Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients

NCT ID: NCT03024190

Last Updated: 2018-09-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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

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Stroke Upper Extremity Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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with Kinesiotaping

* stretching exercises combined with Kinesiotaping
* regular OT rehabilitation program for 3 weeks

Group Type EXPERIMENTAL

Kinesiotaping

Intervention Type OTHER

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 exercise

Intervention Type OTHER

15- min stretching exercise for upper extremity twice daily

OT rehabilitation program

Intervention Type OTHER

regular rehabilitation program for 3 weeks

control group

* the patients will receive 15-min stretching exercises
* regular OT rehabilitation program for 3 weeks

Group Type OTHER

stretching exercise

Intervention Type OTHER

15- min stretching exercise for upper extremity twice daily

OT rehabilitation program

Intervention Type OTHER

regular rehabilitation program for 3 weeks

Interventions

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Kinesiotaping

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.

Intervention Type OTHER

stretching exercise

15- min stretching exercise for upper extremity twice daily

Intervention Type OTHER

OT rehabilitation program

regular rehabilitation program for 3 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* stroke with hemiplegia (duration is 3\~6 months after stroke).
* The upper extremity function of participated patients could perform hand grasp and release movements.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

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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Yu Chi Huang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

References

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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.

Reference Type BACKGROUND
PMID: 22984012 (View on PubMed)

Sommerfeld 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.

Reference Type BACKGROUND
PMID: 14684785 (View on PubMed)

Ferro 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.

Reference Type BACKGROUND
PMID: 2892615 (View on PubMed)

Thibaut 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.

Reference Type BACKGROUND
PMID: 23885710 (View on PubMed)

Watanabe 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.

Reference Type BACKGROUND
PMID: 15448577 (View on PubMed)

Bovend'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.

Reference Type BACKGROUND
PMID: 18534551 (View on PubMed)

Harvey 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.

Reference Type BACKGROUND
PMID: 11992980 (View on PubMed)

Neuhaus 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.

Reference Type BACKGROUND
PMID: 7223829 (View on PubMed)

Basaran 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.

Reference Type BACKGROUND
PMID: 22750962 (View on PubMed)

Mesci 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.

Reference Type BACKGROUND
PMID: 19874084 (View on PubMed)

Walker 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.

Reference Type BACKGROUND
PMID: 7063882 (View on PubMed)

Ring 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.

Reference Type BACKGROUND
PMID: 17691399 (View on PubMed)

Lin 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.

Reference Type BACKGROUND
PMID: 21533330 (View on PubMed)

Sahin 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.

Reference Type BACKGROUND
PMID: 21999668 (View on PubMed)

Yan 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.

Reference Type BACKGROUND
PMID: 19363561 (View on PubMed)

Goldstein EM. Spasticity management: an overview. J Child Neurol. 2001 Jan;16(1):16-23. doi: 10.1177/088307380101600104.

Reference Type BACKGROUND
PMID: 11225951 (View on PubMed)

Wagstaff AJ, Bryson HM. Tizanidine. A review of its pharmacology, clinical efficacy and tolerability in the management of spasticity associated with cerebral and spinal disorders. Drugs. 1997 Mar;53(3):435-52. doi: 10.2165/00003495-199753030-00007.

Reference Type BACKGROUND
PMID: 9074844 (View on PubMed)

Olvey EL, Armstrong EP, Grizzle AJ. Contemporary pharmacologic treatments for spasticity of the upper limb after stroke: a systematic review. Clin Ther. 2010 Dec;32(14):2282-303. doi: 10.1016/j.clinthera.2011.01.005.

Reference Type BACKGROUND
PMID: 21353101 (View on PubMed)

Bakheit AM, Thilmann AF, Ward AB, Poewe W, Wissel J, Muller J, Benecke R, Collin C, Muller F, Ward CD, Neumann C. A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke. 2000 Oct;31(10):2402-6. doi: 10.1161/01.str.31.10.2402.

Reference Type BACKGROUND
PMID: 11022071 (View on PubMed)

McCrory P, Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Sandanam J, Davies L, Munns M, Hughes A. Botulinum toxin A for treatment of upper limb spasticity following stroke: a multi-centre randomized placebo-controlled study of the effects on quality of life and other person-centred outcomes. J Rehabil Med. 2009 Jun;41(7):536-44. doi: 10.2340/16501977-0366.

Reference Type BACKGROUND
PMID: 19543664 (View on PubMed)

Ashby J. Choice of route of exposure in mammalian genotoxicity experiments. Environ Mol Mutagen. 1987;10(4):439-40. doi: 10.1002/em.2850100414. No abstract available.

Reference Type BACKGROUND
PMID: 3678211 (View on PubMed)

Lin YC. Botulinum toxin injection for post-stroke spasticity. Muscle Nerve. 2014 Jun;49(6):932. doi: 10.1002/mus.24216. Epub 2014 Apr 8. No abstract available.

Reference Type BACKGROUND
PMID: 24639239 (View on PubMed)

Phadke CP, Ismail F, Boulias C, Gage W, Mochizuki G. The impact of post-stroke spasticity and botulinum toxin on standing balance: a systematic review. Expert Rev Neurother. 2014 Mar;14(3):319-27. doi: 10.1586/14737175.2014.887443. Epub 2014 Feb 10.

Reference Type BACKGROUND
PMID: 24506569 (View on PubMed)

Rojhani-Shirazi Z, Amirian S, Meftahi N. Effects of Ankle Kinesio Taping on Postural Control in Stroke Patients. J Stroke Cerebrovasc Dis. 2015 Nov;24(11):2565-71. doi: 10.1016/j.jstrokecerebrovasdis.2015.07.008. Epub 2015 Aug 29.

Reference Type BACKGROUND
PMID: 26321149 (View on PubMed)

Boeskov B, Carver LT, von Essen-Leise A, Henriksen M. Kinesthetic taping improves walking function in patients with stroke: a pilot cohort study. Top Stroke Rehabil. 2014 Nov-Dec;21(6):495-501. doi: 10.1310/tsr2106-495.

Reference Type BACKGROUND
PMID: 25467397 (View on PubMed)

Janda R, Cencora A, Uzieblo W. [Lysis of thrombi and emboli by means of streptokinase. I. Activation of fibrinolysis, mechanism of plasmin activity, indications and contra-indications, treatment principles]. Przegl Lek. 1969;25(10):701-5. No abstract available. Polish.

Reference Type BACKGROUND
PMID: 4242965 (View on PubMed)

Jaraczewska E, Long C. Kinesio taping in stroke: improving functional use of the upper extremity in hemiplegia. Top Stroke Rehabil. 2006 Summer;13(3):31-42. doi: 10.1310/33KA-XYE3-QWJB-WGT6.

Reference Type BACKGROUND
PMID: 16987790 (View on PubMed)

Hamesh Dash DM. Florence Nightingale's writings. Nurs J India. 1972 May;63(5):149 passim. No abstract available.

Reference Type BACKGROUND
PMID: 4483417 (View on PubMed)

Pandyan AD, Johnson GR, Price CI, Curless RH, Barnes MP, Rodgers H. A review of the properties and limitations of the Ashworth and modified Ashworth Scales as measures of spasticity. Clin Rehabil. 1999 Oct;13(5):373-83. doi: 10.1191/026921599677595404.

Reference Type BACKGROUND
PMID: 10498344 (View on PubMed)

Haugh AB, Pandyan AD, Johnson GR. A systematic review of the Tardieu Scale for the measurement of spasticity. Disabil Rehabil. 2006 Aug 15;28(15):899-907. doi: 10.1080/09638280500404305.

Reference Type BACKGROUND
PMID: 16861197 (View on PubMed)

Li F, Wu Y, Li X. Test-retest reliability and inter-rater reliability of the Modified Tardieu Scale and the Modified Ashworth Scale in hemiplegic patients with stroke. Eur J Phys Rehabil Med. 2014 Feb;50(1):9-15. Epub 2013 Dec 5.

Reference Type BACKGROUND
PMID: 24309501 (View on PubMed)

van Rijthoven AW, Dijkmans BA, Goei The HS, Hermans J, Montnor-Beckers ZL, Jacobs PC, Cats A. Cyclosporin treatment for rheumatoid arthritis: a placebo controlled, double blind, multicentre study. Ann Rheum Dis. 1986 Sep;45(9):726-31. doi: 10.1136/ard.45.9.726.

Reference Type BACKGROUND
PMID: 3532966 (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)

Kesikburun S, Yasar E, Adiguzel E, Guzelkucuk U, Alaca R, Tan AK. Assessment of Spasticity With Sonoelastography Following Stroke: A Feasibility Study. PM R. 2015 Dec;7(12):1254-1260. doi: 10.1016/j.pmrj.2015.05.019. Epub 2015 May 30.

Reference Type BACKGROUND
PMID: 26032348 (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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CMRPG8F1101

Identifier Type: -

Identifier Source: org_study_id

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