Spastic Equinovarus Foot Clinical Trial
Official title:
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00825097 -
Efficacy Study of Selective Tibial Neurotomy in the Treatment of the Spastic Equinovarus Foot Among Adult Hemiplegic Patients
|
Phase 3 |