FatigueNCT05880745
The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality
A study testing Nine-Hole Peg Test (NHPT) in people with Fatigue and Functionality, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to investigate the effect of the level of hand fatigability on general fatigue and functionality by comparing Relapsing-Remitting Multiple Sclerosis individuals with age and sex-matched healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Functionality, Multiple Sclerosis
- What is being tested?
- Nine-Hole Peg Test (NHPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2018to 9 Dec 2019
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient Group Being diagnosed with Relapsing Remitting Multiple Sclerosis. Being between the ages of 18-60. Agree to participate in the study. Not having an attack in the last 1 month. Expanded Disability Status Scale (GEDS) score between 1-5.5. Spasticity level in the wrist and finger flexors is between 0 and 1+ according to the Modified Ashworth Scale.
- Not having any other neurological or orthopedic or rheumatological disease affecting the upper extremity.
- Healthy Adult Group Agree to participate in the study. Being between the ages of 18-60. Not having a neurological disease or an orthopedic or rheumatological disease affecting the upper extremity.
- Having similar demographic characteristics with the patient group participating in the study.
Who cannot join
- Using antidepressants. Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality: A Controlled Study
The objective of this study is to investigate the effect of the level of hand fatigability on general fatigue and functionality by comparing Relapsing-Remitting Multiple Sclerosis individuals with age and sex-matched healthy individuals. 23 RRMS and 23 healthy people (mean age 40.08, 21 females, mean time since diagnosis 9.43 years, mean Expanded Disability Status Scale 3.23) were included in the study. To examine participants' fatigability level; for gross and pinch-grip Dynamic and Static Fatigue Index, for manual dexterity and functionality level Scale for the Assessment and Rating of Ataxia (SARA), Nine Hole Peg Test (NHPT) and Dexterity Questionnaire-24 (DextQ-24) were used. While Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS) were used to examine general fatigue, Beck Depression Inventory (BDI) was used to assess emotional status. The mean age of healthy individuals with RRMS was 40.08 ± 9.81 years, and the EDSS means of individuals with RRMS was 3.23 ± 1.47. 21 of both groups were female and 2 were male. It was determined that the difference between MS individuals and healthy individuals' SARA, NHPT, FSS and FIS averages, initial and final strength values was statistically significant (p≤0.05), and the decrease in force in individuals with RRMS was higher than in healthy individuals. However, there was no difference between RRMS and healthy individuals in terms of fatigability levels examined with the Dynamic and Static Fatigue Index (p>0.05). While the relationship of Static and Dynamic Fatigue Index with FSS and FIS was not statistically significant, the relationship was significant with DextQ-24's dressing, daily activities and TV/CD/DVD subsections (p<0.05). In individuals with early RRMS, there is a decrease in the repetitive (dynamic) and continuous (static) contractions of the rough and pinch grip strength, and this decrease is related to the negative impact on the daily living activities and functionality of the individuals. In particular, motor fatigue should be addressed from the early stages of rehabilitation programs that will be planned to maintain the active participation of individuals with RRMS in their daily living activities. To show motor fatigue with indices, further studies with different fatigue indices and individuals with RRMS at different EDSS levels are needed.
Read the detailed description
Introduction Multiple sclerosis (MS) is the most common neurological disease that causes disability in young adults. It usually progresses with exacerbations and remissions and causes various problems by affecting the central nervous system in different localizations.
Fatigue is one of the most common symptoms of MS and has the greatest impact on the patient's quality of life . Fatigability, which is defined as motor and muscle fatigue during motor tasks, is the exercise-induced decrease in the muscle's ability to produce power or force during sustainable tasks . In individuals with MS, fatigability levels are higher than in healthy individuals, as the nervous system cannot provide the necessary activation stimulus during maximum voluntary or continuous contractions . From the early stages of the disease, individuals with MS face problems such as decreased grip strength, and difficulty in holding small objects, which reduce dexterity and complicate daily living activities .
When fatigue studies in MS are examined; It was observed that the studies focused mostly on the lower extremity and walking, and the studies on the upper extremity were also quite limited . To the best of our knowledge, our study is the first in its field to evaluate rough and pinching hand fatigability, general fatigue, and functionality levels in Relapsing-Remitting MS (RRMS) patients and compare them with age- and sex-matched healthy individuals.
It is stated that the EDSS, which we use to evaluate the disability levels of RRMS patients, is not sensitive enough to evaluate functional parameters such as dexterity and cognition in MS . Therefore, other specific assessment methods such as the Ataxia Rating and Rating Scale (SARA), the Nine-Hole Peg Test (NHPT), and the Skill Questionnaire-24 (DextQ-24) were used to determine the level of functioning. SARA is an internationally accepted scale that is frequently used in the evaluation of ataxia. NHPT is the gold standard of performance-based assessment, which detects the patient's progress over time and is sensitive to changes in treatment . DextQ-24, which was developed to measure manual dexterity and consists of 24 questions, is divided into five subgroups washing/care, dressing, food and kitchen, daily activities, TV/CD/DVD. The lowest total score is 24, and the highest is 96. An increase in the score means a decrease in dexterity. Beck Depression Inventory (BDI) is a valid and reliable depression scale for neurological diseases .
The Fatigue Severity Scale (FSS) was used to determine the severity of the fatigue levels of individuals during the day, and the Fatigue Impact Scale (FIS) was used to determine the effects of fatigue on activities of daily living. The Turkish validity and reliability study of both scales was conducted by Armutlu et al. Static and dynamic fatigue levels in the coarse and pinch grip were assessed with a Jamar® digital hand dynamometer and pinch meter, respectively, in the standard measuring position recommended by the American Association of Hand Therapists . For the Dynamic Fatigue Index, a maximum of 15 voluntary contractions were requested from the participant. No rest was given between contractions and the number of remaining contractions was reported to the participant. The highest value of the first 3 contractions (MVC1) and the highest value of the last 3 contractions (MVC2) were recorded and the dynamic fatigue index was calculated with the formula 100*[1-(MVC2/MVC1)]. For the Static Fatigue Index, after a one-minute rest break, the participant was asked to maintain the maximum voluntary contraction for 30 seconds and the participant was not informed about the remaining time. Assuming that the participant can sustain the maximum voluntary contraction for 30 seconds, taking into account the area generated in the graph (Hypothetical Area Under the Force Curve [HAUC]) and the area calculated by the time the participant can walk (Actual Area Under the Power Curve [AUC]) Static Fatigue Index 100*[1- (AUC/HAUC)] formula.
The multi-dimensional evaluation of MS, which threatens all aspects of life and causes limitations in daily living activities, from the early period has an important place in the treatment and rehabilitation of individuals with MS. Determination of hand fatigability is essential to understand the decrease in performance in daily life in individuals with MS and to understand its reflection on upper extremity functionality and to plan targeted rehabilitation. Our study draws attention to the fact that hand fatigability may increase in activities that require repetitive and continuous contraction in individuals with RRMS from the early period and its relationship with upper extremity functionality. For a clearer distinction of fatigability, studies with different and more objective assessments of fatigue index and more studies with different types and different EDSS levels in individuals with RRMS are needed.
- Conditions
- Fatigue, Functionality, Multiple Sclerosis, Dexterity
- Being tested
- Nine-Hole Peg Test (NHPT)
- Keywords
- multiple sclerosis, fatigue, hand fatigability, manuel dexterity
- Medical subject headings
- Fatigue, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nine-Hole Peg Test (NHPT)Diagnostic test
Also called Ataxia Rating and Rating Scale (SARA), Dexterity Questionnaire-24 (DextQ-24), Beck Depression Inventory (BDI), The Fatigue Severity Scale (FSS)
Ataxia Rating and Rating Scale (SARA) for coordination Nine-Hole Peg Test (NHPT) and Dexterity Questionnaire-24 (DextQ-24) for manuel dexterity Beck Depression Inventory (BDI) for depression level The Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS) for general fatigue level Static and dynamic fatigue levels for hand fatigability
| Study group | Role | What they receive |
|---|---|---|
| patient group | Experimental | Patients with MS Receives: Diagnostic Test: Nine-Hole Peg Test (NHPT) |
| healthy group | Experimental | age-gender matched healthy persons Receives: Diagnostic Test: Nine-Hole Peg Test (NHPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale (EDSS)
determination of everyone's disease severity- high score( high disability)
Measured: 1year
Modified Ashworth Scale (MAS)
spacticity level range 0-5(high score increased spacticity
Measured: 1 year
Secondary outcomes (5)
Ataxia Rating and Rating Scale (SARA)
ataxia level- per item 0-2 - high score high ataxia
Measured: 1 year
Nine-Hole Peg Test (NHPT), and the Dexterity Questionnaire-24 (DextQ-24)
manuel dexterity- min- max score 0-96- high score loss of dexterity
Measured: 1 year
Beck Depression Scale
depression level min-max 0-63- high score high depression level
Measured: 1 year
Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS)
general fatigue- min -max 7-63- high score high fatigue
Measured: 1 year
Dynamic and Static Fatigue Index
hand fatigability assessment- high score high fatigability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start8 Dec 2018
- Primary completion10 Jun 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- age-gender matched patient and healthy groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dudu ŞİMŞEK, Pamukkale University
- Investigators
- DUDU ŞIMŞEK, PhD student, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880745
- Sponsor's protocol ID
- PamukkaleU-sımsek-MS-Tez-002
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simsek D, Cetisli-Korkmaz N, Bir LS. Hand fatigability, self-reported fatigue, and functionality in individuals with multiple sclerosis: A cross-sectional study. Mult Scler Relat Disord. 2024 Nov;91:105863. doi: 10.1016/j.msard.2024.105863. Epub 2024 Sep 1.
PubMed 39245025
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality: A Controlled Study
- ClinicalTrials.gov ID
- NCT05880745
- Acronym / sponsor ID
- PamukkaleU-sımsek-MS-Tez-002
- Conditions
- Fatigue, Functionality, Multiple Sclerosis, Dexterity
- Keywords
- multiple sclerosis, fatigue, hand fatigability, manuel dexterity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 8 Dec 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 30 May 2023 (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 objective of this study is to investigate the effect of the level of hand fatigability on general fatigue and functionality by comparing Relapsing-Remitting Multiple Sclerosis individuals with age and sex-matched healthy individuals. 23 RRMS and 23 healthy people (mean age 40.08, 21 females, mean time since diagnosis 9.43 years, mean Expanded Disability Status Scale 3.23) were included in the study. To examine participants' fatigability level; for gross and pinch-grip Dynamic and Static Fatigue Index, for manual dexterity and functionality level Scale for the Assessment and Rating of Ataxia (SARA), Nine Hole Peg Test (NHPT) and Dexterity Questionnaire-24 (DextQ-24) were used. While Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS) were used to examine general fatigue, Beck Depression Inventory (BDI) was used to assess emotional status. The mean age of healthy individuals with RRMS was 40.08 ± 9.81 years, and the EDSS means of individuals with RRMS was 3.23 ± 1.47. 21 of both groups were female and 2 were male. It was determined that the difference between MS individuals and healthy individuals' SARA, NHPT, FSS and FIS averages, initial and final strength values was statistically significant (p≤0.05), and the decrease in force in individuals with RRMS was higher than in healthy individuals. However, there was no difference between RRMS and healthy individuals in terms of fatigability levels examined with the Dynamic and Static Fatigue Index (p>0.05). While the relationship of Static and Dynamic Fatigue Index with FSS and FIS was not statistically significant, the relationship was significant with DextQ-24's dressing, daily activities and TV/CD/DVD subsections (p<0.05). In individuals with early RRMS, there is a decrease in the repetitive (dynamic) and continuous (static) contractions of the rough and pinch grip strength, and this decrease is related to the negative impact on the daily living activities and functionality of the individuals. In particular, motor fatigue should be addressed from the early stages of rehabilitation programs that will be planned to maintain the active participation of individuals with RRMS in their daily living activities. To show motor fatigue with indices, further studies with different fatigue indices and individuals with RRMS at different EDSS levels are needed.
Detailed description
Introduction Multiple sclerosis (MS) is the most common neurological disease that causes disability in young adults. It usually progresses with exacerbations and remissions and causes various problems by affecting the central nervous system in different localizations.
Fatigue is one of the most common symptoms of MS and has the greatest impact on the patient's quality of life . Fatigability, which is defined as motor and muscle fatigue during motor tasks, is the exercise-induced decrease in the muscle's ability to produce power or force during sustainable tasks . In individuals with MS, fatigability levels are higher than in healthy individuals, as the nervous system cannot provide the necessary activation stimulus during maximum voluntary or continuous contractions . From the early stages of the disease, individuals with MS face problems such as decreased grip strength, and difficulty in holding small objects, which reduce dexterity and complicate daily living activities .
When fatigue studies in MS are examined; It was observed that the studies focused mostly on the lower extremity and walking, and the studies on the upper extremity were also quite limited . To the best of our knowledge, our study is the first in its field to evaluate rough and pinching hand fatigability, general fatigue, and functionality levels in Relapsing-Remitting MS (RRMS) patients and compare them with age- and sex-matched healthy individuals.
It is stated that the EDSS, which we use to evaluate the disability levels of RRMS patients, is not sensitive enough to evaluate functional parameters such as dexterity and cognition in MS . Therefore, other specific assessment methods such as the Ataxia Rating and Rating Scale (SARA), the Nine-Hole Peg Test (NHPT), and the Skill Questionnaire-24 (DextQ-24) were used to determine the level of functioning. SARA is an internationally accepted scale that is frequently used in the evaluation of ataxia. NHPT is the gold standard of performance-based assessment, which detects the patient's progress over time and is sensitive to changes in treatment . DextQ-24, which was developed to measure manual dexterity and consists of 24 questions, is divided into five subgroups washing/care, dressing, food and kitchen, daily activities, TV/CD/DVD. The lowest total score is 24, and the highest is 96. An increase in the score means a decrease in dexterity. Beck Depression Inventory (BDI) is a valid and reliable depression scale for neurological diseases .
The Fatigue Severity Scale (FSS) was used to determine the severity of the fatigue levels of individuals during the day, and the Fatigue Impact Scale (FIS) was used to determine the effects of fatigue on activities of daily living. The Turkish validity and reliability study of both scales was conducted by Armutlu et al. Static and dynamic fatigue levels in the coarse and pinch grip were assessed with a Jamar® digital hand dynamometer and pinch meter, respectively, in the standard measuring position recommended by the American Association of Hand Therapists . For the Dynamic Fatigue Index, a maximum of 15 voluntary contractions were requested from the participant. No rest was given between contractions and the number of remaining contractions was reported to the participant. The highest value of the first 3 contractions (MVC1) and the highest value of the last 3 contractions (MVC2) were recorded and the dynamic fatigue index was calculated with the formula 100*[1-(MVC2/MVC1)]. For the Static Fatigue Index, after a one-minute rest break, the participant was asked to maintain the maximum voluntary contraction for 30 seconds and the participant was not informed about the remaining time. Assuming that the participant can sustain the maximum voluntary contraction for 30 seconds, taking into account the area generated in the graph (Hypothetical Area Under the Force Curve [HAUC]) and the area calculated by the time the participant can walk (Actual Area Under the Power Curve [AUC]) Static Fatigue Index 100*[1- (AUC/HAUC)] formula.
The multi-dimensional evaluation of MS, which threatens all aspects of life and causes limitations in daily living activities, from the early period has an important place in the treatment and rehabilitation of individuals with MS. Determination of hand fatigability is essential to understand the decrease in performance in daily life in individuals with MS and to understand its reflection on upper extremity functionality and to plan targeted rehabilitation. Our study draws attention to the fact that hand fatigability may increase in activities that require repetitive and continuous contraction in individuals with RRMS from the early period and its relationship with upper extremity functionality. For a clearer distinction of fatigability, studies with different and more objective assessments of fatigue index and more studies with different types and different EDSS levels in individuals with RRMS are needed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- age-gender matched patient and healthy groups
| Arm | Type | Receives |
|---|---|---|
| patient group | Experimental | Diagnostic Test: Nine-Hole Peg Test (NHPT)Patients with MS |
| healthy group | Experimental | Diagnostic Test: Nine-Hole Peg Test (NHPT)age-gender matched healthy persons |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient Group Being diagnosed with Relapsing Remitting Multiple Sclerosis. Being between the ages of 18-60. Agree to participate in the study. Not having an attack in the last 1 month. Expanded Disability Status Scale (GEDS) score between 1-5.5. Spasticity level in the wrist and finger flexors is between 0 and 1+ according to the Modified Ashworth Scale.
- Not having any other neurological or orthopedic or rheumatological disease affecting the upper extremity.
- Healthy Adult Group Agree to participate in the study. Being between the ages of 18-60. Not having a neurological disease or an orthopedic or rheumatological disease affecting the upper extremity.
- Having similar demographic characteristics with the patient group participating in the study.
Key exclusion criteria (1 listed)
- Using antidepressants. Refusal to participate in the study
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 |
|---|---|---|
| Nine-Hole Peg Test (NHPT)Also: Ataxia Rating and Rating Scale (SARA), Dexterity Questionnaire-24 (DextQ-24), Beck Depression Inventory (BDI), The Fatigue Severity Scale (FSS)Ataxia Rating and Rating Scale (SARA) for coordination Nine-Hole Peg Test (NHPT) and Dexterity Questionnaire-24 (DextQ-24) for manuel dexterity Beck Depression Inventory (BDI) for depression level The Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS) for general fatigue level Static and dynamic fatigue levels for hand fatigability | Diagnostic test | healthy group, patient group |
Primary outcome
Expanded Disability Status Scale (EDSS)
Time frame: 1year
determination of everyone's disease severity- high score( high disability)
Modified Ashworth Scale (MAS)
Time frame: 1 year
spacticity level range 0-5(high score increased spacticity
5 secondary outcomes
Ataxia Rating and Rating Scale (SARA)
Time frame: 1 year
Nine-Hole Peg Test (NHPT), and the Dexterity Questionnaire-24 (DextQ-24)
Time frame: 1 year
Beck Depression Scale
Time frame: 1 year
Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS)
Time frame: 1 year
Dynamic and Static Fatigue Index
Time frame: 1 year
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 30 May 2023.
- Derived from this study: PubMed 39245025Simsek D, Cetisli-Korkmaz N, Bir LS. Hand fatigability, self-reported fatigue, and functionality in individuals with multiple sclerosis: A cross-sectional study. Mult Scler Relat Disord. 2024 Nov;91:105863. doi: 10.1016/j.msard.2024.105863. Epub 2024 Sep 1.
- Individual participant dataSharing planned: No
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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.
DUDU ŞIMŞEK, PhD student study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nine-Hole Peg Test (NHPT) in people with Fatigue and Functionality, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Expanded Disability Status Scale (EDSS) (time frame: 1year). 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 NCT05880745, which also lists 1 linked publication.
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 30 May 2023.