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

NCT04544280 | Completed

• 1 other identifier: 2018-18 mai-217
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

1. 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. 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

Conditions

Stroke

Keywords

stroke; botulinum neurotoxin; spasticity; hyper-resistance; MRI; muscle structure; gait rehabilitation

Outcome Measures

Primary Outcomes (1)

• Temporo-spatial parameters of gait

  Improvement of temporo-spatial parameters of gait as assessed by quantified gait analysis

  7-9 months

Secondary Outcomes (3)

• Segmental kinematics of gait

  7-9 months

• Energetic parameters

  7-9 months

• Muscle structure

  7-9 months

Study Arms (1)

Intervention

EXPERIMENTAL

Drug: Xeomin Injectable Product

Interventions

Xeomin Injectable Product DRUG

Intramuscular injection

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemiparesis secondary to stroke, date of stroke\>3 months ago, lower limb hyper resistance responsible of gait impairment, focal chemical denervation indication, ability to walk on a treadmill

You may not qualify if:

• aphasia or major cognitive impairments limiting the functional evaluation, neurological or orthopedic affections interfering with the studied lower limb's function, botulinum toxin injections on the lower limb during the last 3 months, contraindication to botulinum toxin injections (underlying neuromuscular disease) and no contraindication to undergo an MRI study.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (2)

Cliniques Universitaire Saint Luc

Brussels, 1200, Belgium

Location

Cliniques Universitaires UCL Mont-Godinne

Yvoir, 5530, Belgium

Location

Related Publications (10)

• 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.

  PMID: 15249153 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.

  PMID: 10811541 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.

  PMID: 6661021 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.

  PMID: 3324770 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.

  PMID: 8066114 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.

  PMID: 22555062 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.

  PMID: 18635841 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.

  PMID: 28283596 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.

  PMID: 25598004 BACKGROUND

• 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.

  PMID: 40135684 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity

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

Study Officials

• Gaëtan STOQUART, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, interventional, multi-centre, open-labeled study.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: September 13, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)