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Status unknownNCT02557711Updated Mar 30, 2016

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

An observational study in Cerebrovascular Accident, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2016-03-30.

Sponsored by Chang Gung Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
50
Sex
All
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Study 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 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.

02

Conditions studied

  • Cerebrovascular Accident

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Keywords

  • spasticity
  • stroke
  • ultrasound elastography
  • acoustic radiation force impulse
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 50 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

refer from physiatrists in Kaohsiung Chang Gung Memorial Hospital

Inclusion criteria

  • stroke patients with hemiplegia and biceps brachii muscle spasticity.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Deviceultrasound elastography, acoustic radiation force impulse

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

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What researchers measure

Primary outcomes

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

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

Secondary outcomes

  1. the thickness of biceps brachii

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

  2. Heckmatt scale

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

  3. strain ratio

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

  4. Dynamic Sonoelastography Score(DS score)

    Time frame: 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

    Time frame: 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

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

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Study locations

1 site
  • Chang Gung Memorial Hospital
    Kaohsiung, Taiwan
08

References and documents

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 ↗
  • Wu CH, Chang KV, Mio S, Chen WS, Wang TG. Sonoelastography of the plantar fascia. Radiology. 2011 May;259(2):502-7. doi: 10.1148/radiol.11101665. Epub 2011 Feb 25. PubMed 21357519 ↗
  • Sconfienza LM, Silvestri E, Orlandi D, Fabbro E, Ferrero G, Martini C, Sardanelli F, Cimmino MA. Real-time sonoelastography of the plantar fascia: comparison between patients with plantar fasciitis and healthy control subjects. Radiology. 2013 Apr;267(1):195-200. doi: 10.1148/radiol.12120969. Epub 2013 Jan 7. PubMed 23297327 ↗
  • Niitsu M, Michizaki A, Endo A, Takei H, Yanagisawa O. Muscle hardness measurement by using ultrasound elastography: a feasibility study. Acta Radiol. 2011 Feb 1;52(1):99-105. doi: 10.1258/ar.2010.100190. PubMed 21498334 ↗
  • Yanagisawa O, Niitsu M, Kurihara T, Fukubayashi T. Evaluation of human muscle hardness after dynamic exercise with ultrasound real-time tissue elastography: a feasibility study. Clin Radiol. 2011 Sep;66(9):815-9. doi: 10.1016/j.crad.2011.03.012. Epub 2011 May 6. PubMed 21529793 ↗
  • Botar-Jid C, Damian L, Dudea SM, Vasilescu D, Rednic S, Badea R. The contribution of ultrasonography and sonoelastography in assessment of myositis. Med Ultrason. 2010 Jun;12(2):120-6. PubMed 21173939 ↗
  • Vasilescu D, Vasilescu D, Dudea S, Botar-Jid C, Sfrangeu S, Cosma D. Sonoelastography contribution in cerebral palsy spasticity treatment assessment, preliminary report: a systematic review of the literature apropos of seven patients. Med Ultrason. 2010 Dec;12(4):306-10. PubMed 21210016 ↗
  • Bhatia KS, Rasalkar DD, Lee YP, Wong KT, King AD, Yuen HY, Ahuja AT. Evaluation of real-time qualitative sonoelastography of focal lesions in the parotid and submandibular glands: applications and limitations. Eur Radiol. 2010 Aug;20(8):1958-64. doi: 10.1007/s00330-010-1756-0. Epub 2010 Apr 21. PubMed 20407904 ↗
  • Nightingale K, Soo MS, Nightingale R, Trahey G. Acoustic radiation force impulse imaging: in vivo demonstration of clinical feasibility. Ultrasound Med Biol. 2002 Feb;28(2):227-35. doi: 10.1016/s0301-5629(01)00499-9. PubMed 11937286 ↗
  • Fuchs D, Hausen A, Hoefler E, Schonitzer D, Werner ER, Dierich MP, Hengster P, Reibnegger G, Schulz T, Wachter H. Activated T cells in addition to LAV/HTLV-III infection: a necessary precondition for development of AIDS. Cancer Detect Prev Suppl. 1987;1:583-7. PubMed 3500785 ↗
  • Goycoolea HG, Goycoolea MV, Farfan CR. Racial and familial factors in otitis media. A point prevalence study on Easter Island. Arch Otolaryngol Head Neck Surg. 1988 Feb;114(2):147-9. doi: 10.1001/archotol.1988.01860140045018. PubMed 3337770 ↗
  • Bai M, Du L, Gu J, Li F, Jia X. Virtual touch tissue quantification using acoustic radiation force impulse technology: initial clinical experience with solid breast masses. J Ultrasound Med. 2012 Feb;31(2):289-94. doi: 10.7863/jum.2012.31.2.289. PubMed 22298873 ↗
  • Friedrich-Rust M, Romenski O, Meyer G, Dauth N, Holzer K, Grunwald F, Kriener S, Herrmann E, Zeuzem S, Bojunga J. Acoustic Radiation Force Impulse-Imaging for the evaluation of the thyroid gland: a limited patient feasibility study. Ultrasonics. 2012 Jan;52(1):69-74. doi: 10.1016/j.ultras.2011.06.012. Epub 2011 Jul 7. PubMed 21788057 ↗
  • Kang J, Kwon H, Cho J, Oh J, Nam K, Yoon S, Kang M, Lee S, Han S. Comparative study of shear wave velocities using acoustic radiation force impulse technology in hepatocellular carcinoma: the extent of radiofrequency ablation. Gut Liver. 2012 Jul;6(3):362-7. doi: 10.5009/gnl.2012.6.3.362. Epub 2012 May 2. PubMed 22844566 ↗
  • Park GY, Kwon DR. Sonoelastographic evaluation of medial gastrocnemius muscles intrinsic stiffness after rehabilitation therapy with botulinum toxin a injection in spastic cerebral palsy. Arch Phys Med Rehabil. 2012 Nov;93(11):2085-9. doi: 10.1016/j.apmr.2012.06.024. Epub 2012 Jul 7. PubMed 22776155 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02557711
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Sep 23, 2015
Start date
Jun 2016
Primary completion
May 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Mar 30, 2016

Study contacts

Pong Ya-Ping, MD
Contact
yaping0707@gmail.com
889-7-7317123 ext. 6286
Pong Ya-Ping, MD
study chair · Rehabilitation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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