- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02438124
Optimalisering af rytmisk auditiv stimulering til gangforbedring ved Parkinsons sygdom - BeatPark-undersøgelse (BeatPark)
Optimalisering af rytmisk auditiv stimulering til gangforbedring ved Parkinsons
De gavnlige virkninger af rytmisk auditiv stimulation (RAS) på spatio-temporale gangkarakteristika ved Parkinsons sygdom (PD) er attesteret af klinisk forskning.
Ikke desto mindre er det stadig uklart, hvilke auditive informationsparametre (dvs. kompleksitet, tidsmæssig regelmæssighed eller tilpasningsevne til gang) maksimerer effektiviteten af RAS.
Formål: At evaluere de gavnlige virkninger af RAS på spatio-temporale gangkarakteristika hos PD-patienter med gangforstyrrelser i henhold til:
- RAS-kompleksitet (dvs. metronom, amplitudemoduleret støj, musik)
- RAS-variabilitet (dvs. fast, tilfældig, semi-tilfældig)
- RAS tilpasset i realtid til gangart
Variabilitetsundersøgelse:
At studere virkningen af RAS-variabilitet (dvs. fast, tilfældig, semi-tilfældig) hos 20 PD-patienter og 20 raske kontroller på spatio-temporale gangkarakteristika med metronom, amplitudestøj og musik.
Tilpasningsevneundersøgelse For at studere virkningen af RAS-tilpasningsevne (dvs. fast, tilfældig, tilpasset i realtid til gang) hos 20 PD-patienter og 20 raske kontroller på spatio-temporale gangkarakteristika med metronom, amplitudestøj og musik.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Montpellier, Frankrig, 34070
- Rekruttering
- Service de neurologie de la Clinique Beau Soleil
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Kontakt:
- Cochen De Cock Valérie, MD
- Telefonnummer: 06 09 04 35 05
- E-mail: valerie.cochen@gmail.com
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Montpellier, Frankrig, 34235
- Rekruttering
- CIC
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Kontakt:
- Florence Galtier, Doctor
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Kontakt:
- Valérie Cochen de cock, MD
- Telefonnummer: 06 09 04 35 05
- E-mail: valerie.cochen@gmail.com
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Montpellier, Frankrig, 34235
- Rekruttering
- Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du
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Kontakt:
- Valérie Cochen de cock, MD
- Telefonnummer: 06 09 04 35 05
- E-mail: valerie.cochen@gmail.com
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Kontakt:
- Sophie Bayard
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- 18 år
- at kunne forstå undersøgelsens mål og at acceptere at deltage
- at have underskrevet samtykkeerklæringen
- at blive registreret i socialsikringssystemet
- at nå diagnosekriterierne for idiopatisk PD (Queen Square Brain Bank)
- gangforstyrrelse klinisk observerbar
Ekskluderingskriterier:
- gravid eller ammende kvinde
- høj sandsynlighed for manglende overholdelse
- kuratorer, forfatterskab eller rådgivere til fuld alder Specifikke eksklusionskriterier for PD-patienter
- kliniske tegn på Parkinsons syndrom
- Mini mental tilstandsundersøgelse < 24/30 Specifikke udelukkelseskriterier for kontroller
- neurologisk sygdom
- gangforstyrrelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Patient
Patient med Parkinsons sygdom med gangtest og neuropsykologisk udredning
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Forsøgspersonerne indsendes i én hørestimulus, mens de gennemfører en gangtest
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Eksperimentel: Kontrol
normal kontrol med gangtest og neuropsykologisk udredning
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Forsøgspersonerne indsendes i én hørestimulus, mens de gennemfører en gangtest
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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ganghastighed
Tidsramme: 2 dage
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evaluering af ganghastighed mellem de forskellige forhold
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2 dage
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
spatio-temporale gangkarakteristika
Tidsramme: 2 dage
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evaluering af andre gangparametre mellem de forskellige forhold
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2 dage
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Valérie Cochen De Cock, MD, University Hospital, Montpellier
Publikationer og nyttige links
Generelle publikationer
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- Arias P, Cudeiro J. Effects of rhythmic sensory stimulation (auditory, visual) on gait in Parkinson's disease patients. Exp Brain Res. 2008 Apr;186(4):589-601. doi: 10.1007/s00221-007-1263-y. Epub 2008 Jan 23.
- Arias P, Cudeiro J. Effect of rhythmic auditory stimulation on gait in Parkinsonian patients with and without freezing of gait. PLoS One. 2010 Mar 22;5(3):e9675. doi: 10.1371/journal.pone.0009675.
- Blin O, Ferrandez AM, Pailhous J, Serratrice G. Dopa-sensitive and dopa-resistant gait parameters in Parkinson's disease. J Neurol Sci. 1991 May;103(1):51-4. doi: 10.1016/0022-510x(91)90283-d.
- Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. doi: 10.1002/mds.20115.
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- Gibb WR, Lees AJ. The relevance of the Lewy body to the pathogenesis of idiopathic Parkinson's disease. J Neurol Neurosurg Psychiatry. 1988 Jun;51(6):745-52. doi: 10.1136/jnnp.51.6.745.
- Godefroy O, Brigitte A, Philippe A, Mira DH, Olivier G, Didier le G, Rose-Marie M, Thierry M, Chrystele M, Blandine P, Bernard P, Philippe R; Groupe de Reflexion sur L'Evaluation des Fonctions EXecutives. [Frontal dysexecutive syndromes]. Rev Neurol (Paris). 2004 Oct;160(10):899-909. doi: 10.1016/s0035-3787(04)71071-1. French.
- Hausdorff JM. Gait dynamics in Parkinson's disease: common and distinct behavior among stride length, gait variability, and fractal-like scaling. Chaos. 2009 Jun;19(2):026113. doi: 10.1063/1.3147408.
- Hove MJ, Suzuki K, Uchitomi H, Orimo S, Miyake Y. Interactive rhythmic auditory stimulation reinstates natural 1/f timing in gait of Parkinson's patients. PLoS One. 2012;7(3):e32600. doi: 10.1371/journal.pone.0032600. Epub 2012 Mar 2.
- Howe TE, Lovgreen B, Cody FW, Ashton VJ, Oldham JA. Auditory cues can modify the gait of persons with early-stage Parkinson's disease: a method for enhancing parkinsonian walking performance? Clin Rehabil. 2003 Jul;17(4):363-7. doi: 10.1191/0269215503cr621oa.
- Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.
- Judge JO, Davis RB 3rd, Ounpuu S. Step length reductions in advanced age: the role of ankle and hip kinetics. J Gerontol A Biol Sci Med Sci. 1996 Nov;51(6):M303-12. doi: 10.1093/gerona/51a.6.m303.
- Kerr GK, Worringham CJ, Cole MH, Lacherez PF, Wood JM, Silburn PA. Predictors of future falls in Parkinson disease. Neurology. 2010 Jul 13;75(2):116-24. doi: 10.1212/WNL.0b013e3181e7b688. Epub 2010 Jun 23.
- Kirschner S, Tomasello M. Joint drumming: social context facilitates synchronization in preschool children. J Exp Child Psychol. 2009 Mar;102(3):299-314. doi: 10.1016/j.jecp.2008.07.005. Epub 2008 Sep 12.
- Lehman DA, Toole T, Lofald D, Hirsch MA. Training with verbal instructional cues results in near-term improvement of gait in people with Parkinson disease. J Neurol Phys Ther. 2005 Mar;29(1):2-8. doi: 10.1097/01.npt.0000282256.36208.cf.
- Lim I, van Wegen E, de Goede C, Deutekom M, Nieuwboer A, Willems A, Jones D, Rochester L, Kwakkel G. Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review. Clin Rehabil. 2005 Oct;19(7):695-713. doi: 10.1191/0269215505cr906oa.
- Marchese R, Diverio M, Zucchi F, Lentino C, Abbruzzese G. The role of sensory cues in the rehabilitation of parkinsonian patients: a comparison of two physical therapy protocols. Mov Disord. 2000 Sep;15(5):879-83. doi: 10.1002/1531-8257(200009)15:53.0.co;2-9.
- Marmelat V, Delignieres D. Strong anticipation: complexity matching in interpersonal coordination. Exp Brain Res. 2012 Oct;222(1-2):137-48. doi: 10.1007/s00221-012-3202-9. Epub 2012 Aug 4.
- McIntosh GC, Brown SH, Rice RR, Thaut MH. Rhythmic auditory-motor facilitation of gait patterns in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Jan;62(1):22-6. doi: 10.1136/jnnp.62.1.22.
- McIntosh, G.C., Rice, R.R., Hurt, C.P., and Thaut, M.H. (1998). Long-term training effects of rhythmic auditory stimulation on gait in patients with Parkinson's disease. Mov. Disord. Off. J. Mov. Disord. Soc. 13 (supple2), 212.
- 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.
- Nieuwboer A. Cueing for freezing of gait in patients with Parkinson's disease: a rehabilitation perspective. Mov Disord. 2008;23 Suppl 2:S475-81. doi: 10.1002/mds.21978. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40.
- 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.
- Nombela C, Hughes LE, Owen AM, Grahn JA. Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3.
- del Olmo MF, Cudeiro J. Temporal variability of gait in Parkinson disease: effects of a rehabilitation programme based on rhythmic sound cues. Parkinsonism Relat Disord. 2005 Jan;11(1):25-33. doi: 10.1016/j.parkreldis.2004.09.002. Epub 2004 Dec 9.
- Post B, Muslimovic D, van Geloven N, Speelman JD, Schmand B, de Haan RJ; CARPA-study group. Progression and prognostic factors of motor impairment, disability and quality of life in newly diagnosed Parkinson's disease. Mov Disord. 2011 Feb 15;26(3):449-56. doi: 10.1002/mds.23467. Epub 2011 Feb 10.
- Rascol O, Goetz C, Koller W, Poewe W, Sampaio C. Treatment interventions for Parkinson's disease: an evidence based assessment. Lancet. 2002 May 4;359(9317):1589-98. doi: 10.1016/S0140-6736(02)08520-3.
- Repp BH. Sensorimotor synchronization: a review of the tapping literature. Psychon Bull Rev. 2005 Dec;12(6):969-92. doi: 10.3758/bf03206433.
- Repp BH, Su YH. Sensorimotor synchronization: a review of recent research (2006-2012). Psychon Bull Rev. 2013 Jun;20(3):403-52. doi: 10.3758/s13423-012-0371-2.
- Rizzolatti G, Fogassi L, Gallese V. Neurophysiological mechanisms underlying the understanding and imitation of action. Nat Rev Neurosci. 2001 Sep;2(9):661-70. doi: 10.1038/35090060. No abstract available.
- Schaafsma JD, Giladi N, Balash Y, Bartels AL, Gurevich T, Hausdorff JM. Gait dynamics in Parkinson's disease: relationship to Parkinsonian features, falls and response to levodopa. J Neurol Sci. 2003 Aug 15;212(1-2):47-53. doi: 10.1016/s0022-510x(03)00104-7.
- Sowinski J, Dalla Bella S. Poor synchronization to the beat may result from deficient auditory-motor mapping. Neuropsychologia. 2013 Aug;51(10):1952-63. doi: 10.1016/j.neuropsychologia.2013.06.027. Epub 2013 Jul 6.
- 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.
- Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Mov Disord. 1996 Mar;11(2):193-200. doi: 10.1002/mds.870110213.
- Thaut MH, McIntosh KW, McIntosh GC, Hoemberg V. Auditory rhythmicity enhances movement and speech motor control in patients with Parkinson's disease. Funct Neurol. 2001 Apr-Jun;16(2):163-72. No abstract available.
- Vu TC, Nutt JG, Holford NH. Progression of motor and nonmotor features of Parkinson's disease and their response to treatment. Br J Clin Pharmacol. 2012 Aug;74(2):267-83. doi: 10.1111/j.1365-2125.2012.04192.x.
- Willems AM, Nieuwboer A, Chavret F, Desloovere K, Dom R, Rochester L, Jones D, Kwakkel G, Van Wegen E. The use of rhythmic auditory cues to influence gait in patients with Parkinson's disease, the differential effect for freezers and non-freezers, an explorative study. Disabil Rehabil. 2006 Jun 15;28(11):721-8. doi: 10.1080/09638280500386569.
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Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9193-2
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