Clinical trial NCT06174948 - References

Dystonia — The Use of the CUE1 in People With Parkinson's Disease and Related Disorders

Citation(s)

•   Akram N, Li H, Ben-Joseph A, Budu C, Gallagher DA, Bestwick JP, Schrag A, Noyce AJ, Simonet C
  Developing and assessing a new web-based tapping test for measuring distal movement in Parkinson's disease: a Distal Finger Tapping test. Sci Rep. 2022 Jan 10;12(1):386. doi: 10.1038/s41598-021-03563-7.
•   Basta D, Rossi-Izquierdo M, Soto-Varela A, Greters ME, Bittar RS, Steinhagen-Thiessen E, Eckardt R, Harada T, Goto F, Ogawa K, Ernst A
  Efficacy of a vibrotactile neurofeedback training in stance and gait conditions for the treatment of balance deficits: a double-blind, placebo-controlled multicenter study. Otol Neurotol. 2011 Dec;32(9):1492-9. doi: 10.1097/MAO.0b013e31823827ec.
•   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.
•   Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ
  The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
•   Chaudhuri KR, Schrag A, Weintraub D, Rizos A, Rodriguez-Blazquez C, Mamikonyan E, Martinez-Martin P
  The movement disorder society nonmotor rating scale: Initial validation study. Mov Disord. 2020 Jan;35(1):116-133. doi: 10.1002/mds.27862. Epub 2019 Sep 30. Erratum In: Mov Disord. 2020 Oct;35(10):1892.
•   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.
•   Conte A, Khan N, Defazio G, Rothwell JC, Berardelli A
  Pathophysiology of somatosensory abnormalities in Parkinson disease. Nat Rev Neurol. 2013 Dec;9(12):687-97. doi: 10.1038/nrneurol.2013.224. Epub 2013 Nov 12.
•   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.
•   Dorsey ER, Sherer T, Okun MS, Bloem BR
  The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
•   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.
•   Giladi N, Shabtai H, Simon ES, Biran S, Tal J, Korczyn AD
  Construction of freezing of gait questionnaire for patients with Parkinsonism. Parkinsonism Relat Disord. 2000 Jul 1;6(3):165-170. doi: 10.1016/s1353-8020(99)00062-0.
•   Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force
  Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
•   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.
•   Grosset D, Taurah L, Burn DJ, MacMahon D, Forbes A, Turner K, Bowron A, Walker R, Findley L, Foster O, Patel K, Clough C, Castleton B, Smith S, Carey G, Murphy T, Hill J, Brechany U, McGee P, Reading S, Brand G, Kelly L, Breen K, Ford S, Baker M, Williams A, Hearne J, Qizilbash N, Chaudhuri KR
  A multicentre longitudinal observational study of changes in self reported health status in people with Parkinson's disease left untreated at diagnosis. J Neurol Neurosurg Psychiatry. 2007 May;78(5):465-9. doi: 10.1136/jnnp.2006.098327. Epub 2006 Nov 10.
•   Hasan H, Burrows M, Athauda DS, Hellman B, James B, Warner T, Foltynie T, Giovannoni G, Lees AJ, Noyce AJ
  The BRadykinesia Akinesia INcoordination (BRAIN) Tap Test: Capturing the Sequence Effect. Mov Disord Clin Pract. 2019 Jun 25;6(6):462-469. doi: 10.1002/mdc3.12798. eCollection 2019 Jul.
•   Heremans E, Nackaerts E, Vervoort G, Broeder S, Swinnen SP, Nieuwboer A
  Impaired Retention of Motor Learning of Writing Skills in Patients with Parkinson's Disease with Freezing of Gait. PLoS One. 2016 Feb 10;11(2):e0148933. doi: 10.1371/journal.pone.0148933. eCollection 2016.
•   Hoops S, Nazem S, Siderowf AD, Duda JE, Xie SX, Stern MB, Weintraub D
  Validity of the MoCA and MMSE in the detection of MCI and dementia in Parkinson disease. Neurology. 2009 Nov 24;73(21):1738-45. doi: 10.1212/WNL.0b013e3181c34b47.
•   Huber M, Knottnerus JA, Green L, van der Horst H, Jadad AR, Kromhout D, Leonard B, Lorig K, Loureiro MI, van der Meer JW, Schnabel P, Smith R, van Weel C, Smid H
  How should we define health? BMJ. 2011 Jul 26;343:d4163. doi: 10.1136/bmj.d4163. No abstract available.
•   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.
•   Killane I, Fearon C, Newman L, McDonnell C, Waechter SM, Sons K, Lynch T, Reilly RB
  Dual Motor-Cognitive Virtual Reality Training Impacts Dual-Task Performance in Freezing of Gait. IEEE J Biomed Health Inform. 2015 Nov;19(6):1855-61. doi: 10.1109/JBHI.2015.2479625. Epub 2015 Sep 17.
•   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.
•   Muslimovic D, Post B, Speelman JD, Schmand B, de Haan RJ; CARPA Study Group
  Determinants of disability and quality of life in mild to moderate Parkinson disease. Neurology. 2008 Jun 3;70(23):2241-7. doi: 10.1212/01.wnl.0000313835.33830.80.
•   Muthukrishnan N, Abbas JJ, Shill HA, Krishnamurthi N
  Cueing Paradigms to Improve Gait and Posture in Parkinson's Disease: A Narrative Review. Sensors (Basel). 2019 Dec 11;19(24):5468. doi: 10.3390/s19245468.
•   Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H
  The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
•   Nieuwboer A, Kwakkel G, Rochester L, Jones D, van Wegen E, Willems AM, Chavret F, Hetherington V, Baker K, Lim I
  Cueing training in the home improves gait-related mobility in Parkinson's disease: the RESCUE trial. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):134-40. doi: 10.1136/jnnp.200X.097923. Erratum In: J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1414. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):126.
•   Noyce AJ, Nagy A, Acharya S, Hadavi S, Bestwick JP, Fearnley J, Lees AJ, Giovannoni G
  Bradykinesia-akinesia incoordination test: validating an online keyboard test of upper limb function. PLoS One. 2014 Apr 29;9(4):e96260. doi: 10.1371/journal.pone.0096260. eCollection 2014. Erratum In: PLoS One. 2014;9(8):e105488.
•   Nutt JG, Bloem BR, Giladi N, Hallett M, Horak FB, Nieuwboer A
  Freezing of gait: moving forward on a mysterious clinical phenomenon. Lancet Neurol. 2011 Aug;10(8):734-44. doi: 10.1016/S1474-4422(11)70143-0.
•   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.
•   Pfeifer KJ, Kromer JA, Cook AJ, Hornbeck T, Lim EA, Mortimer BJP, Fogarty AS, Han SS, Dhall R, Halpern CH, Tass PA
  Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. Front Physiol. 2021 Apr 6;12:624317. doi: 10.3389/fphys.2021.624317. eCollection 2021.
•   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.
•   Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G
  MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
•   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.
•   Redgrave P, Rodriguez M, Smith Y, Rodriguez-Oroz MC, Lehericy S, Bergman H, Agid Y, DeLong MR, Obeso JA
  Goal-directed and habitual control in the basal ganglia: implications for Parkinson's disease. Nat Rev Neurosci. 2010 Nov;11(11):760-72. doi: 10.1038/nrn2915. Epub 2010 Oct 14.
•   Rochester L, Baker K, Hetherington V, Jones D, Willems AM, Kwakkel G, Van Wegen E, Lim I, Nieuwboer A
  Evidence for motor learning in Parkinson's disease: acquisition, automaticity and retention of cued gait performance after training with external rhythmical cues. Brain Res. 2010 Mar 10;1319:103-11. doi: 10.1016/j.brainres.2010.01.001. Epub 2010 Jan 11.
•   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, Nieuwboer A, Baker K, Hetherington V, Willems AM, Chavret F, Kwakkel G, Van Wegen E, Lim I, Jones D
  The attentional cost of external rhythmical cues and their impact on gait in Parkinson's disease: effect of cue modality and task complexity. J Neural Transm (Vienna). 2007;114(10):1243-8. doi: 10.1007/s00702-007-0756-y. Epub 2007 Jun 28.
•   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.
•   Spaulding SJ, Barber B, Colby M, Cormack B, Mick T, Jenkins ME
  Cueing and gait improvement among people with Parkinson's disease: a meta-analysis. Arch Phys Med Rehabil. 2013 Mar;94(3):562-70. doi: 10.1016/j.apmr.2012.10.026. Epub 2012 Nov 2.
•   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.
•   van Wegen E, de Goede C, Lim I, Rietberg M, Nieuwboer A, Willems A, Jones D, Rochester L, Hetherington V, Berendse H, Zijlmans J, Wolters E, Kwakkel G
  The effect of rhythmic somatosensory cueing on gait in patients with Parkinson's disease. J Neurol Sci. 2006 Oct 25;248(1-2):210-4. doi: 10.1016/j.jns.2006.05.034. Epub 2006 Jun 14.
•   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.
•   Wagle Shukla A, Ounpraseuth S, Okun MS, Gray V, Schwankhaus J, Metzer WS
  Micrographia and related deficits in Parkinson's disease: a cross-sectional study. BMJ Open. 2012 Jun 25;2(3):e000628. doi: 10.1136/bmjopen-2011-000628. Print 2012.
•   Weir S, Samnaliev M, Kuo TC, Tierney TS, Walleser Autiero S, Taylor RS, Schrag A
  Short- and long-term cost and utilization of health care resources in Parkinson's disease in the UK. Mov Disord. 2018 Jul;33(6):974-981. doi: 10.1002/mds.27302. Epub 2018 Mar 30.
•   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.
•   Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL
  Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.
•   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

Details for clinical trial NCT06174948