stewart W. An interrater reliability study of the Trail Making Test (Parts A and B) Percept Mot Skills. 1992;74(1):438–450.
    1. Sanchez-Cubillo I, Perianez JA, drover-Roig D. Construct validity of the Trail Making Test: role of task-switching, working memory, inhibition/interference control, and visuomotor abilities. J Int Neuropsychol Soc. 2009;15(3):438–450. doi: 10.1017/S1355617709090626.
    1. Cantin JF, McFadyen BJ, Doyon J, Swaine B, Dumas D, Vallee M. Can measures of cognitive function predict locomotor behaviour in complex environments following a traumatic brain injury? Brain Inj. 2007;21(3):327–334. doi: 10.1080/02699050701209972.
    1. Lezak MD. Neuropsychological assessment. Oxford: Oxford press; 2012.
    1. Riazi A, Hobart JC, Lamping DL. Using the SF-36 measure to compare the health impact of multiple sclerosis and Parkinson’s disease with normal population health profiles. J Neurol Neurosurg Psychiatry. 2003;74(6):710–714. doi: 10.1136/jnnp.74.6.710.
    1. Weinberger M, Nagle B, Hanlon JT. Assessing health-related quality of life in elderly outpatients: telephone versus face-to-face administration. J Am Geriatr Soc. 1994;42(12):1295–1299.
    1. Hauer K, Yardley L, Beyer N. Validation of the falls efficacy scale and falls efficacy scale international in geriatric patients with and without cognitive impairment: results of self-report and interview-based questionnaires. Gerontology. 2010;56(2):190–199. doi: 10.1159/000236027.
    1. Hauer KA, Kempen GI, Schwenk M. Validity and sensitivity to change of the falls efficacy scales international to assess fear of falling in older adults with and without cognitive impairment. Gerontology. 2011;57(5):462–472.
    1. Hilbe JM. Negative Binominal Regression. 2. Cambridge, UK: Cambridge University Press; 2011.
    1. Panel on Prevention of Falls in Older Persons AGS/BGS. Summary of the Updated American Geriatrics Society/British Geriatrics Society Clinical Practice Guideline for Prevention of Falls in Older Persons. J Am Geriatr Soc. 2011;59(1):148–57.
    1. Medical Research Council. A framework for development and evaluation of RCT's for complex interventions to improve health 2000. Internet communication: .
    1. Faes MC, Reelick MF, Esselink RA, Rikkert MG. Developing and evaluating complex healthcare interventions in geriatrics: the use of the medical research council framework exemplified on a complex fall prevention intervention. J Am Geriatr Soc. 2010;58(11):2212–2221. doi: 10.1111/j.1532-5415.2010.03108.x.
    1. Faes MC, Reelick MF, Joosten-Weyn Banningh LW, Gier M, Esselink RA, Olde Rikkert MG. Qualitative study on the impact of falling in frail older persons and family caregivers: foundations for an intervention to prevent falls. Aging Ment Health. 2010;14(7):834–842. doi: 10.1080/13607861003781825.
    1. Reelick MF, Faes MC, Esselink RA, Kessels RP, Olde Rikkert MG. How to perform a preplanned process evaluation for complex interventions in geriatric medicine: exemplified with the process evaluation of a complex falls-prevention program for community-dwelling frail older fallers. J Am Med Dir Assoc. 2011;12(5):331–336. doi: 10.1016/j.jamda.2011.01.006.
    1. Schwenk M, Lauenroth A, Stock C. Definitions and methods of measuring and reporting on injurious falls in randomised controlled fall prevention trials: a systematic review. BMC Med Res Methodol. 2012;12:50. doi: 10.1186/1471-2288-12-50.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa