Parkinson Disease Clinical Trial
— PASTAOfficial title:
Parkinson App SmarTphone Aimed to Improve Walking Ability and Reduce Fall (P.A.S.T.A.)
Gait impairments of patients with Parkinson's disease (PD) limit the independence in the daily activities and sensibly increase the risk of falls. New gait analysis methods, based on wearable inertial sensors, have been proposed to track the gait features during treatment and in real-life conditions. Gait training based on auditory cues as Rhythmical Auditory Stimulation (RAS) have preliminarily shown positive effects improving gait velocity, stride length, step cadence of walking in PD. In the current project, the research group will aim to develop a smartphone application (Parkinson App Smartphone Aimed: P.A.St.A.) integrated with sensors and RAS. In a second time, investigators will analyze the spatio-temporal gait parameters obtained by the wearable sensors and the sociodemographic and clinical data, thus generating a big data set, to improve the knowledge about current pharmacological therapies and rehabilitation.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2021 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Idiopathic Parkinson's disease diagnosed by a neurologist - Ability to sign informed consent Exclusion Criteria: - Inability to sign informed consent - Inability to fill out questionnaires (i.e. due to poor vision, inability to read, etc) - Presence of psychiatric diseases (episode or any form of psychosis, diagnosed by a psychiatrist in the last year). - Age under 18 yrs old |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Don Carlo Gnocchi Onlus | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus | Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Baker K, Rochester L, Nieuwboer A. The effect of cues on gait variability--reducing the attentional cost of walking in people with Parkinson's disease. Parkinsonism Relat Disord. 2008;14(4):314-20. Epub 2007 Nov 7. — View Citation
Cunnington R, Iansek R, Bradshaw JL, Phillips JG. Movement-related potentials in Parkinson's disease. Presence and predictability of temporal and spatial cues. Brain. 1995 Aug;118 ( Pt 4):935-50. — View Citation
del Olmo MF, Arias P, Furio MC, Pozo MA, Cudeiro J. Evaluation of the effect of training using auditory stimulation on rhythmic movement in Parkinsonian patients--a combined motor and [18F]-FDG PET study. Parkinsonism Relat Disord. 2006 Apr;12(3):155-64. Epub 2006 Feb 3. — View Citation
Ford MP, Malone LA, Nyikos I, Yelisetty R, Bickel CS. Gait training with progressive external auditory cueing in persons with Parkinson's disease. Arch Phys Med Rehabil. 2010 Aug;91(8):1255-61. doi: 10.1016/j.apmr.2010.04.012. — View Citation
Heiderscheit BC. Movement Variability as a Clinical Measure for Locomotion. Journal of Applied Biomechanics 16(4): 419-427, 2000.
Iosa M, Fusco A, Morone G, Paolucci S. Development and decline of upright gait stability. Front Aging Neurosci. 2014 Feb 5;6:14. doi: 10.3389/fnagi.2014.00014. eCollection 2014. Review. — View Citation
Iosa M, Fusco A, Morone G, Pratesi L, Coiro P, Venturiero V, De Angelis D, Bragoni M, Paolucci S. Assessment of upper-body dynamic stability during walking in patients with subacute stroke. J Rehabil Res Dev. 2012;49(3):439-50. — View Citation
Iosa M, Morelli D, Marro T, Paolucci S, Fusco A. Ability and stability of running and walking in children with cerebral palsy. Neuropediatrics. 2013 Jun;44(3):147-54. doi: 10.1055/s-0033-1336016. Epub 2013 Mar 13. — View Citation
Iosa M, Morelli D, Nisi E, Sorbara C, Negrini S, Gentili P, Paolucci S, Fusco A. Assessment of upper body accelerations in young adults with intellectual disabilities while walking, running, and dual-task running. Hum Mov Sci. 2014 Apr;34:187-95. doi: 10.1016/j.humov.2014.02.005. Epub 2014 Mar 11. — View Citation
Iosa M, Morone G, Fusco A, Marchetti F, Caltagirone C, Paolucci S, Peppe A. Loss of fractal gait harmony in Parkinson's Disease. Clin Neurophysiol. 2016 Feb;127(2):1540-1546. doi: 10.1016/j.clinph.2015.11.016. Epub 2015 Dec 2. — View Citation
Kestenbaum M, Fahn S. Safety of IPX066 , an extended release carbidopa-levodopa formulation, for the treatment of Parkinson's disease. Expert Opin Drug Saf. 2015 May;14(5):761-7. doi: 10.1517/14740338.2015.1015986. Epub 2015 Feb 19. Review. — View Citation
Manns PJ, Baldwin E. Ambulatory activity of stroke survivors: measurement options for dose, intensity, and variability of activity. Stroke. 2009 Mar;40(3):864-7. doi: 10.1161/STROKEAHA.108.531590. Epub 2009 Jan 15. — View Citation
Mileti I, Germanotta M, Di Sipio E, Imbimbo I, Pacilli A, Erra C, Petracca M, Rossi S, Del Prete Z, Bentivoglio AR, Padua L, Palermo E. Measuring Gait Quality in Parkinson's Disease through Real-Time Gait Phase Recognition. Sensors (Basel). 2018 Mar 20;18(3). pii: E919. doi: 10.3390/s18030919. — View Citation
Morris ME, Iansek R, Matyas TA, Summers JJ. Stride length regulation in Parkinson's disease. Normalization strategies and underlying mechanisms. Brain. 1996 Apr;119 ( Pt 2):551-68. — View Citation
Oung QW, Muthusamy H, Lee HL, Basah SN, Yaacob S, Sarillee M, Lee CH. Technologies for Assessment of Motor Disorders in Parkinson's Disease: A Review. Sensors (Basel). 2015 Aug 31;15(9):21710-45. doi: 10.3390/s150921710. Review. — View Citation
Ozminkowski RJ, Wells TS, Hawkins K, Bhattarai GR, Martel CW, Yeh CS. Big Data, Little Data, and Care Coordination for Medicare Beneficiaries with Medigap Coverage. Big Data. 2015 Jun;3(2):114-25. doi: 10.1089/big.2014.0034. — View Citation
Padua L, Pazzaglia C, Pareyson D, Schenone A, Aiello A, Fabrizi GM, Cavallaro T, Santoro L, Manganelli F, Gemignani F, Vitetta F, Quattrone A, Mazzeo A, Russo M, Vita G; CMT-TRIAAL Group. Novel outcome measures for Charcot-Marie-Tooth disease: validation and reliability of the 6-min walk test and StepWatch(™) Activity Monitor and identification of the walking features related to higher quality of life. Eur J Neurol. 2016 Aug;23(8):1343-50. doi: 10.1111/ene.13033. Epub 2016 May 10. — View Citation
Rochester L, Hetherington V, Jones D, Nieuwboer A, Willems AM, Kwakkel G, Van Wegen E. The effect of external rhythmic cues (auditory and visual) on walking during a functional task in homes of people with Parkinson's disease. Arch Phys Med Rehabil. 2005 May;86(5):999-1006. — View Citation
Rogers MW. Disorders of posture, balance, and gait in Parkinson's disease. Clin Geriatr Med. 1996 Nov;12(4):825-45. Review. — View Citation
Rubinstein TC, Giladi N, Hausdorff JM. The power of cueing to circumvent dopamine deficits: a review of physical therapy treatment of gait disturbances in Parkinson's disease. Mov Disord. 2002 Nov;17(6):1148-60. Review. — View Citation
Skidmore FM, Mackman CA, Pav B, Shulman LM, Garvan C, Macko RF, Heilman KM. Daily ambulatory activity levels in idiopathic Parkinson disease. J Rehabil Res Dev. 2008;45(9):1343-8. — View Citation
Taborri J, Palermo E, Rossi S, Cappa P. Gait Partitioning Methods: A Systematic Review. Sensors (Basel). 2016 Jan 6;16(1). pii: E66. doi: 10.3390/s16010066. Review. — View Citation
Trojaniello D, Ravaschio A, Hausdorff JM, Cereatti A. Comparative assessment of different methods for the estimation of gait temporal parameters using a single inertial sensor: application to elderly, post-stroke, Parkinson's disease and Huntington's disease subjects. Gait Posture. 2015 Sep;42(3):310-6. doi: 10.1016/j.gaitpost.2015.06.008. Epub 2015 Jun 25. — View Citation
van der Heeden JF, Marinus J, Martinez-Martin P, Rodriguez-Blazquez C, Geraedts VJ, van Hilten JJ. Postural instability and gait are associated with severity and prognosis of Parkinson disease. Neurology. 2016 Jun 14;86(24):2243-50. doi: 10.1212/WNL.0000000000002768. Epub 2016 May 13. — View Citation
Yogev G, Plotnik M, Peretz C, Giladi N, Hausdorff JM. Gait asymmetry in patients with Parkinson's disease and elderly fallers: when does the bilateral coordination of gait require attention? Exp Brain Res. 2007 Mar;177(3):336-46. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlations between inertial sensor-derived measures of motor function and clinician ratings during performance of the UPDRS part 3 and total exam at baseline | Features extracted from continuous accelerometer signals recorded during real life for fourteen days, will be correlated with each relevant component of the UPDRS part 3 and corresponding clinician ratings to quantify the relationship between these measures. | Fourteen days | |
Secondary | Time Up&Go | Time Up&Go is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. | Baseline |
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