Brain ConcussionNCT02945605
Effects of Early Vestibular Rehabilitation in Patients With Dizziness and Balance Disorders After Sport Concussion
A study testing Early Vestibular Rehabilitation in people with Brain Concussion, run by University of Michigan at 1 site in United States.
Trial summary
This study examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Early Vestibular Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 21 Mar 2017
- 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Dizziness or balance problems within 10 days of concussion
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Effects of Early Vestibular Rehabilitation Compared to Standard Care in Patients With Dizziness and Balance Disorders After Sport and Recreation Concussion
This study examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. Half of the participants will receive early vestibular rehabilitation added to standard of care, while the other half will receive standard of care only.
Read the detailed description
As awareness of concussion and the numbers of reported concussions increase every year in the last few years, so does the need for more effective treatment strategies. Concussions can lead to a variety of symptoms that may last from days to weeks after injury.[1] Dizziness and vestibular impairments are prevalent in up to 81% of patients after concussion.[2,3] Additionally, dizziness and vestibular impairments are predictive of prolonged recovery times after concussion.[4] Although there are few studies suggesting that vestibular rehabilitation after concussion is promising,[5,6] there continues to be a void in well-controlled studies verifying that vestibular rehabilitation can be used to treat patients with dizziness and balance disorders after concussion. Due to the lack of controlled studies and current practice patterns, patients with concussions are not seen for physical therapy until weeks or months after their injury. The purpose of this study is to examine the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems), and improving the timeline to achieve medical clearance to return to activities such as sports and work activities, when compared to STANDARD care. The findings of this study are expected to provide medical and sports related professionals with appropriate concussion treatment strategies and improve outcomes of patients suffering from concussion.
- Conditions
- Brain Concussion
- Being tested
- Early Vestibular Rehabilitation, Standard of Care
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Vestibular RehabilitationOther
Two visits/week for a maximum of 5 weeks will be provided with the approximate duration for each visit estimated at 50-60 minutes. Consistent with a previously validated framework for exercise prescription in patients with concussion, the exercises provided by the treating therapist can be classified into five main exercise categories:
- Eye-Head coordination, gaze stability and convergence exercises
- Sitting balance
- Standing static balance (i.e. feet-in-place)
- Dynamic balance (feet moving, but not walking)
- Ambulation (gait exercises)
- Other exercises: Sport specific exercises, Canalith repositioning maneuvers are recorded as others
Standard of CareOther
Standard care as directed by a physician.
| Study group | Role | What they receive |
|---|---|---|
| Early Vestibular Rehabilitation | Experimental | Participants in this group will receive a customized vestibular rehabilitation program designed and implemented by a vestibular physical therapist. The vestibular physical therapy must be initiated within 72 hours after randomization. Participants in this group will continue to receive standard of care treatment as directed by their physician. Receives: Other: Early Vestibular Rehabilitation; Other: Standard of Care |
| Standard of Care | Active comparator | Participants in this group will receive standard care as directed by their physician. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory
The change is calculated by subtracting the score obtained at a designated time point from the initial score.
Measured: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
Secondary outcomes (9)
Change in Dizziness Handicap Inventory (DHI)
The DHI assesses the individual's handicap due to their dizziness problem in 25 items relating to physical, emotional, and functional domains. The highest overall score of the test is 100 with higher scores indicating greater dizziness handicap. Participants who are 18 years or older on the initial assessment day will complete the original DHI, and participants younger than 18 will complete the adolescents version of DHI.
The change is calculated by subtracting the score obtained at a designated time point from the initial score.
Measured: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
Global Rating of Change (GRC)
GRC scales ask that a person assess his or her current health status, recall that status at a previous time-point, and then calculate the difference between the two. The scoring ranges from "A very great deal worse (-7)" to "A very great deal better (7)."
Measured: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
Change in Vestibular Ocular Motor Screening (VOMS)
Participants will complete the VOMS testing seven items: smooth pursuit, saccades (horizontal and vertical), vestibulo-ocular reflex (VOR) (horizontal and vertical), vision motion sensitivity testing, and Near-Point-of-Convergence (NPC) distance (three trials). Participants are asked to report the intensity, using a scale from 0 (none) -10 (severe), of four possible symptoms (headache, dizziness, nausea, and fogginess). The participant reports at baseline and after each of the seven VOMS tests. Any change in each of the four symptoms from baseline is reported for each of the seven VOMS items. The total symptom score is calculated by summating any change in four symptoms from baseline for each of the seven VOMS tests.
The change is calculated by subtracting the score obtained at the termination of the study from the initial score.
Measured: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Functional Gait Assessment (FGA)
The FGA assesses the ability to walk with head turns, changes of speed, pivot turns, backwards and narrow base of support. The scale for each item ranges from 0-3, where 0 means severe impairment and 3 means normal. The highest possible score is 30. Higher scores indicate better performance.
The change is calculated by subtracting the score obtained at the termination of the study from the initial score.
Measured: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Original and Cognitive Timed Up & Go (TUG)
The TUG is a timed test during which the participant stands from a chair, walks three meters at their normal walking speed, returns to the chair, and sits down. The cognitive TUG is completed while counting backwards in threes from a random start point. An automaticity index is calculated to assess the impact of both dual tasks. The speed under the dual-task condition is expressed as a percentage of the speed under the single-task condition: (single task/dual task) *100. A maximal achievable score of 100% indicated no decrease in performance under the dual-task condition. This index is developed as a method for standardizing the assessment of dual-task performance and its effect on automaticity.
The change is calculated by subtracting the score obtained at the termination of the study from the initial score.
Measured: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Clinical Dynamic Visual Acuity
First perform the test for static visual acuity: patient may wear glasses or contacts. Have patient sit/stand about 10 feet away from eye chart (LogMAR). Have them read the lowest line they can see until they cannot correctly identify all the letters in a given line. Note which line this is. Dynamic Visual Acuity: Stand behind patient and tilt their head down 20°. Rotate their head at 2 Hz (240 beats/min on metronome) and have them read the lowest line possible until they cannot correctly identify all the letters in a given line. Note which line this is. Abnormal Test: greater than 2 line difference or if patient experiences dizziness which they rate on a 0 to 10 scale.
The change is calculated by subtracting the score obtained at the termination of the study from the initial score.
Measured: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Original and dual task Balance Error Scoring System (BESS)
Participants will perform the BESS while on a NeuroCom® portable force plate system. Participants are asked to stand on the force plate and maintain balance with eyes closed and hands on their iliac crests under 6 different conditions (20 seconds each):
- firm surface, feet together
- firm surface, single leg stance
- firm surface, tandem stance
- foam surface, feet together
- foam surface, single leg stance
- foam surface, tandem stance
This procedure allows for simultaneous computation of sway by the force plate and clinical assessment of balance errors as indicated by the BESS.
For the dual task Balance Error Scoring System, the BESS will be completed as per BESS protocol with a cognitive task of serial threes. For the serial threes task, participants are given a random number between 80 and 100 and instructed to subtract by threes. When participants fail to perform a correct subtraction, it is considered an error.
Measured: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Limits of Stability (LOS) Test
The LOS quantifies the maximum distance the patient can intentionally displace their Center of Gravity (COG) in the four cardinal directions and the four diagonal directions, and maintain stability at those positions. Measured parameters are reaction time, COG movement velocity, directional control, end point excursion, and maximum excursion.
The change is calculated by subtracting the score obtained at the termination of the study from the initial score.
Measured: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Time until medical clearance to return to sports/activities
The number of days between concussion and the day when a physician provided full clearance to return to sport/activities
Measured: The number of days between concussion and the day when a physician provided full clearance to return to sport/activities (retrieved from medical record) up to 52 weeks from concussion date. [the date of clearance - the concussion date]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start9 Mar 2017
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Why it stopped: Because of recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bara Alsalaheen, PT, Ph.D., University of Michigan
- Investigators
- Bara Alsalaheen, PT, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945605
- Sponsor's protocol ID
- HUM00109407
- Status last verified
- May 2018
- First submitted
- 24 Oct 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7.
PubMed 24601910Zhou G, Brodsky JR. Objective vestibular testing of children with dizziness and balance complaints following sports-related concussions. Otolaryngol Head Neck Surg. 2015 Jun;152(6):1133-9. doi: 10.1177/0194599815576720. Epub 2015 Mar 27.
PubMed 25820582Corwin DJ, Wiebe DJ, Zonfrillo MR, Grady MF, Robinson RL, Goodman AM, Master CL. Vestibular Deficits following Youth Concussion. J Pediatr. 2015 May;166(5):1221-5. doi: 10.1016/j.jpeds.2015.01.039. Epub 2015 Mar 5.
PubMed 25748568Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.
PubMed 21712482Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
PubMed 20588094Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.
PubMed 24855132
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Vestibular Rehabilitation Compared to Standard Care in Patients With Dizziness and Balance Disorders After Sport and Recreation Concussion
- ClinicalTrials.gov ID
- NCT02945605
- Acronym / sponsor ID
- HUM00109407
- Conditions
- Brain Concussion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of recruitment challenges
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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 examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. Half of the participants will receive early vestibular rehabilitation added to standard of care, while the other half will receive standard of care only.
Detailed description
As awareness of concussion and the numbers of reported concussions increase every year in the last few years, so does the need for more effective treatment strategies. Concussions can lead to a variety of symptoms that may last from days to weeks after injury.[1] Dizziness and vestibular impairments are prevalent in up to 81% of patients after concussion.[2,3] Additionally, dizziness and vestibular impairments are predictive of prolonged recovery times after concussion.[4] Although there are few studies suggesting that vestibular rehabilitation after concussion is promising,[5,6] there continues to be a void in well-controlled studies verifying that vestibular rehabilitation can be used to treat patients with dizziness and balance disorders after concussion. Due to the lack of controlled studies and current practice patterns, patients with concussions are not seen for physical therapy until weeks or months after their injury. The purpose of this study is to examine the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems), and improving the timeline to achieve medical clearance to return to activities such as sports and work activities, when compared to STANDARD care. The findings of this study are expected to provide medical and sports related professionals with appropriate concussion treatment strategies and improve outcomes of patients suffering from concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Vestibular Rehabilitation | Experimental | Other: Early Vestibular Rehabilitation, Other: Standard of CareParticipants in this group will receive a customized vestibular rehabilitation program designed and implemented by a vestibular physical therapist. The vestibular physical therapy must be initiated within 72 hours after randomization. Participants in this group will continue to receive standard of care treatment as directed by their physician. |
| Standard of Care | Active comparator | Other: Standard of CareParticipants in this group will receive standard care as directed by their physician. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Dizziness or balance problems within 10 days of concussion
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Early Vestibular RehabilitationTwo visits/week for a maximum of 5 weeks will be provided with the approximate duration for each visit estimated at 50-60 minutes. Consistent with a previously validated framework for exercise prescription in patients with concussion, the exercises provided by the treating therapist can be classified into five main exercise categories: 1. Eye-Head coordination, gaze stability and convergence exercises 2. Sitting balance 3. Standing static balance (i.e. feet-in-place) 4. Dynamic balance (feet moving, but not walking) 5. Ambulation (gait exercises) 6. Other exercises: Sport specific exercises, Canalith repositioning maneuvers are recorded as others | Other | Early Vestibular Rehabilitation |
| Standard of CareStandard care as directed by a physician. | Other | Early Vestibular Rehabilitation, Standard of Care |
Primary outcome
Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory
Time frame: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
The change is calculated by subtracting the score obtained at a designated time point from the initial score.
9 secondary outcomes
Change in Dizziness Handicap Inventory (DHI)
Time frame: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
Global Rating of Change (GRC)
Time frame: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)
Change in Vestibular Ocular Motor Screening (VOMS)
Time frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Functional Gait Assessment (FGA)
Time frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Original and Cognitive Timed Up & Go (TUG)
Time frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Clinical Dynamic Visual Acuity
Time frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Original and dual task Balance Error Scoring System (BESS)
Time frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Change in Limits of Stability (LOS) Test
Time frame: Up to 5 weeks, or after full resolution of symptoms, whichever occurs first
Time until medical clearance to return to sports/activities
Time frame: The number of days between concussion and the day when a physician provided full clearance to return to sport/activities (retrieved from medical record) up to 52 weeks from concussion date. [the date of clearance - the concussion date]
Results and safety
The study was stopped early (reason given: Because of recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Background: PubMed 24601910Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7.
- Background: PubMed 25820582Zhou G, Brodsky JR. Objective vestibular testing of children with dizziness and balance complaints following sports-related concussions. Otolaryngol Head Neck Surg. 2015 Jun;152(6):1133-9. doi: 10.1177/0194599815576720. Epub 2015 Mar 27.
- Background: PubMed 25748568Corwin DJ, Wiebe DJ, Zonfrillo MR, Grady MF, Robinson RL, Goodman AM, Master CL. Vestibular Deficits following Youth Concussion. J Pediatr. 2015 May;166(5):1221-5. doi: 10.1016/j.jpeds.2015.01.039. Epub 2015 Mar 5.
- Background: PubMed 21712482Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.
- Background: PubMed 20588094Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
- Background: PubMed 24855132Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.
- Individual participant dataSharing planned: No
Related trials for Brain Concussion
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Bara Alsalaheen, PT, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Vestibular Rehabilitation in people with Brain Concussion, run by University of Michigan at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 30 May 2018. 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 United States. 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 was stopped early (reason given: Because of recruitment challenges). Results are not available in the source record.
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?
Change in Sports Concussion Assessment Tool (SCATIII) Symptom Inventory (time frame: At every 7 days since concussion and the end of the study (up to 5 weeks, or after full resolution of symptoms, whichever occurs first)). 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 NCT02945605, which also lists 6 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 30 May 2018.