Muscular DystrophiesNCT06666816
Observational Study to Observe Variations of Gait Parameters in Patients With Neuromuscular Diseases
An observational study of Muscular Dystrophies and Myopathies, run by IRCCS Eugenio Medea at 2 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Dystrophies, Myopathies, Spinal Muscular Atrophy (SMA)
- What is being tested?
- inapplicable
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- 27 Oct 2017to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potentially eligible participants will be selected from clinical databases of IRCCS Medea
Who may be able to join
- Ambulant adult patients with genetic diagnosis of muscular dystrophy/myopathy (dystrophinopathies, muscular dystrophies and congenital and non-congenital myopathies), of spinal muscular atrophy (SMA) and with molecular diagnosis of Charcot-Marie Tooth 1 or 2.
- independent walking, even with assistance;
Who cannot join
- Dilated or ischemic heart disease with moderate impairment;
- Chronic respiratory failure: forced vital capacity (FVC) < 40%; more than 5% of nocturnal time spent with peripheral oxygen saturation levels < 90.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Scientific Institute IRCCS E. Medea - Sede di Bosisio Parini
Bosisio Parini, Lecco, 23842
Fabio A Storm, PhD, +39031877111, fabio.storm@lanostrafamiglia.it
Emilia Biffi, Phd, emilia.biffi@lanostrafamiglia.it
- Not yet recruiting
Scientific Institute IRCCS E. Medea - Polo di Conegliano
Conegliano, Treviso, 31015
Eleonora Martini, MD, eleonora.martini@lanostrafamiglia.it
About this study
Official title: Observational Study for the Identification of Fatigue and Gait Biomarkers in Populations With Neuromuscular Pathologies in the Clinical Context and Daily Life
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.
- Conditions
- Muscular Dystrophies, Myopathies, Spinal Muscular Atrophy (SMA), Charcot Marie Tooth Disease
- Being tested
- inapplicable
- Medical subject headings
- Muscular Dystrophies, Muscular Diseases, Muscular Atrophy, Spinal, Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inapplicableOther
inapplicable
| Study group | Role | What they receive |
|---|---|---|
| Group with neuromuscular disease | Not described Receives: Other: inapplicable | |
| Control Group | Not described Receives: Other: inapplicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Baseline
Clinical progression of the neuromuscular disease
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start27 Oct 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Muscular DystrophiesStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666816
- Sponsor's protocol ID
- GIP1112
- Other IDs
- RC 2024-2026 to E. Biffi
- Status last verified
- Jan 2026
- First submitted
- 25 Oct 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23397303O'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.
PubMed 17658255Berard 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.
PubMed 16106528Krupp 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.
PubMed 2803071ATS 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.
PubMed 12091180Erratum: 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.
PubMed 27174486Mikolaizak 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.
PubMed 36201476Mazza 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.
PubMed 34857567Storm 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.
PubMed 29715279Goldhahn 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.
PubMed 32095748Stull 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.
PubMed 19257798Leale 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.
PubMed 38202272Kennedy 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.
PubMed 32122377Retory 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.
PubMed 31213569Ghislieri 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.
PubMed 31547181
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Identification of Fatigue and Gait Biomarkers in Populations With Neuromuscular Pathologies in the Clinical Context and Daily Life
- ClinicalTrials.gov ID
- NCT06666816
- Acronym / sponsor ID
- GIP1112
- Conditions
- Muscular Dystrophies, Myopathies, Spinal Muscular Atrophy (SMA), Charcot Marie Tooth Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with neuromuscular disease | – | Other: inapplicable |
| Control Group | – | Other: inapplicable |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potentially eligible participants will be selected from clinical databases of IRCCS Medea
Key inclusion criteria (2 listed)
- Ambulant adult patients with genetic diagnosis of muscular dystrophy/myopathy (dystrophinopathies, muscular dystrophies and congenital and non-congenital myopathies), of spinal muscular atrophy (SMA) and with molecular diagnosis of Charcot-Marie Tooth 1 or 2.
- independent walking, even with assistance;
Key exclusion criteria (2 listed)
- Dilated or ischemic heart disease with moderate impairment;
- Chronic respiratory failure: forced vital capacity (FVC) < 40%; more than 5% of nocturnal time spent with peripheral oxygen saturation levels < 90.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inapplicableinapplicable | Other | Control Group, Group with neuromuscular disease |
Primary outcome
Variation in walking speed during a 6-minutes walking test
Time frame: Baseline
Variation in walking speed calculated as difference between the first and the final minute of the a 6-minutes walking test
Subjective fatigue
Time frame: Baseline
Evaluation of subjective fatigue using the Fatigue Severity Scale (FSS). The minimum value is 0, the maximum is 63. Higher scores mean worse outcome.
3 secondary outcomes
Clinical progression of the neuromuscular disease
Time frame: Baseline
Clinical progression of the neuromuscular disease
Time frame: Baseline
Variation in gait variability during the 6-Minutes Walking Test
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 23397303Rabinovich 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.
- Background: PubMed 17658255O'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.
- Background: PubMed 16106528Berard 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.
- Background: PubMed 2803071Krupp 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.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 27174486Erratum: 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.
- Background: PubMed 36201476Mikolaizak 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.
- Background: PubMed 34857567Mazza 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.
- Background: PubMed 29715279Storm 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.
- Background: PubMed 32095748Goldhahn 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.
- Background: PubMed 19257798Stull 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.
- Background: PubMed 38202272Leale 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Dystrophies and Myopathies, run by IRCCS Eugenio Medea at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio A Storm, PhD (+39031877111, fabio.storm@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in walking speed during a 6-minutes walking test (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06666816, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.