Upper limb international spasticity study: Rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice

BMJ Open

Volumn 3, Issue 3, 2013, Pages

  Turner Stokes, Lynne ^a   Fheodoroff, Klemens ^b   Jacinto, Jorge ^c   Maisonobe, Pascal ^d   Zakine, Benjamin ^d  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b Gailtal Klinik   (Australia)

^c Centro de Medicina de Reabilitacaode Alcoitao   (Portugal)

^d IPSEN   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BOTULINUM TOXIN A;

ADULT; AGED; ARTICLE; CLINICAL PRACTICE; DRUG EFFICACY; FEMALE; GOAL ATTAINMENT; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL EDUCATION; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PHARMACOEPIDEMIOLOGY; PROSPECTIVE STUDY; SPASTICITY; UPPER LIMB INTERNATIONAL SPASTICITY PROGRAM; UPPER LIMB SPASTICITY; VALIDITY;

EID: 84877681909     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-002230     Document Type: Article

References (40)

1. Leathley MJ, Gregson JM, Moore AP, et al. Predicting spasticity after stroke in those surviving to 12 months. Clin Rehabil 2004;18:438-43. (Pubitemid 38697077)
2. Lundstrom E, Terent A, Borg J. Prevalence of disabling spasticity 1 year after first-ever stroke. Eur J Neurol 2008;15:533-9. (Pubitemid 351677501)
3. Sommerfeld DK, Eek EU, Svensson AK, et al. Spasticity after stroke: Its occurrence and association with motor impairments and activity limitations. Stroke 2004;35:134-9. (Pubitemid 38057606)
4. Watkins CL, Leathley MJ, Gregson JM, et al. Prevalence of spasticity post stroke. Clin Rehabil 2002;16:515-22.
5. Welmer AK, von Arbin M, Holmqvist L Widen, et al. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis 2006;21:247-53.
6. Welmer AK, Holmqvist L Widen, Sommerfeld DK. Location and severity of spasticity in the first 1-2 weeks and at 3 and 18 months after stroke. Eur J Neurol 2010;17:720-5.
7. Spasticity in adults: Management using Botulinum Toxin. National guidelines. London: Royal College of Physicians, 2009.
8. Sheean G, Lannin NA, Turner-Stokes L, et al. Botulinum toxin assessment, intervention and after-care for upper limb hypertonicity in adults: International consensus statement. Eur J Neurol 2010; (Suppl 2):74-93.
9. Ward AB. Spasticity treatment with botulinum toxins. J Neural Transm 2008;115:607-16.
10. Bakheit AM, Sawyer J. The effects of botulinum toxin treatment on associated reactions of the upper limb on hemiplegic gait-a pilot study. Disabil Rehabil 2002;24:519-22. (Pubitemid 34823258)
11. Bhakta BB, Cozens JA, Chamberlain MA, et al. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: A randomised double blind placebo controlled trial. (erratum appears in J Neurol Neurosurg Psychiatry 2001 Jun;70(6):821). J Neurol Neurosurg Psychiatr 2000;69:217-21. (Pubitemid 30466027)
12. Bhakta BB, Cozens JA, Bamford JM, et al. Use of botulinum toxin in stroke patients with severe upper limb spasticity. J Neurol Neurosurg Psychiatr 1996;61:30-5. (Pubitemid 26232024)
13. Brashear A, Gordon MF, Elovic E, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. NEJM 2002;347:395-400. (Pubitemid 34851831)
14. Hesse S, Jahnke MT, Luecke D, et al. Short-term electrical stimulation enhances the effectiveness of Botulinum toxin in the treatment of lower limb spasticity in hemiparetic patients. Neurosci Lett 1995;201:37-40.
15. Richardson D, Edwards S, Sheean GL, et al. The effect of botulinum toxin on hand function after incomplete spinal cord injury at the level of C5/6: A case report. Clin Rehabil 1997;11:288-92. (Pubitemid 27489203)
16. Rodriquez AA, McGinn M, Chappell R. Botulinum toxin injection of spastic finger flexors in hemiplegic patients. Am J Phys Med Rehabil 2000;79:44-7. (Pubitemid 30075098)
17. Simpson DM, Alexander DN, O'Brien CF, et al. Botulinum toxin type A in the treatment of upper extremity spasticity: A randomized, double-blind, placebo-controlled trial. Neurology 1996;46:1306-10. (Pubitemid 26159292)
18. Smith SJ, Ellis E, White S, et al. A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil 2000;14:5-13. (Pubitemid 30072216)
19. DeJong G, Horn SD, Conroy B, et al. Opening the black box of post-stroke rehabilitation: Stroke rehabilitation patients, processes, and outcomes. (see comment). Arch Phys Med Rehabil 2005;86:S1-7. (Pubitemid 43040965)
20. Francis HP, Wade DT, Turner-Stokes L, et al. Does reducing spasticity translate into functional benefit? An exploratory meta-analysis. J Neurol Neurosurg Psychiatr 2004;75:1547-51. (Pubitemid 39430605)
21. Turner-Stokes L, Ashford S, Nair A. Physical therapy and botulinum toxin-A (BoNT-A)-the temporal relationship between spasticity reduction and functional gain (AAPMR Annual Assembly Poster 14). Phys Med Rehabil 2010;2:S13-14.
22. Kiresuk T, Sherman R. Goal attainment scaling: A general method of evaluating comprehensive mental health programmes. Community Ment Health J 1968;4:443-53.
23. Ashford S, Turner-Stokes L. Goal attainment for spasticity management using botulinum toxin. Physiother Res Int 2006;11:24-34.
24. Turner-Stokes L, Baguley I, De Graff S, et al. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: A secondary analysis from a double blind placebo controlled randomised clinical trial. J Rehabil Med 2010;42:81-9.
25. McCrory P, Turner-Stokes L, Baguley IJ, et al. Botulinum toxin A for treatment of upper limb spasticity following stroke: A multi-centre randomised placebo-controlled study of the effects on quality of life and other person-centred outcomes. J Rehabil Med 2009;41:536-44.
26. Borg J, Ward AB, Wissel J, et al. Rationale and design of a multicentre, double-blind, prospective, randomized, European and Canadian study: Evaluating patient outcomes and costs of managing adults with post-stroke focal spasticity. J Rehabil Med 2011;43:15-22.
27. Scobbie L, Dixon D, Wyke S. Goal setting and action planning in the rehabilitation setting: Development of a theoretically informed practice framework. Clin Rehabil 2011;25:468-82.
28. Turner-Stokes L. Goal attainment scaling in rehabilitation; a practical guide. Clin Rehabil 2009;23:362-70.
29. Tennant A. Goal attainment scaling: Current methodological challenges. Disabil Rehabil 2007;29:1583-8.
30. Yip AM, Gorman MC, Stadnyk K, et al. A standardized menu for Goal Attainment Scaling in the care of frail elders. Gerontologist 1998;38:735-42. (Pubitemid 29006448)
31. International classification of functioning, disability and health. Geneva: World Health Organisation, 2002: Http://www.who.int/classifications/icf/ en/(accessed Jan 2013)
32. Baguley IJ, Nott MT, Turner-Stokes L, et al. Investigating muscle selection for botulinum toxin-A injections in adults with post-stroke upper limb spasticity. J Rehabil Med 2011;43:1032-7.
33. Horn SD, Gassaway J. Practice-based evidence study design for comparative effectiveness research. Med Care 2007;45: S50-7.
34. Bakheit AM, Zakine B, Maisonobe P, et al. The profile of patients and current practice of treatment of upper limb muscle spasticity with botulinum toxin type A: An international survey. Int J Rehabil Res 2010;33:199-204.
35. Turner-Stokes L, Siegert RJ, Thu A, et al. The neurological impairment scale: A predictor of functional outcome in patients with severe complex disability (AAPMR Annual Assembly Poster 38). Phys Med Rehabil 2011;3:S189.
36. Ashford S, Slade M, Turner-Stokes L. Conceptualisation and development of the arm activity measure (ArmA) for assessment of activity in the hemiparetic arm. Disabil Rehabil 2013. In press. Published Online January 2013.
37. Ashford S, Turner-Stokes L, Siegert RJ, et al. Initial psychometric evaluation of the Arm Activity measure (ArmA)-a measure of active and passive function in the hemiparetic arm. Clin Rehabil. Published online before print 20 February 2013 doi: 10.1177/0269215512474942.
38. Macfarlane A, Turner-Stokes L, De Souza L. The associated reaction rating scale: A clinical tool to measure associated reactions in the hemiplegic upper limb. Clin Rehabil 2002;16:726-35. (Pubitemid 35276572)
39. Turner-Stokes L,Williams H. Goal attainment scaling: A direct comparison of alternative rating methods. Clin Rehabil 2010;24: 66-73.
40. Turner-Stokes L, Fheodoroff K, Jacinto J. Validation of individual person-centered goal statements for goal attainment scaling in a large international cohort study of botulinum toxin type A for upper limb spasticity after stroke. Phys Med Rehabil 2011;3:s338.