Observational Study to Observe Variations of Gait Parameters in Patients With Neuromuscular Diseases
NCT ID: NCT06666816
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2017-10-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group with neuromuscular disease
inapplicable
inapplicable
Control Group
inapplicable
inapplicable
Interventions
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inapplicable
inapplicable
Eligibility Criteria
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Inclusion Criteria
* independent walking, even with assistance;
Exclusion Criteria
* Chronic respiratory failure: forced vital capacity (FVC) \< 40%; more than 5% of nocturnal time spent with peripheral oxygen saturation levels \< 90.
18 Years
75 Years
ALL
Yes
Sponsors
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IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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Scientific Institute IRCCS E. Medea - Sede di Bosisio Parini
Bosisio Parini, Lecco, Italy
Scientific Institute IRCCS E. Medea - Polo di Conegliano
Conegliano, Treviso, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.
O'Hagen JM, Glanzman AM, McDermott MP, Ryan PA, Flickinger J, Quigley J, Riley S, Sanborn E, Irvine C, Martens WB, Annis C, Tawil R, Oskoui M, Darras BT, Finkel RS, De Vivo DC. An expanded version of the Hammersmith Functional Motor Scale for SMA II and III patients. Neuromuscul Disord. 2007 Oct;17(9-10):693-7. doi: 10.1016/j.nmd.2007.05.009. Epub 2007 Jul 19.
Berard C, Payan C, Hodgkinson I, Fermanian J; MFM Collaborative Study Group. A motor function measure for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005 Jul;15(7):463-70. doi: 10.1016/j.nmd.2005.03.004.
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.
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
Erratum: ATS Statement: Guidelines for the Six-Minute Walk Test. Am J Respir Crit Care Med. 2016 May 15;193(10):1185. doi: 10.1164/rccm.19310erratum. No abstract available.
Mikolaizak AS, Rochester L, Maetzler W, Sharrack B, Demeyer H, Mazza C, Caulfield B, Garcia-Aymerich J, Vereijken B, Arnera V, Miller R, Piraino P, Ammour N, Gordon MF, Troosters T, Yarnall AJ, Alcock L, Gassner H, Winkler J, Klucken J, Schlenstedt C, Watz H, Kirsten AM, Vogiatzis I, Chynkiamis N, Hume E, Megaritis D, Nieuwboer A, Ginis P, Buckley E, Brittain G, Comi G, Leocani L, Helbostad JL, Johnsen LG, Taraldsen K, Blain H, Driss V, Frei A, Puhan MA, Polhemus A, Bosch de Basea M, Gimeno E, Hopkinson NS, Buttery SC, Hausdorff JM, Mirelman A, Evers J, Neatrour I, Singleton D, Schwickert L, Becker C, Jansen CP; clinical validation study (WP4) on behalf of Mobilise-D consortium. Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement-the Mobilise-D study protocol. PLoS One. 2022 Oct 6;17(10):e0269615. doi: 10.1371/journal.pone.0269615. eCollection 2022.
Mazza C, Alcock L, Aminian K, Becker C, Bertuletti S, Bonci T, Brown P, Brozgol M, Buckley E, Carsin AE, Caruso M, Caulfield B, Cereatti A, Chiari L, Chynkiamis N, Ciravegna F, Del Din S, Eskofier B, Evers J, Garcia Aymerich J, Gazit E, Hansen C, Hausdorff JM, Helbostad JL, Hiden H, Hume E, Paraschiv-Ionescu A, Ireson N, Keogh A, Kirk C, Kluge F, Koch S, Kuderle A, Lanfranchi V, Maetzler W, Mico-Amigo ME, Mueller A, Neatrour I, Niessen M, Palmerini L, Pluimgraaff L, Reggi L, Salis F, Schwickert L, Scott K, Sharrack B, Sillen H, Singleton D, Soltani A, Taraldsen K, Ullrich M, Van Gelder L, Vereijken B, Vogiatzis I, Warmerdam E, Yarnall A, Rochester L. Technical validation of real-world monitoring of gait: a multicentric observational study. BMJ Open. 2021 Dec 2;11(12):e050785. doi: 10.1136/bmjopen-2021-050785.
Storm FA, Nair KPS, Clarke AJ, Van der Meulen JM, Mazza C. Free-living and laboratory gait characteristics in patients with multiple sclerosis. PLoS One. 2018 May 1;13(5):e0196463. doi: 10.1371/journal.pone.0196463. eCollection 2018.
Goldhahn J. Need for Digital Biomarkers in Musculoskeletal Trials. Digit Biomark. 2017 Aug 17;1(1):82-86. doi: 10.1159/000479753. eCollection 2017 Sep-Dec.
Stull DE, Leidy NK, Parasuraman B, Chassany O. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr Med Res Opin. 2009 Apr;25(4):929-42. doi: 10.1185/03007990902774765.
Leale I, Giustino V, Trapani P, Alonge P, Rini N, Cutro I, Leone O, Torrente A, Lupica A, Palma A, Roccella M, Brighina F, Di Stefano V, Battaglia G. Physical Activity in Patients with Neuromuscular Disease Three Years after COVID-19, a Longitudinal Survey: The After-Effects of the Quarantine and the Benefits of a Return to a Healthier Life-Style. J Clin Med. 2024 Jan 3;13(1):265. doi: 10.3390/jcm13010265.
Kennedy RA, Carroll K, McGinley JL, Paterson KL. Walking and weakness in children: a narrative review of gait and functional ambulation in paediatric neuromuscular disease. J Foot Ankle Res. 2020 Mar 2;13(1):10. doi: 10.1186/s13047-020-0378-2.
Retory Y, David P, Niedzialkowski P, de Picciotto C, Bonay M, Petitjean M. Gait Monitoring and Walk Distance Estimation With an Accelerometer During 6-Minute Walk Test. Respir Care. 2019 Aug;64(8):923-930. doi: 10.4187/respcare.06144. Epub 2019 Jun 18.
Ghislieri M, Gastaldi L, Pastorelli S, Tadano S, Agostini V. Wearable Inertial Sensors to Assess Standing Balance: A Systematic Review. Sensors (Basel). 2019 Sep 20;19(19):4075. doi: 10.3390/s19194075.
Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
Other Identifiers
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RC 2024-2026 to E. Biffi
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GIP1112
Identifier Type: -
Identifier Source: org_study_id
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