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

NCT ID: NCT02557711

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebrovascular Accident

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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ultrasound elastography, acoustic radiation force impulse

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* stroke patients with hemiplegia and biceps brachii muscle spasticity.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pong Ya-Ping, MD

Role: STUDY_CHAIR

Rehabilitation

Locations

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Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Pong Ya-Ping, MD

Role: CONTACT

889-7-7317123 ext. 6286

References

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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.

Reference Type BACKGROUND
PMID: 11527276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19458429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20671560 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11784275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16848350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18560139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16250194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20223745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15077704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2123291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19117179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16965971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22502807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23771348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22218832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21357519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23297327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21498334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21529793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21173939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21210016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20407904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11937286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3500785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3337770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22298873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21788057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22844566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22776155 (View on PubMed)

Other Identifiers

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CMRPG8D0951

Identifier Type: -

Identifier Source: org_study_id

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