Effect of Repeated Injections of Higher Doses of Botulinum Toxin on Lower Limb of Spastic Hemiplegic Patients on Gait.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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
    

Detailed description: 
      1. A prospective, interventional, multi-centre, open-labeled study will be carried out.
           Sixty stroke patients will be recruited (from the Rehabilitation Ward of Cliniques
           Universitaires Saint-Luc (UCLouvain), or Centre Hospitalier Universitaire de Mont
           Godinne (UCLouvain), or in the out-patients clinic), if they have an indication for
           focal chemical denervation (by botulinum toxin injections) to treat lower limb
           hyper-resistance (spasticity).

           Inclusion criteria: adults (>18 years old), 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.

           Exclusion criteria: aphasia or major cognitive impairments limiting the functional
           evaluation, neurological or orthopedic affections interfering with the studied lower
           limb's function, BONT injections on the lower limb during the last 3 months,
           contraindication to BONT injections (underlying neuromuscular disease) and no
           contraindication to undergo an MRI study.

           Patients will benefit from 3 sessions of botulinum toxin (Xeomeen) injections at 3
           months intervals. During the first session, 400 U of Xeomeen will be injected in the
           lower limb of the patient (and upper limb, if needed). During the second session, 600U
           of Xeomeen will be injected and during the third session, 800Units of Xeomeen will be
           injected (in the lower limb of the patient-and upper limb, if needed-). The injections
           will be based on the clinical evaluation carried out by one of the investigators, who
           are medical doctors, specialized in Physical and Rehabilitation Medicine and have
           experience with hyper-resistance treatment with botulinum toxin.

           Patients will be evaluated just before, a month later and 3 months after each injection
           session. Functional evaluations are based on the ICF model. Impairment will be evaluated
           by the clinical examination (range of motion -ROM- with a hand goniometer, MAS and
           Tardieu scale for spasticity, Fugl-Meyer test for motor control)20; by functional
           evaluations (10 meters walk test, 6 minutes walk test, timed up and down the stairs
           test, Timed Up and Go Test) and by a 3D-Quantified Gait Analysis. The limitations in
           activities of daily life will be evaluated by means of the ABILOCO questionnaire.
           Quality of life (QoL) will be evaluated with the French version of the Short-Form Health
           Survey SF-3624.

        2. To describe the effect of repeated injections of botulinum toxin (Xeomeen) on the muscle
           structure in terms of volume, fat accumulation and fibrosis, a lower limb MRI will be
           performed before, 1-3 days and 1 month after the 1st Xeomeen injection, and 1 month
           after the 3rd BONT injection, for 4 MRI studies per patient. Twenty hemiplegic subjects
           will be recruited. They will participate to the complete study protocol, as described
           for our first objective. Inclusion and exclusion criteria will be the same as previously
           described.

      Statistical analysis: The effects of treatment on continuous variables will be assessed by a
      one-way (time) repeated-measures analysis of variance (Anova). Ordinal data will be assessed
      by a non-parametric analysis. A Chi2 test will be used to compare the distributions of
      qualitative variables. Testing will be performed with a p-value <0,05.
    

Intervention name(s): Xeomin Injectable Product
Intervention type(s): Drug
Intervention description(s): Intramuscular injection
Intervention MeSH terms: incobotulinumtoxinA
Intervention model: Single Group Assignment
Intervention model description: prospective, interventional, multi-centre, open-labeled study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; botulinum neurotoxin; spasticity; hyper-resistance; MRI; muscle structure; gait rehabilitation