OncologyFAAP-ONCT04862130
Validation of the GMFM-88 Scale and of the FAAP-O Scale in Pediatric Patients Affected by Cancer
An observational study of Oncology, run by Associazione Italiana Ematologia Oncologia Pediatrica at 10 sites in Italy.
Trial summary
The primary objective of this study is to validate the Gross Motor Function Measure Scale-88 (GMFM-88) on the Italian pediatric cancer population. The secondary objective is to implement the use of the GMFM-88 in clinical practice by validating a reduced panel of items that will be called the Functional Ability… Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Oncology
- How many people
- 217 participants
- Where
- 10 sitesItaly
- Study dates
- 14 Nov 2019to 22 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents affected by cancer referred to the rehabilitation services of the participants centres.
Who may be able to join
- age between 6 months - 17 years and 11 months
- diagnosis of oncological disease
- being during antineoplastic treatment or up to 1 year off-therapy
- Written informed consent from patient or parents/legal representative, and age-appropriate assent.
Who cannot join
- Patients that are not able and willing to comply with study visits and procedures.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Ospedale Papa Giovanni XXIII, UOS Onco-ematologia Pediatrica
Bergamo, 24127
Ospedale Azienda Sanitaria dell'Alto Adige - Comprensorio di Bolzano Servizio di Riabilitazione Fisica
Bolzano, 39100
IRCCS E. Medea La Nostra Famiglia
Bosisio Parini, Lecco, 23842
IRCCS E. Medea La Nostra Famiglia
Brindisi, 72100
IRCCS E. Medea La Nostra Famiglia
Conegliano, Treviso, 31015
AOU Meyer - UP Riabilitazione
Florence, 50139
IRCCS Istituto Giannina Gaslini - U.O. Med Fisica e riabilitazione
Genova, 16147
Fondazione IRCCS Istituto Nazionale dei Tumori - S.C. Cure palliative, Terapia del Dolore e Riabilitazione
Milan, 20133
A.O.U. Città della Salute e della Scienza - OIRM
Torino, 10126
IRCCS Materno Infantile Burlo Garofolo - S.C. Oncoematologia
Trieste, 34137
About this study
Official title: Rehabilitative Evaluation of Functional Abilities in Children/Adolescents Affected by Cancer: a Validation Study of the GMFM-88 Scale and of the Functional Abilities Assessment in Pediatric Oncology (FAAP-O) Scale
The primary objective of this study is to validate the Gross Motor Function Measure Scale-88 (GMFM-88) on the Italian pediatric cancer population. The secondary objective is to implement the use of the GMFM-88 in clinical practice by validating a reduced panel of items that will be called the Functional Ability Assessment in Pediatric Oncology (FAAP-O) Scale.
Read the detailed description
In recent decades, improvements in the treatment of pediatric cancer patients have resulted in increased survival rates. Consequentially, clinicians now pay more attention to the quality of life of these patients, both during and after treatment. Functional abilities have an important role in the quality of life and these skills can be compromised by the tumor itself or by anti-neoplastic treatments. A recent Cochrane review regarding rehabilitation and motor activity in this population has documented the effectiveness of exercise in children with cancer. Furthermore, to improve the rehabilitation care of pediatric cancer patients it is important to broaden the research by structuring multi-center trials, which allow the collection of longitudinal data. Objective, repeatable, specific, and sensitive rehabilitation assessment tools are needed, to define the functional status of the patient and to measure the motor outcomes. The psychometric properties of a measurement are closely linked to the specific population in which the measurement is used. Currently, there are two validated assessment tools for children/adolescents with cancer used to evaluate functional abilities: The Gross Motor Function Scale-Acute Lymphoblastic Leukemia (GMFM-ALL) and the Motor Performance in Pediatric Oncology (MOON). The ladder has the merit of being structured to evaluate the motor skills of children/adolescents affected by various forms of cancer but it also presents some limits. This test does not investigate functional abilities in a rehabilitation optic and it requires the use of specific materials that can reduce its usability in multicenter trials. The GMFM-ALL scale is a modified version of the Gross Motor Function Measure 88 (GMFM-88) Scale. This scale is specific only for children/adolescents with Lymphoblastic Leukemia and it mainly evaluates motor skills that require a high functional level (i.e. jumps, running), possessed neither by younger children nor by those who show major physical impairments or during specific phases of cancer treatment, such as palliative care.
The GMFM-88 scale is a rehabilitation assessment tool that was originally created to investigate functional abilities in children affected by cerebral palsy (CP) and has subsequently been validated for other populations of pediatric patients. It was also used to evaluate functional abilities in some studies conducted on pediatric cancer patients. Some aspects make this tool easily applicable in multicenter studies: it does not require any material to be administered nor a specific certified training to use it and, lastly, it comprises all principal motor skills including the basic ones (i.e. lying and rolling on the ground).
- Conditions
- Oncology
- Keywords
- Physiotherapy, Rehabilitation, Functional abilities evaluation, motor function evaluation
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer.
Cronbach's alpha. A satisfactory index of a scale's homogeneity should have an alpha coefficient between 0.70 and 0.95.
Measured: up to 1 year
Secondary outcomes (4)
Content validity of the GMFM-88 items in evaluating functional abilities of children and adolescents affected by cancer
Content Validity Ratio (CVR). CVR values range from -1 to +1. A satisfactory CVR should be ≥ 0.70.
Measured: up to 1 year
Construct validity of the FAAP-O in assessing functional abilities of children and adolescents affected by cancer
Cronbach's alpha A satisfactory index of a scale's homogeneity should have an alpha coefficient between 0.70 and 0.95.
Measured: up to 18 months
Inter-observer reliability and intra-observer reliability of the FAAP-O
Interclass Correlation (ICC) ICC values range from 0 to 1. The repeatability of a test is considered high when ICC value is ≥ 0.8.
Measured: through study competition, an average of 2 years
Test-retest reliability of the FAAP-O
Interclass Correlation (ICC) ICC values range from 0 to 1. The repeatability of a test is considered high when ICC value is ≥ 0.8
Measured: through study competition, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start14 Nov 2019
- Primary completion30 Oct 2020
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associazione Italiana Ematologia Oncologia Pediatrica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Rossi, dr, Principal investigator, A.O.U. Città della Salute e della Scienza - OIRM, Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862130
- Sponsor's protocol ID
- FAAP-O
- Acronym
- FAAP-O
- Status last verified
- Jan 2024
- First submitted
- 23 Apr 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, Trama A, Visser O, Brenner H, Ardanaz E, Bielska-Lasota M, Engholm G, Nennecke A, Siesling S, Berrino F, Capocaccia R; EUROCARE-5 Working Group. Cancer survival in Europe 1999-2007 by country and age: results of EUROCARE--5-a population-based study. Lancet Oncol. 2014 Jan;15(1):23-34. doi: 10.1016/S1470-2045(13)70546-1. Epub 2013 Dec 5.
PubMed 24314615Braam KI, van der Torre P, Takken T, Veening MA, van Dulmen-den Broeder E, Kaspers GJ. Physical exercise training interventions for children and young adults during and after treatment for childhood cancer. Cochrane Database Syst Rev. 2016 Mar 31;3(3):CD008796. doi: 10.1002/14651858.CD008796.pub3.
PubMed 27030386Byer L, Kline C, Mueller S. Clinical trials in pediatric neuro-oncology: what is missing and how we can improve. CNS Oncol. 2016 Oct;5(4):233-9. doi: 10.2217/cns-2016-0016. Epub 2016 Sep 12.
PubMed 27616346Corr AM, Liu W, Bishop M, Pappo A, Srivastava DK, Neel M, Rao B, Wilson T, Ness KK. Feasibility and functional outcomes of children and adolescents undergoing preoperative chemotherapy prior to a limb-sparing procedure or amputation. Rehabil Oncol. 2017 Jan;35(1):38-45.
PubMed 28948112Gatta G, Botta L, Rossi S, Aareleid T, Bielska-Lasota M, Clavel J, Dimitrova N, Jakab Z, Kaatsch P, Lacour B, Mallone S, Marcos-Gragera R, Minicozzi P, Sanchez-Perez MJ, Sant M, Santaquilani M, Stiller C, Tavilla A, Trama A, Visser O, Peris-Bonet R; EUROCARE Working Group. Childhood cancer survival in Europe 1999-2007: results of EUROCARE-5--a population-based study. Lancet Oncol. 2014 Jan;15(1):35-47. doi: 10.1016/S1470-2045(13)70548-5. Epub 2013 Dec 5.
PubMed 24314616Gemus M, Palisano R, Russell D, Rosenbaum P, Walter SD, Galuppi B, Lane M. Using the gross motor function measure to evaluate motor development in children with Down syndrome. Phys Occup Ther Pediatr. 2001;21(2-3):69-79.
PubMed 12029855Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16.
PubMed 21370414Gotte M, Kesting S, Albrecht C, Worth A, Bos K, Boos J. MOON-test - determination of motor performance in the pediatric oncology. Klin Padiatr. 2013 May;225(3):133-7. doi: 10.1055/s-0033-1343411. Epub 2013 Apr 18.
PubMed 23599231Lucia A, Ramirez M, San Juan AF, Fleck SJ, Garcia-Castro J, Madero L. Intrahospital supervised exercise training: a complementary tool in the therapeutic armamentarium against childhood leukemia. Leukemia. 2005 Aug;19(8):1334-7. doi: 10.1038/sj.leu.2403799. No abstract available.
PubMed 15931268Ruck-Gibis J, Plotkin H, Hanley J, Wood-Dauphinee S. Reliability of the gross motor function measure for children with osteogenesis imperfecta. Pediatr Phys Ther. 2001 Spring;13(1):10-7.
PubMed 17053645Wright MJ, Halton JM, Martin RF, Barr RD. Long-term gross motor performance following treatment for acute lymphoblastic leukemia. Med Pediatr Oncol. 1998 Aug;31(2):86-90. doi: 10.1002/(sici)1096-911x(199808)31:23.0.co;2-v.
PubMed 9680932Rossi F, Valle M, Carlucci G, Tofani M, Galeoto G, Berchialla P, Sciannameo V, Clari M, Cardano M, Nota F, Bertin D, Calcagno A, Casalaz R, Cerboneschi M, Cervo M, Cornelli A, Fave MD, Esposito M, Ferrarese M, Imazio P, Lorenzon M, Longo L, Naretto G, Orsini N, Panzeri D, Pellegrini C, Peranzoni M, Picone F, Rabusin M, Trabacca A, Zigrino C, Martinuzzi A, Fagioli F, Ricci F. Development of Functional Abilities Assessment in Paediatric Oncology (FAAP-O) Scale for Children and Adolescents Affected by Cancer. Children (Basel). 2025 Sep 1;12(9):1163. doi: 10.3390/children12091163.
PubMed 41007028
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitative Evaluation of Functional Abilities in Children/Adolescents Affected by Cancer: a Validation Study of the GMFM-88 Scale and of the Functional Abilities Assessment in Pediatric Oncology (FAAP-O) Scale
- ClinicalTrials.gov ID
- NCT04862130
- Acronym / sponsor ID
- FAAP-O / FAAP-O
- Conditions
- Oncology
- Keywords
- Physiotherapy, Rehabilitation, Functional abilities evaluation, motor function evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Associazione Italiana Ematologia Oncologia PediatricaUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 27 Apr 2021 (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.
The primary objective of this study is to validate the Gross Motor Function Measure Scale-88 (GMFM-88) on the Italian pediatric cancer population. The secondary objective is to implement the use of the GMFM-88 in clinical practice by validating a reduced panel of items that will be called the Functional Ability Assessment in Pediatric Oncology (FAAP-O) Scale.
Detailed description
In recent decades, improvements in the treatment of pediatric cancer patients have resulted in increased survival rates. Consequentially, clinicians now pay more attention to the quality of life of these patients, both during and after treatment. Functional abilities have an important role in the quality of life and these skills can be compromised by the tumor itself or by anti-neoplastic treatments. A recent Cochrane review regarding rehabilitation and motor activity in this population has documented the effectiveness of exercise in children with cancer. Furthermore, to improve the rehabilitation care of pediatric cancer patients it is important to broaden the research by structuring multi-center trials, which allow the collection of longitudinal data. Objective, repeatable, specific, and sensitive rehabilitation assessment tools are needed, to define the functional status of the patient and to measure the motor outcomes. The psychometric properties of a measurement are closely linked to the specific population in which the measurement is used. Currently, there are two validated assessment tools for children/adolescents with cancer used to evaluate functional abilities: The Gross Motor Function Scale-Acute Lymphoblastic Leukemia (GMFM-ALL) and the Motor Performance in Pediatric Oncology (MOON). The ladder has the merit of being structured to evaluate the motor skills of children/adolescents affected by various forms of cancer but it also presents some limits. This test does not investigate functional abilities in a rehabilitation optic and it requires the use of specific materials that can reduce its usability in multicenter trials. The GMFM-ALL scale is a modified version of the Gross Motor Function Measure 88 (GMFM-88) Scale. This scale is specific only for children/adolescents with Lymphoblastic Leukemia and it mainly evaluates motor skills that require a high functional level (i.e. jumps, running), possessed neither by younger children nor by those who show major physical impairments or during specific phases of cancer treatment, such as palliative care.
The GMFM-88 scale is a rehabilitation assessment tool that was originally created to investigate functional abilities in children affected by cerebral palsy (CP) and has subsequently been validated for other populations of pediatric patients. It was also used to evaluate functional abilities in some studies conducted on pediatric cancer patients. Some aspects make this tool easily applicable in multicenter studies: it does not require any material to be administered nor a specific certified training to use it and, lastly, it comprises all principal motor skills including the basic ones (i.e. lying and rolling on the ground).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents affected by cancer referred to the rehabilitation services of the participants centres.
Key inclusion criteria (4 listed)
- age between 6 months - 17 years and 11 months
- diagnosis of oncological disease
- being during antineoplastic treatment or up to 1 year off-therapy
- Written informed consent from patient or parents/legal representative, and age-appropriate assent.
Key exclusion criteria (1 listed)
- Patients that are not able and willing to comply with study visits and procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer.
Time frame: up to 1 year
Cronbach's alpha. A satisfactory index of a scale's homogeneity should have an alpha coefficient between 0.70 and 0.95.
4 secondary outcomes
Content validity of the GMFM-88 items in evaluating functional abilities of children and adolescents affected by cancer
Time frame: up to 1 year
Construct validity of the FAAP-O in assessing functional abilities of children and adolescents affected by cancer
Time frame: up to 18 months
Inter-observer reliability and intra-observer reliability of the FAAP-O
Time frame: through study competition, an average of 2 years
Test-retest reliability of the FAAP-O
Time frame: through study competition, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 24314615De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, Trama A, Visser O, Brenner H, Ardanaz E, Bielska-Lasota M, Engholm G, Nennecke A, Siesling S, Berrino F, Capocaccia R; EUROCARE-5 Working Group. Cancer survival in Europe 1999-2007 by country and age: results of EUROCARE--5-a population-based study. Lancet Oncol. 2014 Jan;15(1):23-34. doi: 10.1016/S1470-2045(13)70546-1. Epub 2013 Dec 5.
- Background: PubMed 27030386Braam KI, van der Torre P, Takken T, Veening MA, van Dulmen-den Broeder E, Kaspers GJ. Physical exercise training interventions for children and young adults during and after treatment for childhood cancer. Cochrane Database Syst Rev. 2016 Mar 31;3(3):CD008796. doi: 10.1002/14651858.CD008796.pub3.
- Background: PubMed 27616346Byer L, Kline C, Mueller S. Clinical trials in pediatric neuro-oncology: what is missing and how we can improve. CNS Oncol. 2016 Oct;5(4):233-9. doi: 10.2217/cns-2016-0016. Epub 2016 Sep 12.
- Background: PubMed 28948112Corr AM, Liu W, Bishop M, Pappo A, Srivastava DK, Neel M, Rao B, Wilson T, Ness KK. Feasibility and functional outcomes of children and adolescents undergoing preoperative chemotherapy prior to a limb-sparing procedure or amputation. Rehabil Oncol. 2017 Jan;35(1):38-45.
- Background: PubMed 24314616Gatta G, Botta L, Rossi S, Aareleid T, Bielska-Lasota M, Clavel J, Dimitrova N, Jakab Z, Kaatsch P, Lacour B, Mallone S, Marcos-Gragera R, Minicozzi P, Sanchez-Perez MJ, Sant M, Santaquilani M, Stiller C, Tavilla A, Trama A, Visser O, Peris-Bonet R; EUROCARE Working Group. Childhood cancer survival in Europe 1999-2007: results of EUROCARE-5--a population-based study. Lancet Oncol. 2014 Jan;15(1):35-47. doi: 10.1016/S1470-2045(13)70548-5. Epub 2013 Dec 5.
- Background: PubMed 12029855Gemus M, Palisano R, Russell D, Rosenbaum P, Walter SD, Galuppi B, Lane M. Using the gross motor function measure to evaluate motor development in children with Down syndrome. Phys Occup Ther Pediatr. 2001;21(2-3):69-79.
- Background: PubMed 21370414Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16.
- Background: PubMed 23599231Gotte M, Kesting S, Albrecht C, Worth A, Bos K, Boos J. MOON-test - determination of motor performance in the pediatric oncology. Klin Padiatr. 2013 May;225(3):133-7. doi: 10.1055/s-0033-1343411. Epub 2013 Apr 18.
- Background: PubMed 15931268Lucia A, Ramirez M, San Juan AF, Fleck SJ, Garcia-Castro J, Madero L. Intrahospital supervised exercise training: a complementary tool in the therapeutic armamentarium against childhood leukemia. Leukemia. 2005 Aug;19(8):1334-7. doi: 10.1038/sj.leu.2403799. No abstract available.
- Background: PubMed 17053645Ruck-Gibis J, Plotkin H, Hanley J, Wood-Dauphinee S. Reliability of the gross motor function measure for children with osteogenesis imperfecta. Pediatr Phys Ther. 2001 Spring;13(1):10-7.
- Background: PubMed 9680932Wright MJ, Halton JM, Martin RF, Barr RD. Long-term gross motor performance following treatment for acute lymphoblastic leukemia. Med Pediatr Oncol. 1998 Aug;31(2):86-90. doi: 10.1002/(sici)1096-911x(199808)31:23.0.co;2-v.
- Derived from this study: PubMed 41007028Rossi F, Valle M, Carlucci G, Tofani M, Galeoto G, Berchialla P, Sciannameo V, Clari M, Cardano M, Nota F, Bertin D, Calcagno A, Casalaz R, Cerboneschi M, Cervo M, Cornelli A, Fave MD, Esposito M, Ferrarese M, Imazio P, Lorenzon M, Longo L, Naretto G, Orsini N, Panzeri D, Pellegrini C, Peranzoni M, Picone F, Rabusin M, Trabacca A, Zigrino C, Martinuzzi A, Fagioli F, Ricci F. Development of Functional Abilities Assessment in Paediatric Oncology (FAAP-O) Scale for Children and Adolescents Affected by Cancer. Children (Basel). 2025 Sep 1;12(9):1163. doi: 10.3390/children12091163.
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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. This study is not recruiting at the moment.
Francesca Rossi, dr principal investigator
A.O.U. Città della Salute e della Scienza - OIRM, Turin, Italy
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Associazione Italiana Ematologia Oncologia Pediatrica at 10 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer. (time frame: up to 1 year). 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 NCT04862130, which also lists 12 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 31 Jan 2024.