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Cerebrovascular AccidentNCT02557711

The Findings of Ultrasound Elastography and ARFI in Strokes Patients With Spastic Elbow Flexor

An observational study of Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/ ARFI imaging in spasticity evaluation of stroke patients. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cerebrovascular Accident
What is being tested?
ultrasound elastography, acoustic radiation force impulse
Type of treatment
Medical device
How many people
50 participants
Where
1 siteTaiwan
Study dates
Jun 2016to Sep 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: refer from physiatrists in Kaohsiung Chang Gung Memorial Hospital

Who may be able to join

  • stroke patients with hemiplegia and biceps brachii muscle spasticity.

Who cannot join

  • elbow joint contracture deformity
  • combined other neuromuscular system disease
  • affected upper extremity has local infection
  • patient who can't follow instruction, who is restlessness and whose elbow can't meet the positioning criteria

Trial locations and contacts

1 site in 1 country.

Pong Ya-Ping, MD contact

889-7-7317123 ext. 6286

yaping0707@gmail.com

Taiwan1 site

  • Chang Gung Memorial Hospital

    Kaohsiung City

Other trials in Taiwan

About this study

Official title: The Correlation Between Clinical Examination and Ultrasound Elastography Acoustic Radiation Force Impulse Findings in Hemiplegic Patients With Elbow Flexor Spasticity After Stroke

The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/ ARFI imaging in spasticity evaluation of stroke patients.

Read the detailed description

Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS) are the most commonly used tools for spasticity assessment. But these clinic methods cannot reveal the architecture and stiffness of muscles. In recent years, ultrasound elastography and acoustic radiation force impulse (ARFI) are used in musculoskeletal disorders, including spasticity. There are no studies about the correlation between spasticity and ultrasound elastography /ARFI imaging in stroke patients. The investigators will enroll 50 stroke patients with hemiplegia and biceps brachii muscle spasticity. One physical therapist will measure MAS and MTS for spasticity of biceps brachii muscle. Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation. The evaluations of B-mode ultrasound, elastography and ARFI included Heckmatt scale, biceps brachii ratio, strain ratio, dynamic sonoelastography score, color intensity, and shear wave velocity. After performing all assessments, the investigators will analyze the correlation between the clinic tools and elastography/ ARFI imaging and evaluate the reliability of elastography/ ARFI imaging in spasticity evaluation.

Being tested
ultrasound elastography, acoustic radiation force impulse
Keywords
spasticity, stroke, ultrasound elastography, acoustic radiation force impulse
Medical subject headings
Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasound elastography, acoustic radiation force impulseDevice

    Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS)

    Measured: patients will be evaluated within 1 month after basic history taking and consent signing

Secondary outcomes (6)

  1. the thickness of biceps brachii

    Measured: patients will be evaluated within 1 month after basic history taking and signing consent

  2. Heckmatt scale

    Measured: patients will be evaluated within 1 month after finishing history taking and consent signing

  3. strain ratio

    Measured: patients will be evaluated within 1 month after finishing history taking and consent signing

  4. Dynamic Sonoelastography Score(DS score)

    Measured: patients will be evaluated within 1 month after finishing history taking and consent signing

  5. The mean values of the intensity of red, green, and blue on histogram of bicep brachii

    Measured: patients will be evaluated within 1 month after finishing history taking and consent signing

  6. shear wave velocity within region of interest between biceps brachii and brachialis

    Measured: patients will be evaluated within 1 month after finishing history taking and consent signing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionMay 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02557711
Sponsor's protocol ID
CMRPG8D0951
Status last verified
Mar 2016
First submitted
17 Sep 2015
Last updated
30 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • van Wijck FM, Pandyan AD, Johnson GR, Barnes MP. Assessing motor deficits in neurological rehabilitation: patterns of instrument usage. Neurorehabil Neural Repair. 2001;15(1):23-30. doi: 10.1177/154596830101500104.

    PubMed 11527276

  • Ansari NN, Naghdi S, Hasson S, Mousakhani A, Nouriyan A, Omidvar Z. Inter-rater reliability of the Modified Modified Ashworth Scale as a clinical tool in measurements of post-stroke elbow flexor spasticity. NeuroRehabilitation. 2009;24(3):225-9. doi: 10.3233/NRE-2009-0472.

    PubMed 19458429

  • Kaya T, Karatepe AG, Gunaydin R, Koc A, Altundal Ercan U. Inter-rater reliability of the Modified Ashworth Scale and modified Modified Ashworth Scale in assessing poststroke elbow flexor spasticity. Int J Rehabil Res. 2011 Mar;34(1):59-64. doi: 10.1097/MRR.0b013e32833d6cdf.

    PubMed 20671560

  • Blackburn M, van Vliet P, Mockett SP. Reliability of measurements obtained with the modified Ashworth scale in the lower extremities of people with stroke. Phys Ther. 2002 Jan;82(1):25-34. doi: 10.1093/ptj/82.1.25.

    PubMed 11784275

  • Ansari NN, Naghdi S, Moammeri H, Jalaie S. Ashworth Scales are unreliable for the assessment of muscle spasticity. Physiother Theory Pract. 2006 Jun;22(3):119-25. doi: 10.1080/09593980600724188.

    PubMed 16848350

  • Ansari NN, Naghdi S, Arab TK, Jalaie S. The interrater and intrarater reliability of the Modified Ashworth Scale in the assessment of muscle spasticity: limb and muscle group effect. NeuroRehabilitation. 2008;23(3):231-7.

    PubMed 18560139

  • Mehrholz J, Wagner K, Meissner D, Grundmann K, Zange C, Koch R, Pohl M. Reliability of the Modified Tardieu Scale and the Modified Ashworth Scale in adult patients with severe brain injury: a comparison study. Clin Rehabil. 2005 Oct;19(7):751-9. doi: 10.1191/0269215505cr889oa.

    PubMed 16250194

  • Alhusaini AA, Dean CM, Crosbie J, Shepherd RB, Lewis J. Evaluation of spasticity in children with cerebral palsy using Ashworth and Tardieu Scales compared with laboratory measures. J Child Neurol. 2010 Oct;25(10):1242-7. doi: 10.1177/0883073810362266. Epub 2010 Mar 10.

    PubMed 20223745

  • Mackey AH, Walt SE, Lobb G, Stott NS. Intraobserver reliability of the modified Tardieu scale in the upper limb of children with hemiplegia. Dev Med Child Neurol. 2004 Apr;46(4):267-72. doi: 10.1017/s0012162204000428.

    PubMed 15077704

  • Pierani A, Heguy A, Fujii H, Roeder RG. Activation of octamer-containing promoters by either octamer-binding transcription factor 1 (OTF-1) or OTF-2 and requirement of an additional B-cell-specific component for optimal transcription of immunoglobulin promoters. Mol Cell Biol. 1990 Dec;10(12):6204-15. doi: 10.1128/mcb.10.12.6204-6215.1990.

    PubMed 2123291

  • Ansari NN, Naghdi S, Hasson S, Azarsa MH, Azarnia S. The Modified Tardieu Scale for the measurement of elbow flexor spasticity in adult patients with hemiplegia. Brain Inj. 2008 Dec;22(13-14):1007-12. doi: 10.1080/02699050802530557.

    PubMed 19117179

  • Pillen S, van Keimpema M, Nievelstein RA, Verrips A, van Kruijsbergen-Raijmann W, Zwarts MJ. Skeletal muscle ultrasonography: Visual versus quantitative evaluation. Ultrasound Med Biol. 2006 Sep;32(9):1315-21. doi: 10.1016/j.ultrasmedbio.2006.05.028.

    PubMed 16965971

  • Picelli A, Bonetti P, Fontana C, Barausse M, Dambruoso F, Gajofatto F, Girardi P, Manca M, Gimigliano R, Smania N. Is spastic muscle echo intensity related to the response to botulinum toxin type A in patients with stroke? A cohort study. Arch Phys Med Rehabil. 2012 Jul;93(7):1253-8. doi: 10.1016/j.apmr.2012.02.005. Epub 2012 Apr 12.

    PubMed 22502807

  • Tudisco C, Bisicchia S, Stefanini M, Antonicoli M, Masala S, Simonetti G. Tendon quality in small unilateral supraspinatus tendon tears. Real-time sonoelastography correlates with clinical findings. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):393-8. doi: 10.1007/s00167-013-2551-7. Epub 2013 Jun 16.

    PubMed 23771348

  • Buck AR, Verstraete N, Li Y, Schweizer A, Snedeker JG, Buck FM. Detection of small tendon lesions by sonoelastographic visualization of strain profile differences: initial experiences. Skeletal Radiol. 2012 Sep;41(9):1073-9. doi: 10.1007/s00256-011-1349-2. Epub 2012 Jan 5.

    PubMed 22218832

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 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: status not confirmed, as of the sponsor's last update on 30 Mar 2016. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pong Ya-Ping, MD (889-7-7317123 ext. 6286, yaping0707@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS) (time frame: patients will be evaluated within 1 month after basic history taking and consent signing). 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 NCT02557711, which also lists 29 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 Mar 2016.

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