StrokeNCT03024190
Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients
A study testing Kinesiotaping, stretching exercise and OT rehabilitation program in people with Stroke and Upper Extremity Spasticity, run by Chang Gung Memorial Hospital.
Trial summary
Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a brain injury leading to limbs weakness and impaired coordination between agonist and antagonist contraction. PSS leads some physical impairments and functional deficits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Upper Extremity Spasticity
- What is being tested?
- Kinesiotaping, stretching exercise and OT rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke with hemiplegia (duration is 3~6 months after stroke).
- The upper extremity function of participated patients could perform hand grasp and release movements.
Who cannot join
- age is younger than 18 years or older than 80 years
- previous history of upper extremity tendon or neuromuscular injury
- any other systemic neuromuscular disease
- cognition or language impairment leading to communication difficulty
About this study
Official title: The Clinical Effect and Sonographic Findings of Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients
Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a brain injury leading to limbs weakness and impaired coordination between agonist and antagonist contraction. PSS leads some physical impairments and functional deficits. The clinical managements for PSS are stretching and range of motion (ROM) exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications, local injection with phenol or botulism, or surgery. Recently, some investigators tried to use Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in walking ability and upper extremity function facilitation after stroke.
40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40 patients will be randomly divided into the experimental and control groups. In experimental group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. In the control group (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week post intervention, all patients will receive associated physical examinations, hand function evaluations, and sonography.
Read the detailed description
In this study, 40 subacute stroke patients (duration is 3~6 months after stroke) with hemiplegia would be enrolled. Each stroke patient is diagnosed by a neurologist according to the history, physical examination, and brain imaging evaluation. These 40 patients would be randomly divided into a experimental or a control group. All patients in the control and experimental groups will both receive regular rehabilitation therapy including occupational therapy (OT) 3 times per week and one hour for one session OT intervention. Additionally, 15- min stretching exercise for upper extremity twice daily will be performed for 3 weeks in this study. KT intervention in the experimental group: The technique of KT for spastic wrist and fingers in stroke patient will be performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm. The KT will be applied for 5 days one week for 3 weeks.
In this study, all patients in the control and experimental groups will receive the following evaluations before intervention, immediately post intervention, and 2-week after intervention: Physical examinations (modified shworth scale and Tardieu scale), Hand function evaluation (Fugl-Meyer Assessment for upper extremity, box and block test, and Minnesota Manual Dexterity Test), and Musculoskeletal sonography (sonoelastography and shear wave velocity). SPSS software will be used to record and analysis the collecting data. Investigators will analyze and compare the findings of physical examinations, upper extremity function assessments, and musculoskeletal sonography within and between the experimental and control groups before and after interventions.
- Conditions
- Stroke, Upper Extremity Spasticity
- Being tested
- Kinesiotaping, stretching exercise, OT rehabilitation program
- Keywords
- stroke, spasticity, Kinesiotaping, sonography, exercise
- Medical subject headings
- Stroke, Muscle Spasticity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
The technique of Kinesiotaping for spastic wrists and fingers in stroke patients is performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm.
stretching exerciseOther
15- min stretching exercise for upper extremity twice daily
OT rehabilitation programOther
regular rehabilitation program for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| with Kinesiotaping | Experimental | * stretching exercises combined with Kinesiotaping
* regular OT rehabilitation program for 3 weeks Receives: Other: Kinesiotaping; Other: stretching exercise; Other: OT rehabilitation program |
| control group | Other | * the patients will receive 15-min stretching exercises
* regular OT rehabilitation program for 3 weeks Receives: Other: stretching exercise; Other: OT rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function
A physical therapist will use Fugl-Meyer assessment for upper extremity (FMA-UE) to evaluate patient's hand function and analyze the changes on the score of it from baseline till third week and fifth week.
Measured: baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.
Modified Ashworth scale for level of spasticity of affected arm
A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.
Measured: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
Secondary outcomes (3)
the change from baseline on hemiplegic upper extremity sonography
for the flexor carpal ulnaris (FCU), flexor carpal radialis (FCR), and flexor digitorum superficialis (FDS) muscles.
The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degree and the forearm full supination. The measured levels for evaluating FCR, FCU, and FDS muscles will be recorded at first time and use the same level after intervention for each patient. The SWV will be done in the transverse plane and be performed at the maximal cross-section area of the muscles and repeatedly measured for 7 times for each muscle. The sonoelastography will be applied in the longitudinal plane of the detected muscles at the same level of the SWV.
Measured: baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.
Brunnstrom motor recovery stage for motor ability
A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till third week and fifth week.
Measured: baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.
Modified Tardieu scale for level of spasticity of affected arm
A physical therapist will measure the level of spasticity in affected arm by using modified Tardieu scale.
Measured: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Chi Huang, Bachelor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024190
- Sponsor's protocol ID
- CMRPG8F1101
- Status last verified
- Dec 2016
- First submitted
- 27 Dec 2016
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Publications
Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.
PubMed 22984012Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
PubMed 14684785Ferro JA, Macari M, Eizirik DL. Cold-acclimation improves cold-tolerance of diabetic rats. Comp Biochem Physiol A Comp Physiol. 1987;88(3):425-9. doi: 10.1016/0300-9629(87)90057-0.
PubMed 2892615Thibaut A, Chatelle C, Ziegler E, Bruno MA, Laureys S, Gosseries O. Spasticity after stroke: physiology, assessment and treatment. Brain Inj. 2013;27(10):1093-105. doi: 10.3109/02699052.2013.804202. Epub 2013 Jul 25.
PubMed 23885710Watanabe T. The role of therapy in spasticity management. Am J Phys Med Rehabil. 2004 Oct;83(10 Suppl):S45-9. doi: 10.1097/01.phm.0000141130.58285.da.
PubMed 15448577Bovend'Eerdt TJ, Newman M, Barker K, Dawes H, Minelli C, Wade DT. The effects of stretching in spasticity: a systematic review. Arch Phys Med Rehabil. 2008 Jul;89(7):1395-406. doi: 10.1016/j.apmr.2008.02.015. Epub 2008 Jun 13.
PubMed 18534551Harvey L, Herbert R, Crosbie J. Does stretching induce lasting increases in joint ROM? A systematic review. Physiother Res Int. 2002;7(1):1-13. doi: 10.1002/pri.236.
PubMed 11992980Neuhaus BE, Ascher ER, Coullon BA, Donohue MV, Einbond A, Glover JM, Goldberg SR, Takai VL. A survey of rationales for and against hand splinting in hemiplegia. Am J Occup Ther. 1981 Feb;35(2):83-90. doi: 10.5014/ajot.35.2.83.
PubMed 7223829Basaran A, Emre U, Karadavut KI, Balbaloglu O, Bulmus N. Hand splinting for poststroke spasticity: a randomized controlled trial. Top Stroke Rehabil. 2012 Jul-Aug;19(4):329-37. doi: 10.1310/tsr1904-329.
PubMed 22750962Mesci N, Ozdemir F, Kabayel DD, Tokuc B. The effects of neuromuscular electrical stimulation on clinical improvement in hemiplegic lower extremity rehabilitation in chronic stroke: a single-blind, randomised, controlled trial. Disabil Rehabil. 2009;31(24):2047-54. doi: 10.3109/09638280902893626.
PubMed 19874084Walker JB. Modulation of spasticity: prolonged suppression of a spinal reflex by electrical stimulation. Science. 1982 Apr 9;216(4542):203-4. doi: 10.1126/science.7063882.
PubMed 7063882Ring H, Weingarden H. Neuromodulation by functional electrical stimulation (FES) of limb paralysis after stroke. Acta Neurochir Suppl. 2007;97(Pt 1):375-80. doi: 10.1007/978-3-211-33079-1_49.
PubMed 17691399Lin Z, Yan T. Long-term effectiveness of neuromuscular electrical stimulation for promoting motor recovery of the upper extremity after stroke. J Rehabil Med. 2011 May;43(6):506-10. doi: 10.2340/16501977-0807.
PubMed 21533330Sahin N, Ugurlu H, Albayrak I. The efficacy of electrical stimulation in reducing the post-stroke spasticity: a randomized controlled study. Disabil Rehabil. 2012;34(2):151-6. doi: 10.3109/09638288.2011.593679. Epub 2011 Oct 15.
PubMed 21999668Yan T, Hui-Chan CW. Transcutaneous electrical stimulation on acupuncture points improves muscle function in subjects after acute stroke: a randomized controlled trial. J Rehabil Med. 2009 Apr;41(5):312-6. doi: 10.2340/16501977-0325.
PubMed 19363561
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect and Sonographic Findings of Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT03024190
- Acronym / sponsor ID
- CMRPG8F1101
- Conditions
- Stroke, Upper Extremity Spasticity
- Keywords
- stroke, spasticity, Kinesiotaping, sonography, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 18 Jan 2017 (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.
Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a brain injury leading to limbs weakness and impaired coordination between agonist and antagonist contraction. PSS leads some physical impairments and functional deficits. The clinical managements for PSS are stretching and range of motion (ROM) exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications, local injection with phenol or botulism, or surgery. Recently, some investigators tried to use Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in walking ability and upper extremity function facilitation after stroke.
40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40 patients will be randomly divided into the experimental and control groups. In experimental group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. In the control group (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week post intervention, all patients will receive associated physical examinations, hand function evaluations, and sonography.
Detailed description
In this study, 40 subacute stroke patients (duration is 3~6 months after stroke) with hemiplegia would be enrolled. Each stroke patient is diagnosed by a neurologist according to the history, physical examination, and brain imaging evaluation. These 40 patients would be randomly divided into a experimental or a control group. All patients in the control and experimental groups will both receive regular rehabilitation therapy including occupational therapy (OT) 3 times per week and one hour for one session OT intervention. Additionally, 15- min stretching exercise for upper extremity twice daily will be performed for 3 weeks in this study. KT intervention in the experimental group: The technique of KT for spastic wrist and fingers in stroke patient will be performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm. The KT will be applied for 5 days one week for 3 weeks.
In this study, all patients in the control and experimental groups will receive the following evaluations before intervention, immediately post intervention, and 2-week after intervention: Physical examinations (modified shworth scale and Tardieu scale), Hand function evaluation (Fugl-Meyer Assessment for upper extremity, box and block test, and Minnesota Manual Dexterity Test), and Musculoskeletal sonography (sonoelastography and shear wave velocity). SPSS software will be used to record and analysis the collecting data. Investigators will analyze and compare the findings of physical examinations, upper extremity function assessments, and musculoskeletal sonography within and between the experimental and control groups before and after interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with Kinesiotaping | Experimental | Other: Kinesiotaping, Other: stretching exercise, Other: OT rehabilitation program* stretching exercises combined with Kinesiotaping * regular OT rehabilitation program for 3 weeks |
| control group | Other | Other: stretching exercise, Other: OT rehabilitation program* the patients will receive 15-min stretching exercises * regular OT rehabilitation program for 3 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stroke with hemiplegia (duration is 3~6 months after stroke).
- The upper extremity function of participated patients could perform hand grasp and release movements.
Key exclusion criteria (4 listed)
- age is younger than 18 years or older than 80 years
- previous history of upper extremity tendon or neuromuscular injury
- any other systemic neuromuscular disease
- cognition or language impairment leading to communication difficulty
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 |
|---|---|---|
| KinesiotapingThe technique of Kinesiotaping for spastic wrists and fingers in stroke patients is performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm. | Other | with Kinesiotaping |
| stretching exercise15- min stretching exercise for upper extremity twice daily | Other | control group, with Kinesiotaping |
| OT rehabilitation programregular rehabilitation program for 3 weeks | Other | control group, with Kinesiotaping |
Primary outcome
Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function
Time frame: baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.
A physical therapist will use Fugl-Meyer assessment for upper extremity (FMA-UE) to evaluate patient's hand function and analyze the changes on the score of it from baseline till third week and fifth week.
Modified Ashworth scale for level of spasticity of affected arm
Time frame: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.
3 secondary outcomes
the change from baseline on hemiplegic upper extremity sonography
Time frame: baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.
Brunnstrom motor recovery stage for motor ability
Time frame: baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.
Modified Tardieu scale for level of spasticity of affected arm
Time frame: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
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 24 Sep 2018.
- Background: PubMed 22984012Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.
- Background: PubMed 14684785Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
- Background: PubMed 2892615Ferro JA, Macari M, Eizirik DL. Cold-acclimation improves cold-tolerance of diabetic rats. Comp Biochem Physiol A Comp Physiol. 1987;88(3):425-9. doi: 10.1016/0300-9629(87)90057-0.
- Background: PubMed 23885710Thibaut A, Chatelle C, Ziegler E, Bruno MA, Laureys S, Gosseries O. Spasticity after stroke: physiology, assessment and treatment. Brain Inj. 2013;27(10):1093-105. doi: 10.3109/02699052.2013.804202. Epub 2013 Jul 25.
- Background: PubMed 15448577Watanabe T. The role of therapy in spasticity management. Am J Phys Med Rehabil. 2004 Oct;83(10 Suppl):S45-9. doi: 10.1097/01.phm.0000141130.58285.da.
- Background: PubMed 18534551Bovend'Eerdt TJ, Newman M, Barker K, Dawes H, Minelli C, Wade DT. The effects of stretching in spasticity: a systematic review. Arch Phys Med Rehabil. 2008 Jul;89(7):1395-406. doi: 10.1016/j.apmr.2008.02.015. Epub 2008 Jun 13.
- Background: PubMed 11992980Harvey L, Herbert R, Crosbie J. Does stretching induce lasting increases in joint ROM? A systematic review. Physiother Res Int. 2002;7(1):1-13. doi: 10.1002/pri.236.
- Background: PubMed 7223829Neuhaus BE, Ascher ER, Coullon BA, Donohue MV, Einbond A, Glover JM, Goldberg SR, Takai VL. A survey of rationales for and against hand splinting in hemiplegia. Am J Occup Ther. 1981 Feb;35(2):83-90. doi: 10.5014/ajot.35.2.83.
- Background: PubMed 22750962Basaran A, Emre U, Karadavut KI, Balbaloglu O, Bulmus N. Hand splinting for poststroke spasticity: a randomized controlled trial. Top Stroke Rehabil. 2012 Jul-Aug;19(4):329-37. doi: 10.1310/tsr1904-329.
- Background: PubMed 19874084Mesci N, Ozdemir F, Kabayel DD, Tokuc B. The effects of neuromuscular electrical stimulation on clinical improvement in hemiplegic lower extremity rehabilitation in chronic stroke: a single-blind, randomised, controlled trial. Disabil Rehabil. 2009;31(24):2047-54. doi: 10.3109/09638280902893626.
- Background: PubMed 7063882Walker JB. Modulation of spasticity: prolonged suppression of a spinal reflex by electrical stimulation. Science. 1982 Apr 9;216(4542):203-4. doi: 10.1126/science.7063882.
- Background: PubMed 17691399Ring H, Weingarden H. Neuromodulation by functional electrical stimulation (FES) of limb paralysis after stroke. Acta Neurochir Suppl. 2007;97(Pt 1):375-80. doi: 10.1007/978-3-211-33079-1_49.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Yu Chi Huang, Bachelor principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping, stretching exercise and OT rehabilitation program in people with Stroke and Upper Extremity Spasticity, run by Chang Gung Memorial Hospital.
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 4 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function (time frame: baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.). 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 NCT03024190, which also lists 35 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 24 Sep 2018.