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| ID | Type | Description | Link |
|---|---|---|---|
| RC 2024-2026 to E. Biffi | Other Grant/Funding Number | Italian Ministry of Health |
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This study has the general objective of observing walking parameters during a clinical test to objectively estimate fatigue in patients with neuromuscular diseases. Furthermore, the investigators want to evaluate the feasibility of collecting physical activity in daily life conditions during a one-week monitoring period using a wearable sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with neuromuscular disease |
| ||
| Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inapplicable | Other | inapplicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation in walking speed during a 6-minutes walking test | Variation in walking speed calculated as difference between the first and the final minute of the a 6-minutes walking test | Baseline |
| Subjective fatigue | Evaluation of subjective fatigue using the Fatigue Severity Scale (FSS). The minimum value is 0, the maximum is 63. Higher scores mean worse outcome. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical progression of the neuromuscular disease | Progression of the neuromuscular disease using the Motor Function Measure-32 (MFM-32); the minimum score is 0, the maximum score is 100. Higher values mean better outcome. | Baseline |
| Clinical progression of the neuromuscular disease |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the activity monitoring device during daily life | Acceptability of the device during activity monitoring in daily life using the Comfort Rating Scale (CRS). Minimum value is 0, maximum value is 20. Higher values mean lower acceptability. | Baseline |
| User friendliness of the activity monitoring device during daily life |
Inclusion Criteria:
Exclusion Criteria:
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Potentially eligible participants will be selected from clinical databases of IRCCS Medea
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio A Storm, PhD | Contact | +39031877111 | fabio.storm@lanostrafamiglia.it | |
| Emilia Biffi, PhD | Contact | +39031877111 | emilia.biffi@lanostrafamiglia.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Institute IRCCS E. Medea - Sede di Bosisio Parini | Recruiting | Bosisio Parini | Lecco | 23842 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23397303 | Background | 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. | |
| 17658255 |
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The results obtained at the end of this clinical trial will be presented at national and international conferences and submitted to peer-reviewed international journals. The raw data of the study will be published among the supplementary materials of scientific articles and/or uploaded to Zenodo, a multidisciplinary repository, managed by CERN in Geneva, which allows researchers to share and preserve research results in any size and form. Depositing data in ZENODO guarantees their compliance with the FAIR principles.
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| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D009135 | Muscular Diseases |
| D009134 | Muscular Atrophy, Spinal |
| D002607 | Charcot-Marie-Tooth Disease |
| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Progression of the neuromuscular disease using the Hammersmith Functional Motor Scale- Expanded (HFMS-E); the minimum value is 0, the maximum value is 69. Higher values mean better outcome. |
| Baseline |
| Variation in gait variability during the 6-Minutes Walking Test | Variation of step duration during the 6MWT extracted from a wearable inertial sensor. Measured in coefficient of variation (%). Higher values mean worse outcome. | Baseline |
User friendliness of the device during activity monitoring in daily life using the Questionnaire on User Friendliness of Activity Monitors (QUFAM). Maximum value is 5, minimum value is 0. Higher values mean higher acceptability. |
| Baseline |
| Physical activity in daily life | Steps/day measured using a wearable inertial sensor. Higher values mean better outcome. | Baseline |
| Scientific Institute IRCCS E. Medea - Polo di Conegliano | Not yet recruiting | Conegliano | Treviso | 31015 | Italy |
|
| Background |
| 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. |
| 16106528 | Background | 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. |
| 2803071 | Background | 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. |
| 12091180 | Background | 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. |
| 27174486 | Background | 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. |
| 36201476 | Background | 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. |
| 34857567 | Background | 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. |
| 29715279 | Background | 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. |
| 32095748 | Background | 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. |
| 19257798 | Background | 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. |
| 38202272 | Background | 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. |
| 32122377 | Background | 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. |
| 31213569 | Background | 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. |
| 31547181 | Background | 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. |
| 21205966 | Background | 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. |
| 41678415 | Derived | Storm FA, Diella E, Molteni LE, Delle Fave M, Meola G, Biffi E, D'Angelo MG. Minute-by minute gait variations during the 6-Minute walk test in subjects with myotonic dystrophy type 1. J Neuromuscul Dis. 2026 Feb 12:22143602251400499. doi: 10.1177/22143602251400499. Online ahead of print. |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D000013 | Congenital Abnormalities |