Improving Walking Ability in Parkinson Disease

NCT03921697 | Unknown

• 1 other identifier: GR-2016-02362879
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Technological Rehabilitation; Digital Inclusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time Up&Go

  Baseline

Study Arms (1)

Parkinson Disease Patients

Patients with PD will be recruited at Fondazione Policlinico Universitario Gemelli and Fondazione Don Gnocchi ONLUS in Rome. All included patients will be affected by idiopathic PD. Clinical data will be acquired by a trained neurologist. We will remotely monitor 300 patients through wearable sensors. Subjects will be instructed to wear the sensor for 14 consecutive days.

Device: Werable sensors

Interventions

Werable sensors DEVICE

Parkinson Disease Patients monitored by werable sensors

Parkinson Disease Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD patients will be enrolled among outpatients of the Movement Disorders Unit of the Gemelli University Hospital and outpatients of the Fondazione Don Carlo Gnocchi Onlus.

You may qualify if:

• Idiopathic Parkinson's disease diagnosed by a neurologist
• Ability to sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus

Roma, 00166, Italy

RECRUITING

Related Publications (25)

• 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. doi: 10.1002/mds.10259.

  PMID: 12465051 BACKGROUND

• Rogers MW. Disorders of posture, balance, and gait in Parkinson's disease. Clin Geriatr Med. 1996 Nov;12(4):825-45.

  PMID: 8890118 BACKGROUND

• 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. doi: 10.1007/s00221-006-0676-3.

  PMID: 16972073 BACKGROUND

• Heiderscheit BC. Movement Variability as a Clinical Measure for Locomotion. Journal of Applied Biomechanics 16(4): 419-427, 2000.

  BACKGROUND

• 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.

  PMID: 27178702 BACKGROUND

• 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. doi: 10.1093/brain/118.4.935.

  PMID: 7655889 BACKGROUND

• 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. doi: 10.1093/brain/119.2.551.

  PMID: 8800948 BACKGROUND

• 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.

  PMID: 25697185 BACKGROUND

• 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.

  PMID: 26404288 BACKGROUND

• 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. doi: 10.1016/j.apmr.2004.10.040.

  PMID: 15895348 BACKGROUND

• 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. doi: 10.1016/j.parkreldis.2005.11.002. Epub 2006 Feb 3.

  PMID: 16459124 BACKGROUND

• 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.

  PMID: 20684907 BACKGROUND

• 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. doi: 10.1016/j.parkreldis.2007.09.008. Epub 2007 Nov 7.

  PMID: 17988925 BACKGROUND

• Taborri J, Palermo E, Rossi S, Cappa P. Gait Partitioning Methods: A Systematic Review. Sensors (Basel). 2016 Jan 6;16(1):66. doi: 10.3390/s16010066.

  PMID: 26751449 BACKGROUND

• 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.

  PMID: 26163348 BACKGROUND

• 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.

  PMID: 27447434 BACKGROUND

• 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. doi: 10.1682/jrrd.2011.03.0057.

  PMID: 22773202 BACKGROUND

• 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.

  PMID: 24550829 BACKGROUND

• 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.

  PMID: 23487325 BACKGROUND

• 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.

  PMID: 26679417 BACKGROUND

• 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.

  PMID: 24630612 BACKGROUND

• 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.

  PMID: 19150867 BACKGROUND

• 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.

  PMID: 19319758 BACKGROUND

• 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.

  PMID: 27160471 BACKGROUND

• 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):919. doi: 10.3390/s18030919.

  PMID: 29558410 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Augusto Fusco, M.D.; Ph.D.

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella Imbimbo, M.S.

CONTACT

+390633086414; iimbimbo@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; M.D.; Ph.D.

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 19, 2019
• Study Start: April 23, 2019
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2021
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)