Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients

Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients Randomized Controlled Trial Versus Placebo

Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin injections with respect to limitations of gait activities are still discussed. The aim of this study is to to investigate the effects of intramuscular Botulinum toxin type A injections on quantitative gait parameters (gait speed, step length and width, single support time) and posture, in hemiparetic post stroke patients with lower limb spasticity.

Study Overview

• Status: Completed
• Conditions: Spastic Equinovarus Foot
• Intervention / Treatment: Drug: Intra muscular injection of Botulinum toxin

Detailed Description

Multicenter, randomized, active treatment versus placebo, double-blind trial.

Hemiplegia by stroke is the leading cause of disability in adults in France (145 new cases per 100 000 population), a source of locomotor disabilities. The spastic equinovarus foot is the main cause of standing and walking disorders in these patients. Current therapies rely mainly on rehabilitation and equipment care, or for some on surgery. Botulinum toxin A is more and more used in this context. Two randomized studies (double-blind, placebo-controlled) have already demonstrated efficacy in terms of impairment (spasticity assessed using the Ashworth scale), but not in terms of capacity (evaluated from walking speed). ). The ability to maintain standing balance during an attention task and during walking, the study of quality of life have never been studied. But these parameters are important in the approach of the evaluation of such a therapy.

The purpose of the research is to evaluate the efficacy of botulinum toxin A in the treatment of adult post-stroke spastic equine varus foot in terms of: ability to maintain upright balance during an attentional task (main objective), coordination of posture and movement, standing posture, impairments and abilities, or quality of life (secondary objectives). To evaluate the tolerance and the undesirable effects related to the use of the toxin.

Methodology Prospective, comparative and randomized study, active product (botulinum toxin A) versus placebo. Patients will be recruited from the functional rehabilitation clinic. After verification of the inclusion criteria, the pre-therapeutic evaluation will be organized including: double spots, coordination posture and movement, standing posture, deficiencies and abilities, quality of life. The doctor will schedule the therapeutic session within 2 weeks. A second post-treatment evaluation will be carried out at the 4th week of follow-up according to the same scheme. The number of subjects required has been set at 84.

Method Clinical evaluation, posture and gait analysis were performed before injection and 4 to 6 weeks after injection. Quantitative gait parameters (gait speed, step length and width, single support time) were recorded with the Gaitrite walking mat. Posture was recorded with AMTI® forceplate.

Expected results: demonstrate the effectiveness of botulinum toxin on gait and balance First study about effects of botulinum toxin injection on gait parameters registered by a walking mat and objective measure of posture in dual task condition in chronic post stroke patients

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic stroke hemiplegic patients presenting lower limb spasticity
• A minimum 12-month interval since stroke,
• Lower limb spasticity with a Modified Ashworth Scale greater than or equal to 2 on the triceps surae
• Minimum 6-month interval since a previous BTx-A injection
• To be older than 18 years.
• Patients must have an indication of treatment with Botulinum toxin, determined by a Physical and Rehabilitation Medicine specialist, based on clinical examination and gait analysis

Exclusion Criteria:

• Contraindication to the use of botulinum toxin: Myastenia, Lambert Eaton syndrome, ALS, pregnancy, breast-feeding, treatment with aminoglycoside, cyclosporine, previous hypersensitivity to botulinum toxin
• Contraindication to intramuscular injections
• Patients unable to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: botulinum toxin; injection of Botulinum toxin	Drug: Intra muscular injection of Botulinum toxin; posture and gait analysis were performed before injection and 4 to 6 weeks after injection
PLACEBO_COMPARATOR: placebo; Injection of saline serum (placebo)	Drug: Intra muscular injection of Botulinum toxin; posture and gait analysis were performed before injection and 4 to 6 weeks after injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posture	sway area of the center of pressure measured with AMTI® force plate	6 weeks after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait	Walking speed measured with Gaitrite® walking mat	6 weeks after injection

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Publications and helpful links

General Publications

• Kerzoncuf M, Viton JM, Pellas F, Cotinat M, Calmels P, Milhe de Bovis V, Delarque A, Bensoussan L. Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):242-248. doi: 10.1016/j.apmr.2019.04.024. Epub 2019 Aug 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2006
• Primary Completion (ACTUAL): May 18, 2009
• Study Completion (ACTUAL): November 17, 2010

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Congenital Abnormalities; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Musculoskeletal Abnormalities; Muscle Hypertonia; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Muscle Spasticity; Clubfoot; Talipes; Equinus Deformity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 2005-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No