Beck EN, Ehgoetz Martens KA, Almeida QJ Freezing of Gait in Parkinson's Disease: An Overload Problem? PLoS One. 2015 Dec 17;10(12):e0144986. doi: 10.1371/journal.pone.0144986. eCollection 2015.
Bloem BR, Grimbergen YA, Cramer M, Valkenburg VV "Stops walking when talking" does not predict falls in Parkinson's disease. Ann Neurol. 2000 Aug;48(2):268. doi: 10.1002/1531-8249(200008)48:23.0.co;2-4. No abstract available.
Bloem BR, Okun MS, Klein C Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
Chomiak T, Watts A, Meyer N, Pereira FV, Hu B A training approach to improve stepping automaticity while dual-tasking in Parkinson's disease: A prospective pilot study. Medicine (Baltimore). 2017 Feb;96(5):e5934. doi: 10.1097/MD.0000000000005934.
Dal Bello-Haas V, Klassen L, Sheppard MS, Metcalfe A Psychometric Properties of Activity, Self-Efficacy, and Quality-of-Life Measures in Individuals with Parkinson Disease. Physiother Can. 2011 Winter;63(1):47-57. doi: 10.3138/ptc.2009-08. Epub 2011 Jan 20.
Dincher A, Schwarz M, Wydra G Analysis of the Effects of Whole-Body Vibration in Parkinson Disease - Systematic Review and Meta-Analysis. PM R. 2019 Jun;11(6):640-653. doi: 10.1002/pmrj.12094. Epub 2019 May 6.
Farombi TH, Owolabi MO, Ogunniyi A Falls and Their Associated Risks in Parkinson's Disease Patients in Nigeria. J Mov Disord. 2016 Sep;9(3):160-5. doi: 10.14802/jmd.16011. Epub 2016 Sep 21.
Fok P, Farrell M, McMeeken J Prioritizing gait in dual-task conditions in people with Parkinson's. Hum Mov Sci. 2010 Oct;29(5):831-42. doi: 10.1016/j.humov.2010.06.005. Epub 2010 Aug 19.
Goncalves H, Moreira R, Rodrigues A, Santos C Finding Parameters around the Abdomen for a Vibrotactile System: Healthy and Patients with Parkinson's Disease. J Med Syst. 2018 Oct 13;42(11):232. doi: 10.1007/s10916-018-1087-2.
Hurst H, Bolton J Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
Isaacson S, O'Brien A, Lazaro JD, Ray A, Fluet G The JFK BIG study: the impact of LSVT BIG(R) on dual task walking and mobility in persons with Parkinson's disease. J Phys Ther Sci. 2018 Apr;30(4):636-641. doi: 10.1589/jpts.30.636. Epub 2018 Apr 20.
Jacobs JV, Nutt JG, Carlson-Kuhta P, Allen R, Horak FB Dual tasking during postural stepping responses increases falls but not freezing in people with Parkinson's disease. Parkinsonism Relat Disord. 2014 Jul;20(7):779-81. doi: 10.1016/j.parkreldis.2014.04.001. Epub 2014 Apr 14.
Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
Lajoie Y, Gallagher SP Predicting falls within the elderly community: comparison of postural sway, reaction time, the Berg balance scale and the Activities-specific Balance Confidence (ABC) scale for comparing fallers and non-fallers. Arch Gerontol Geriatr. 2004 Jan-Feb;38(1):11-26. doi: 10.1016/s0167-4943(03)00082-7.
Lamont RM, Morris ME, Menz HB, McGinley JL, Brauer SG Falls in people with Parkinson's disease: A prospective comparison of community and home-based falls. Gait Posture. 2017 Jun;55:62-67. doi: 10.1016/j.gaitpost.2017.04.005. Epub 2017 Apr 4.
Leddy AL, Crowner BE, Earhart GM Functional gait assessment and balance evaluation system test: reliability, validity, sensitivity, and specificity for identifying individuals with Parkinson disease who fall. Phys Ther. 2011 Jan;91(1):102-13. doi: 10.2522/ptj.20100113. Epub 2010 Nov 11.
Mak MK, Yu L, Hui-Chan CW The immediate effect of a novel audio-visual cueing strategy (simulated traffic lights) on dual-task walking in people with Parkinson's disease. Eur J Phys Rehabil Med. 2013 Apr;49(2):153-9. Epub 2013 Mar 13.
Mancini M, Smulders K, Harker G, Stuart S, Nutt JG Assessment of the ability of open- and closed-loop cueing to improve turning and freezing in people with Parkinson's disease. Sci Rep. 2018 Aug 24;8(1):12773. doi: 10.1038/s41598-018-31156-4.
Marchetti GF, Lin CC, Alghadir A, Whitney SL Responsiveness and minimal detectable change of the dynamic gait index and functional gait index in persons with balance and vestibular disorders. J Neurol Phys Ther. 2014 Apr;38(2):119-24. doi: 10.1097/NPT.0000000000000015.
Munoz-Hellin E, Cano-de-la-Cuerda R, Miangolarra-Page JC [Visual cues as a therapeutic tool in Parkinson's disease. A systematic review]. Rev Esp Geriatr Gerontol. 2013 Jul-Aug;48(4):190-7. doi: 10.1016/j.regg.2013.03.002. Epub 2013 Jun 2. Spanish.
Otis MJ, Ayena JC, Tremblay LE, Fortin PE, Menelas BA Use of an Enactive Insole for Reducing the Risk of Falling on Different Types of Soil Using Vibrotactile Cueing for the Elderly. PLoS One. 2016 Sep 7;11(9):e0162107. doi: 10.1371/journal.pone.0162107. eCollection 2016.
Park JK, Kim SJ Dual-Task-Based Drum Playing with Rhythmic Cueing on Motor and Attention Control in Patients with Parkinson's Disease: A Preliminary Randomized Study. Int J Environ Res Public Health. 2021 Sep 26;18(19):10095. doi: 10.3390/ijerph181910095.
Pereira MP, Gobbi LT, Almeida QJ Freezing of gait in Parkinson's disease: Evidence of sensory rather than attentional mechanisms through muscle vibration. Parkinsonism Relat Disord. 2016 Aug;29:78-82. doi: 10.1016/j.parkreldis.2016.05.021. Epub 2016 May 21.
Podsiadlo D, Richardson S The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Powell LE, Myers AM The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
Rochester L, Burn DJ, Woods G, Godwin J, Nieuwboer A Does auditory rhythmical cueing improve gait in people with Parkinson's disease and cognitive impairment? A feasibility study. Mov Disord. 2009 Apr 30;24(6):839-45. doi: 10.1002/mds.22400.
Rochester L, Rafferty D, Dotchin C, Msuya O, Minde V, Walker RW The effect of cueing therapy on single and dual-task gait in a drug naive population of people with Parkinson's disease in northern Tanzania. Mov Disord. 2010 May 15;25(7):906-11. doi: 10.1002/mds.22978.
Shribman S, Hasan H, Hadavi S, Giovannoni G, Noyce AJ The BRAIN test: a keyboard-tapping test to assess disability and clinical features of multiple sclerosis. J Neurol. 2018 Feb;265(2):285-290. doi: 10.1007/s00415-017-8690-x. Epub 2017 Dec 4.
Sim J, Lewis M The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
Skerrett TN, Moss-Morris R Fatigue and social impairment in multiple sclerosis: the role of patients' cognitive and behavioral responses to their symptoms. J Psychosom Res. 2006 Nov;61(5):587-93. doi: 10.1016/j.jpsychores.2006.04.018.
Stuart S, Mancini M Prefrontal Cortical Activation With Open and Closed-Loop Tactile Cueing When Walking and Turning in Parkinson Disease: A Pilot Study. J Neurol Phys Ther. 2020 Apr;44(2):121-131. doi: 10.1097/NPT.0000000000000286.
Tan XS, Pierres F, Dallman-Porter A, Hardie-Brown W, Kwon KY Focused Vibrotactile Stimulation with Cueing Effect on Freezing of Gait in Parkinson's Disease: Two Case Reports. J Mov Disord. 2021 Sep;14(3):236-238. doi: 10.14802/jmd.21076. Epub 2021 Sep 8.
Volpe D, Giantin MG, Fasano A A wearable proprioceptive stabilizer (Equistasi(R)) for rehabilitation of postural instability in Parkinson's disease: a phase II randomized double-blind, double-dummy, controlled study. PLoS One. 2014 Nov 17;9(11):e112065. doi: 10.1371/journal.pone.0112065. eCollection 2014.
Wilhelm A, Riedl T, Paumann C, Janssen J Exploring a New Cueing Device in People Who Experience Freezing of Gait: Acceptance of a Study Design. Parkinsons Dis. 2022 Dec 7;2022:1631169. doi: 10.1155/2022/1631169. eCollection 2022.
Wrisley DM, Kumar NA Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1.
Yang Y, Wang Y, Zhou Y, Chen C, Xing D, Wang C Validity of the Functional Gait Assessment in patients with Parkinson disease: construct, concurrent, and predictive validity. Phys Ther. 2014 Mar;94(3):392-400. doi: 10.2522/ptj.20130019. Epub 2013 Oct 24.
Yang Y, Wang Y, Zhou Y, Chen C, Xing D Reliability of functional gait assessment in patients with Parkinson disease: Interrater and intrarater reliability and internal consistency. Medicine (Baltimore). 2016 Aug;95(34):e4545. doi: 10.1097/MD.0000000000004545.
Zigmond AS, Snaith RP The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
The Use of the CUE1 Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.