Effect of Repeated Injections of Higher Doses of Botulinum Toxin on Lower Limb of Spastic Hemiplegic Patients on Gait.

Summary

1. To show that repeated injections of higher doses of botulinum toxin are significantly more effective than the injection of unique, lower doses, on gait function. 2. To describe the effect of repeated injections of botulinum toxin on the muscle structure in terms of volume, fat accumulation and fibrosis, by means of MRI studies

Timeline

Start

2018-09-13

Primary completion

2021-12-31

Completion

2021-12-31

Outcome

Met primary endpoint

paper Activities remained stable after the 1st injection but improved after the 2nd and 3rd cycles on the 6MWT (+0.07 and +0.12 m/s, respectively, p < 0.05) PMID 40135684 ↗

Publications

• Background Corriveau H, Hebert R, Raiche M, Dubois MF, Prince F. Postural stability in the elderly: empirical confirmation of a theoretical model. Arch Gerontol Geriatr. 2004 Sep-Oct;39(2):163-77. doi: 10.1016/j.archger.2004.03.001.
• Background Hirvensalo M, Rantanen T, Heikkinen E. Mobility difficulties and physical activity as predictors of mortality and loss of independence in the community-living older population. J Am Geriatr Soc. 2000 May;48(5):493-8. doi: 10.1111/j.1532-5415.2000.tb04994.x.
• Background Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.
• Background Pinzur MS, Sherman R, DiMonte-Levine P, Trimble J. Gait changes in adult onset hemiplegia. Am J Phys Med. 1987 Oct;66(5):228-37.
• Background Olney SJ, Griffin MP, McBride ID. Temporal, kinematic, and kinetic variables related to gait speed in subjects with hemiplegia: a regression approach. Phys Ther. 1994 Sep;74(9):872-85. doi: 10.1093/ptj/74.9.872.
• Background Stoquart G, Detrembleur C, Lejeune TM. The reasons why stroke patients expend so much energy to walk slowly. Gait Posture. 2012 Jul;36(3):409-13. doi: 10.1016/j.gaitpost.2012.03.019. Epub 2012 May 1.
• Background Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
• Background Wissel J, Bensmail D, Ferreira JJ, Molteni F, Satkunam L, Moraleda S, Rekand T, McGuire J, Scheschonka A, Flatau-Baque B, Simon O, Rochford ET, Dressler D, Simpson DM; TOWER study investigators. Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study. Neurology. 2017 Apr 4;88(14):1321-1328. doi: 10.1212/WNL.0000000000003789. Epub 2017 Mar 10.
• Background Minamoto VB, Suzuki KP, Bremner SN, Lieber RL, Ward SR. Dramatic changes in muscle contractile and structural properties after 2 botulinum toxin injections. Muscle Nerve. 2015 Oct;52(4):649-57. doi: 10.1002/mus.24576. Epub 2015 Jun 30.
• Selves C, Dehem S, Lejeune T, Deltombe T, Stoquart G. Effects of 3 Cycles of Increasing Botulinum Toxin Doses on Functional Parameters of Post-stroke Spastic Gait: A Prospective Cohort Study. NeuroRehabilitation. 2025 Mar;56(2):175-185. doi: 10.1177/10538135241303343. Epub 2024 Dec 24.

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