Do randomised controlled trials evaluating functional outcomes following botulinum neurotoxin-A align with focal spasticity guidelines? A systematic review

References

• Himmelmann K, Beckung E, Hagberg G, et al. Bilateral spastic cerebral palsy-prevalence through four decades, motor function and growth. Eur J Paediatr Neurol. 2007;11(4):215–222.
   PubMed Web of Science ®Google Scholar
• Rizzo MA, Hadjimichael OC, Preiningerova J, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004;10(5):589–595.
   PubMed Web of Science ®Google Scholar
• Urban PP, Wolf T, Uebele M, et al. Occurence and clinical predictors of spasticity after ischemic stroke. Stroke. 2010;41(9):2016–2020.
   PubMed Web of Science ®Google Scholar
• LundströM E, Smits A, Borg J, et al. Four-fold increase in direct costs of stroke survivors with spasticity compared with stroke survivors without spasticity: the first year after the event. Stroke. 2010;41(2):319–324.
   PubMed Web of Science ®Google Scholar
• Teasell R, Foley N, Pereira S, et al. Evidence to practice: botulinum toxin in the treatment of spasticity post stroke. Top Stroke Rehabil. 2012;19(2):115–121.
   PubMed Web of Science ®Google Scholar
• Olver J, Esquenazi A, Fung VS, et al. Botulinum toxin assessment, intervention and aftercare for lower limb disorders of movement and muscle tone in adults: international consensus statement. Eur J Neurol. 2010;17(2):57–73.
   PubMedGoogle Scholar
• Royal College of Physicians BSoRM. Spasticity in adults: management using botulinum toxin. National guidelines. London (UK): RCP; 2018.
   Google Scholar
• Cusick A, Lannin N, Kinnear BZ. Upper limb spasticity management for patients who have received botulinum toxin a injection: Australian therapy practice. Aust Occup Ther J. 2015;62(1):27–40.
   PubMed Web of Science ®Google Scholar
• Olver J, Esquenazi A, Fung VSC, et al. Botulinum toxin assessment, intervention and aftercare for lower limb disorders of movement and muscle tone in adults: international consensus statement. Euro J Neurol. 2010;17(2):57–73.
   PubMedGoogle Scholar
• Heart and Stroke Foundation. Evidence-based review of stroke rehabilitation. 2018. Available from: http://www.ebrsr.com
   Google Scholar
• Williams G, Singer BJ, Ashford S, et al. A synthesis and appraisal of clinical practice guidelines, consensus statements and Cochrane systematic reviews for the management of focal spasticity in adults and children. Disabil Rehabil. 2020;5:1–11.
   Google Scholar
• Üstün TB, Organization WH, Kostanjsek N, et al. Measuring health and disability: manual for WHO disability assessment schedule WHODAS 2.0. Geneva (Switzerland): World Health Organization; 2010.
   Google Scholar
• Cieza A, Fayed N, Bickenbach J, et al. Refinements of the ICF linking rules to strengthen their potential for establishing comparability of health information. Disabil Rehabil. 2019;41(5):574–583.
   PubMed Web of Science ®Google Scholar
• Sussmilch-Leitch SP, Collins NJ, Bialocerkowski AE, et al. Physical therapies for Achilles tendinopathy: systematic review and meta-analysis. J Foot Ankle Res. 2012;5(1):15.
   PubMedGoogle Scholar
• Law MC, MacDermid J. Evidence-based rehabilitation: a guide to practice. Thorofare (NJ): SLACK Incorporated; 2014.
   Google Scholar
• Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
   PubMed Web of Science ®Google Scholar
• Copeland L, Edwards P, Thorley M, et al. Botulinum toxin a for nonambulatory children with cerebral palsy: a double blind randomized controlled trial. J Pediatr. 2014;165(1):140.e4–146.e4.
   Web of Science ®Google Scholar
• Slade SC, Dionne CE, Underwood M, et al. Consensus on exercise reporting template (CERT): explanation and elaboration statement. Br J Sports Med. 2016;50(23):1428–1437.
   PubMed Web of Science ®Google Scholar
• Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.
   PubMed Web of Science ®Google Scholar
• Lannin NA, Ada L, Levy T, et al. Intensive therapy after botulinum toxin in adults with spasticity after stroke versus botulinum toxin alone or therapy alone: a pilot, feasibility randomized trial. Pilot Feasibility Stud. 2018;4:82.
   PubMedGoogle Scholar
• Shaw L, Rodgers H, Price C, et al. BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A. Health Technol Assess. 2010;14(26):1–113.
   PubMed Web of Science ®Google Scholar
• Baricich A, Picelli A, Carda S, et al. Electrical stimulation of antagonist muscles after botulinum toxin type a for post-stroke spastic equinus foot. A randomized single-blind pilot study. Ann Phys Rehabil Med. 2019;62(4):214–219.
   PubMed Web of Science ®Google Scholar
• Cinone N, Letizia S, Santoro L, et al. Combined effects of isokinetic training and botulinum toxin type a on spastic equinus foot in patients with chronic stroke: a pilot, single-blind, randomized controlled trial. Toxins. 2019;11(4):210.
   PubMed Web of Science ®Google Scholar
• Maanum G, Jahnsen R, Stanghelle JK, et al. Effects of botulinum toxin a in ambulant adults with spastic cerebral palsy: a randomized double-blind placebo controlled-trial. J Rehabil Med. 2011;43(4):338–347.
   PubMed Web of Science ®Google Scholar
• Santamato A, Micello MF, Panza F, et al. Adhesive taping vs. daily manual muscle stretching and splinting after botulinum toxin type a injection for wrist and fingers spastic overactivity in stroke patients: a randomized controlled trial. Clin Rehabil. 2015;29(1):50–58.
   PubMed Web of Science ®Google Scholar
• Wu YT, Yu HK, Chen LR, et al. Extracorporeal shock waves versus botulinum toxin type a in the treatment of poststroke upper limb spasticity: a randomized noninferiority trial. Arch Phys Med Rehabil. 2018;99(11):2143–2150.
   PubMed Web of Science ®Google Scholar
• Zeuner KE, Knutzen A, Kühl C, et al. Functional impact of different muscle localization techniques for botulinum neurotoxin a injections in clinical routine management of post-stroke spasticity. Brain Inj. 2017;31(1):75–82.
   PubMed Web of Science ®Google Scholar
• Nasb M, Li Z, S.A. Youssef A, et al. Comparison of the effects of modified constraint-induced movement therapy and intensive conventional therapy with a botulinum-a toxin injection on upper limb motor function recovery in patients with stroke. Libyan J Med. 2019;14(1):1609304.
   PubMed Web of Science ®Google Scholar
• Koman LA, Smith BP, Williams R, et al. Upper extremity spasticity in children with cerebral palsy: a randomized, double-blind, placebo-controlled study of the short-term outcomes of treatment with botulinum a toxin. J Hand Surg Am. 2013;38(3):435.e1–446.e1.
   Google Scholar
• Lidman G, Nachemson A, Peny-Dahlstrand M, et al. Botulinum toxin a injections and occupational therapy in children with unilateral spastic cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2015;57(8):754–761.
   PubMed Web of Science ®Google Scholar
• Picelli A, La Marchina E, Gajofatto F, et al. Sonographic and clinical effects of botulinum toxin type a combined with extracorporeal shock wave therapy on spastic muscles of children with cerebral palsy. Dev Neurorehabil. 2017;20(3):160–164.
   PubMed Web of Science ®Google Scholar
• Thomas RE, Johnston LM, Sakzewski L, et al. Evaluation of group versus individual physiotherapy following lower limb intra-muscular botulinum toxin-type A injections for ambulant children with cerebral palsy: a single-blind randomized comparison trial. Res Dev Disabil. 2016;53–54:267–278.
   PubMed Web of Science ®Google Scholar
• Lannin NA, Ada L, English C, et al. Effect of additional rehabilitation after botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE trial. Stroke. 2020;51(2):556–562.
   PubMed Web of Science ®Google Scholar
• Stroke Unit Trialists’ Collaboration. Organised inpatient (stroke unit) care for stroke. Cochrane Database Syst Rev. 2007;17(4):CD000197.
   Google Scholar
• Prazeres A, Lira M, Aguiar P, et al. Efficacy of physical therapy associated with botulinum toxin type a on functional performance in post-stroke spasticity: a randomized, double-blinded, placebo-controlled trial. Neurol Int. 2018;10(2):7385.
   PubMed Web of Science ®Google Scholar
• Lam K, Lau KK, So KK, et al. Can botulinum toxin decrease carer burden in long term care residents with upper limb spasticity? A randomized controlled study. J Am Med Directors Assoc. 2012;13(5):477–484.
   PubMed Web of Science ®Google Scholar
• Hoare B, Imms C, Villanueva E, et al. Intensive therapy following upper limb botulinum toxin a injection in young children with unilateral cerebral palsy: a randomized trial. Dev Med Child Neurol. 2013;55(3):238–247.
   PubMed Web of Science ®Google Scholar
• Ward AB, Wissel J, Borg J, et al. Functional goal achievement in post-stroke spasticity patients: the BOTOX® economic spasticity trial (BEST). J Rehabil Med. 2014;46(6):504–513.
   PubMed Web of Science ®Google Scholar
• Delgado MR, Tilton A, Russman B, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: a randomized controlled trial. Pediatrics. 2016;137(2):e20152830.
   PubMed Web of Science ®Google Scholar
• Tilton A, Russman B, Aydin R, et al. AbobotulinumtoxinA (Dysport®) improves function according to goal attainment in children with dynamic equinus due to cerebral palsy. J Child Neurol. 2017;32(5):482–487.
   PubMed Web of Science ®Google Scholar
• Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004;75(7):951–957.
   PubMed Web of Science ®Google Scholar
• Patrick E, Ada L. The Tardieu scale differentiates contracture from spasticity whereas the ashworth scale is confounded by it. Clin Rehabil. 2006;20(2):173–182.
   PubMed Web of Science ®Google Scholar
• Akpinar P, Atici A, Ozkan FU, et al. Reliability of the modified Ashworth scale and modified Tardieu scale in patients with spinal cord injuries. Spinal Cord. 2017;55(10):944–949.
   PubMed Web of Science ®Google Scholar
• Mehrholz J, Wagner K, Meißner D, et al. Reliability of the modified Tardieu scale and the modified Ashworth scale in adult patients with severe brain injury: a comparison study. Clin Rehabil. 2005;19(7):751–759.
   PubMed Web of Science ®Google Scholar
• Milinis K, Young CA. Systematic review of the influence of spasticity on quality of life in adults with chronic neurological conditions. Disabil Rehabil. 2016;38(15):1431–1441.
   PubMed Web of Science ®Google Scholar
• Wolf SL, Milton SB, Reiss A, et al. Further assessment to determine the additive effect of botulinum toxin type a on an upper extremity exercise program to enhance function among individuals with chronic stroke but extensor capability. Arch Phys Med Rehabil. 2012;93(4):578–587.
   PubMed Web of Science ®Google Scholar
• Tedroff K, Löwing K, Haglund-Akerlind Y, et al. Botulinum toxin a treatment in toddlers with cerebral palsy. Acta Paediatr. 2010;99(8):1156–1162.
   PubMed Web of Science ®Google Scholar
• Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009;23(4):362–370.
   PubMed Web of Science ®Google Scholar
• Carda S, Invernizzi M, Baricich A, et al. Casting, taping or stretching after botulinum toxin type a for spastic equinus foot: a single-blind randomized trial on adult stroke patients. Clin Rehabil. 2011;25(12):1119–1127.
   PubMed Web of Science ®Google Scholar
• ICF Research Branch. ICF core set for hand conditions. 2017. Available from: https://www.icf-research-branch.org/icf-core-sets
   Google Scholar
• Bernhardt J, Borschmann KN, Kwakkel G, et al. Setting the scene for the second stroke recovery and rehabilitation roundtable. Int J Stroke. 2019;14(5):450–456.
   PubMed Web of Science ®Google Scholar
• Erbil D, Tugba G, Murat TH, et al. Effects of robot-assisted gait training in chronic stroke patients treated by botulinum toxin-a: a pivotal study. Physiother Res Int. 2018;23(3):e1718.
   PubMed Web of Science ®Google Scholar
• Wallace AC, Talelli P, Crook L, et al. Exploratory randomized Double-Blind Placebo-Controlled trial of botulinum therapy on grasp release after stroke (PrOMBiS). Neurorehabil Neural Repair. 2020;34(1):51–60.
   PubMed Web of Science ®Google Scholar
• Ferrari A, Maoret AR, Muzzini S, et al. A randomized trial of upper limb botulimun toxin versus placebo injection, combined with physiotherapy, in children with hemiplegia. Res Dev Disabil. 2014;35(10):2505–2513.
   PubMed Web of Science ®Google Scholar
• Williams SA, Elliott C, Valentine J, et al. Combining strength training and botulinum neurotoxin intervention in children with cerebral palsy: the impact on muscle morphology and strength. Disabil Rehabil. 2013;35(7):596–605.
   PubMed Web of Science ®Google Scholar
• Çağlar Okur S, Uğur M, Şenel K. Effects of botulinum toxin a injection on ambulation capacity in patients with cerebral palsy. Dev Neurorehabil. 2019;22(4):288–291.
   PubMed Web of Science ®Google Scholar
• Devier D, Harnar J, Lopez L, et al. Rehabilitation plus OnabotulinumtoxinA improves motor function over OnabotulinumtoxinA alone in post-stroke upper limb spasticity: a single-blind, randomized trial. Toxins. 2017;9(7):216.
   PubMed Web of Science ®Google Scholar
• Ding XD, Zhang GB, Chen HX, et al. Color doppler ultrasound-guided botulinum toxin type a injection combined with an ankle foot brace for treating lower limb spasticity after a stroke. Eur Rev Med Pharmacol Sci. 2015;19(3):406–411.
   PubMed Web of Science ®Google Scholar
• Gandolfi M, Valè N, Dimitrova EK, et al. Effectiveness of robot-assisted upper limb training on spasticity, function and muscle activity in chronic stroke patients treated with botulinum toxin: a randomized single-blinded controlled trial. Front Neurol. 2019;10(41):41.
   PubMedGoogle Scholar
• Karadag-Saygi E, Cubukcu-Aydoseli K, Kablan N, et al. The role of kinesiotaping combined with botulinum toxin to reduce plantar flexors spasticity after stroke. Top Stroke Rehabil. 2010;17(4):318–322.
   PubMed Web of Science ®Google Scholar
• Paoloni M, Giovannelli M, Mangone M, et al. Does giving segmental muscle vibration alter the response to botulinum toxin injections in the treatment of spasticity in people with multiple sclerosis? A single-blind randomized controlled trial. Clin Rehabil. 2013;27(9):803–812.
   PubMed Web of Science ®Google Scholar
• Pennati GV, Da Re C, Messineo I, et al. How could robotic training and botolinum toxin be combined in chronic post stroke upper limb spasticity? A pilot study. Eur J Phys Rehabil Med. 2015;51(4):381–387.
   PubMed Web of Science ®Google Scholar
• Picelli A, Bacciga M, Melotti C, et al. Combined effects of robot-assisted gait training and botulinum toxin type a on spastic equinus foot in patients with chronic stroke: a pilot, single blind, randomized controlled trial. Eur J Phys Rehabil Med. 2016;52(6):759–766.
   PubMed Web of Science ®Google Scholar
• Picelli A, Dambruoso F, Bronzato M, et al. Efficacy of therapeutic ultrasound and transcutaneous electrical nerve stimulation compared with botulinum toxin type a in the treatment of spastic equinus in adults with chronic stroke: a pilot randomized controlled trial. Top Stroke Rehabil. 2014;21(1):S8–S16.
   PubMedGoogle Scholar
• Roche N, Zory R, Sauthier A, et al. Effect of rehabilitation and botulinum toxin injection on gait in chronic stroke patients: a randomized controlled study. J Rehabil Med. 2015;47(1):31–37.
   PubMed Web of Science ®Google Scholar
• Santamato A, Notarnicola A, Panza F, et al. SBOTE study: extracorporeal shock wave therapy versus electrical stimulation after botulinum toxin type a injection for post-stroke spasticity-a prospective randomized trial. Ultrasound Med Biol. 2013;39(2):283–291.
   PubMed Web of Science ®Google Scholar
• Sun SF, Hsu CW, Sun HP, et al. Combined botulinum toxin type a with modified constraint-induced movement therapy for chronic stroke patients with upper extremity spasticity: a randomized controlled study. Neurorehabil Neural Repair. 2010;24(1):34–41.
   PubMed Web of Science ®Google Scholar
• Weber DJ, Skidmore ER, Niyonkuru C, et al. Cyclic functional electrical stimulation does not enhance gains in hand grasp function when used as an adjunct to onabotulinumtoxinA and task practice therapy: a single-blind, randomized controlled pilot study. Arch Phys Med Rehabil. 2010;91(5):679–686.
   PubMed Web of Science ®Google Scholar
• Abramovich SG, Drobyshev VA, Pyatova AE, et al. Comprehensive use of dynamic electrical neurostimulation and botulinum toxin therapy in patients with post-stroke spasticity. J Stroke Cerebrovasc Dis. 2020;29(11):105189.
   PubMed Web of Science ®Google Scholar
• Giray E, Gencer Atalay K, Eren N, et al. Effects of dynamic lycra orthosis as an adjunct to rehabilitation after botulinum toxin-A injection of the upper-limb in adults following stroke: a single-blinded randomized controlled pilot study. Top Stroke Rehabil. 2020;27(6):473–481.
   PubMed Web of Science ®Google Scholar
• Leung J, King C, Fereday S. Effectiveness of a programme comprising serial casting, botulinum toxin, splinting and motor training for contracture management: a randomized controlled trial. Clin Rehabil. 2019;33(6):1035–1044.
   PubMed Web of Science ®Google Scholar
• Munari D, Serina A, Disarò J, et al. Combined effects of backward treadmill training and botulinum toxin type a therapy on gait and balance in patients with chronic stroke: a pilot, single-blind, randomized controlled trial. NeuroRehabilitation. 2020;46(4):519–528.
   PubMed Web of Science ®Google Scholar
• Bandholm T, Jensen BR, Nielsen LM, et al. Neurorehabilitation with versus without resistance training after botulinum toxin treatment in children with cerebral palsy: a randomized pilot study. NRE. 2012;30(4):277–286.
   Google Scholar
• Dai AI, Demiryürek AT. Serial casting as an adjunct to botulinum toxin type a treatment in children with cerebral palsy and spastic paraparesis with scissoring of the lower extremities. J Child Neurol. 2017;32(7):671–675.
   PubMed Web of Science ®Google Scholar
• Dursun N, Gokbel T, Akarsu M, et al. Randomized controlled trial on effectiveness of intermittent serial casting on spastic equinus foot in children with cerebral palsy after botulinum toxin-A treatment. Am J Phys Med Rehabil. 2017;96(4):221–225.
   PubMed Web of Science ®Google Scholar
• Kelly B, MacKay-Lyons M, Berryman S, et al. Casting protocols following BoNT-a injections to treat spastic hypertonia of the triceps surae in children with cerebral palsy and equinus gait: a randomized controlled trial. Phys Occup Ther Pediatr. 2019;39(1):77–93.
   PubMed Web of Science ®Google Scholar
• Pieber K, Herceg M, Wick F, et al. Functional electrical stimulation combined with botulinum toxin type a to improve hand function in children with spastic hemiparesis - a pilot study. Wien Klin Wochenschr. 2011;123(3–4):100–105.
   PubMed Web of Science ®Google Scholar
• Preston N, Weightman A, Gallagher J, et al. A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy. Clin Rehabil. 2016;30(10):1004–1015.
   PubMed Web of Science ®Google Scholar
• Yiğitoğlu P, Kozanoğlu E. Effectiveness of electrical stimulation after administration of botulinum toxin in children with spastic diplegic cerebral palsy: a prospective, randomized clinical study. Turk J Phys Med Rehab. 2019;65(1):16–23.
   PubMed Web of Science ®Google Scholar