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

NCT03024190 | Completed

• 1 other identifier: CMRPG8F1101
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Stroke; Upper Extremity Spasticity

Keywords

stroke; spasticity; Kinesiotaping; sonography; exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.

• Brunnstrom motor recovery stage for motor ability

  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

  baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.

Study Arms (2)

with Kinesiotaping

EXPERIMENTAL

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

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

Other: stretching exercise; Other: OT rehabilitation program

Interventions

Kinesiotaping 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.

with Kinesiotaping

stretching exercise OTHER

15- min stretching exercise for upper extremity twice daily

control group; with Kinesiotaping

OT rehabilitation program OTHER

regular rehabilitation program for 3 weeks

control group; with Kinesiotaping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (35)

• 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.

  PMID: 22984012 BACKGROUND

• 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.

  PMID: 14684785 BACKGROUND

• 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.

  PMID: 2892615 BACKGROUND

• 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.

  PMID: 23885710 BACKGROUND

• 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.

  PMID: 15448577 BACKGROUND

• 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.

  PMID: 18534551 BACKGROUND

• 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.

  PMID: 11992980 BACKGROUND

• 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.

  PMID: 7223829 BACKGROUND

• 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.

  PMID: 22750962 BACKGROUND

• 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.

  PMID: 19874084 BACKGROUND

• 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.

  PMID: 7063882 BACKGROUND

• 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.

  PMID: 17691399 BACKGROUND

• 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.

  PMID: 21533330 BACKGROUND

• 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.

  PMID: 21999668 BACKGROUND

• 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.

  PMID: 19363561 BACKGROUND

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

  PMID: 11225951 BACKGROUND

• 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.

  PMID: 9074844 BACKGROUND

• 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.

  PMID: 21353101 BACKGROUND

• 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.

  PMID: 11022071 BACKGROUND

• 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.

  PMID: 19543664 BACKGROUND

• 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.

  PMID: 3678211 BACKGROUND

• 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.

  PMID: 24639239 BACKGROUND

• 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.

  PMID: 24506569 BACKGROUND

• 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.

  PMID: 26321149 BACKGROUND

• 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.

  PMID: 25467397 BACKGROUND

• 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.

  PMID: 4242965 BACKGROUND

• 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.

  PMID: 16987790 BACKGROUND

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

  PMID: 4483417 BACKGROUND

• 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.

  PMID: 10498344 BACKGROUND

• 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.

  PMID: 16861197 BACKGROUND

• 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.

  PMID: 24309501 BACKGROUND

• 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.

  PMID: 3532966 BACKGROUND

• 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.

  PMID: 19117179 BACKGROUND

• 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.

  PMID: 26032348 BACKGROUND

• 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.

  PMID: 22776155 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Motor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yu Chi Huang, Bachelor

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 18, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 24, 2018

Record last verified: 2016-12