The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial

Trials

Anand D Pandyan⁴  Steve G Sturman²  Sissi Ispoglou⁵  Julie Simpson³  Cameron Lindsay¹ 

[1] Physiotherapy Department, Sandwell and West Birmingham NHS Trust and School of Health and Rehabilitation, Keele University, Mackay Building, Keele, Staffordshire ST5 5BG, UK;Department of Neurology, Sandwell and West Birmingham NHS Trust, City Hospital Birmingham, Dudley Road, Birmingham, West Midlands B18 7QH, UK;Pharmacy Department, Sandwell and West Birmingham NHS Trust, City Hospital Birmingham, Dudley Road, Birmingham, West Midlands B18 7QH, UK;School of Health and Rehabilitation, Keele University, Mackay Building, Keele, Staffordshire ST5 5BG, UK;Department of Elderly Care, Sandwell and West Birmingham NHS Trust, City Hospital Birmingham, Dudley Road, Birmingham, West Midlands B18 7QH, UK

关键词: Protocol;    Randomised controlled trial;    Contractures;    OnabotulinumtoxinA;    Stroke;    Spasticity;   

Others  :  807688
DOI  :  10.1186/1745-6215-15-12

 received in 2013-11-05, accepted in 2013-12-18,  发布年份 2014

【 摘 要 】

Background

Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications.

Methods/Design

This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.

The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test - a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain.

Trial registrations

ISRCTN57435427, EudraCT2010-021257-39, NCT01882556

【 授权许可】

   
2014 Lindsay et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Stroke Working Party: National clinical guideline for stroke. 3rd edition. London: RCP Publications; 2012.
• [2]Pandyan AD, Gregoric M, Barnes MP, Wood D, Wijck F, Burridge J, Hermens H, Johnson GR: Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil 2005, 27:2-6.
• [3]Gladman JR, Sackley CM: The scope for rehabilitation in severely disabled stroke patients. Disabil Rehabil 1998, 20:391-394.
• [4]Feys H, De Weerdt W, Nuyens G, Van De Winckel A, Selz B, Kiekens C: Predicting motor recovery of the upper limb after stroke rehabilitation: value of a clinical examination. Physiother Res Int 2000, 5:1-18.
• [5]Pandyan AD, Cameron M, Powell J, Stott DJ, Granat MH: Contractures in the post-stroke wrist: a pilot study of its time course of development and its association with upper limb recovery. Clin Rehabil 2003, 17:88-95.
• [6]Barnes MP: An overview of the clinical management of spasticity. In Upper motor neurone syndrome and spasticity: clinical management and neurophysiology. Edited by Barnes MP, Johnson GR. Cambridge: Cambridge University Press; 2008.
• [7]Lieber RL, Steinman S, Barash IA, Chambers H: Structural and functional changes in spastic skeletal muscle. Muscle Nerve 2004, 29:615-627.
• [8]Lyle RC: A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res 1981, 4:483-492.
• [9]Yozbatiran N, Der-Yeghiaian L, Cramer SC: A standardized approach to performing the action research arm test. Neurorehabil Neural Repair 2008, 22:78-90.
• [10]Hermens HJ, Freriks B, Merletti R, Stegeman D, Blok J, Rau G, Disselhorst-Klug C, Hagg G: European Recommendations for Surface Electromyography. The Netherlands: Roessingh Research and Development; 1999.
• [11]Malhotra S, Cousins E, Ward A, Day C, Jones P, Roffe C, Pandyan AD: An investigation into the agreement between clinical, biomechanical and neurophysiological measures of spasticity. Clin Rehabil 2008, 22:1105-1115.
• [12]Cousins E, Ward A, Roffe C, Rimington L, Pandyan A: Does low-dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomized controlled pilot study to estimate effect size. Clin Rehabil 2010, 24:501-513.
• [13]Mahoney FI, Barthel DW: Functional evaluation: the Barthel index. Md State Med J 1965, 14:61-65.
• [14]Robinson BC: Validation of a caregiver strain index. J Gerontol 1983, 38:344-348.
• [15]International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication. 2010. [http://www.icmje.org/urm_full.pdf webcite]