NCT Number: NCT05874154
In France, more than 110.000 patients are hospitalized for stroke per year. It is the leading cause of sudden disabilities in adults. Incidence of spastic foot is evaluated at 1 year post stroke from 18% to 56% of hemiplegic patients. Spasticity, defined as an increase in the velocity-dependent response to muscle stretch measured at rest, is part of the upper motor neuron syndrome and is characterized by an increase in tonic stretch reflex. It has been proposed that upper motor neuro syndrome may induce not only spasticity but also other types of muscles overactivity such as spastic dystonia, co-contraction and clonus. In hemiplegic patients, lower limb spasticity within the posterior part of the leg frequently results in equino-varus foot and toes claw. These abnormal postures in hemiplegics may affect activities of daily living such as shoes fitting, balance, ambulation-walking, comfort (pain) and may become irreducible (tendon shortening) if not treated.
The purpose of this study is to compare the interest of each treatment (BoNT-A versus STN) in order to specify both techniques indications and up-date current guidelines of lower-limb spasticity for hemiplegic patients.
This study aims to confirm a greater reduction of calf muscles spasticity after STN as compared to BoNT-A, as observed in the only published monocentric randomized controlled trial. Our study originality is to perform a multi-center RCT with a pre-established sample size. This study will also quantify progress towards personal goals using the goal attainment scaling (GAS) and will assess other components related to the consequences of carve muscle spasticity on balance, ambulation, self-care and quality of life.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Hôpital Pierre Wertheimer, Bron, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the STN group will undergo a pre-anaesthetic visit before surgery to validate the possibility of general anesthesia. The surgery will be performed at maximum 3 months after inclusion. The muscles that have been defined pre-randomization will be targeted by the surgery. The duration of the surgery is about 1 hour and 30 minutes.
Patients in the BoNT group will be treated with BoNT A under electromyography, electrical stimulation and/or ultrasound guidance (V0). In the absence of scientific evidence between the efficacy of onabotulinumtoxin A and abobotulinumtoxin A, physician will be free to choose between these two BoNT formulation which are both authorized for the treatment of lower limb spasticity. The physician will determine the muscles targeted by the BoNT (gastrocnemius and soleus for equinus, posterior tibialis for varus, and long flexor digitorum and flexor hallucis for claw toes), the appropriate dose and dilution based on his experience, following a semi-guided table of equivalence for respective doses of onabotulinumtoxin A and abobotulinumtoxin A. A delay superior to 3 months will be respected after the last injection and the muscles that have been defined pre-randomization will be targeted by injections.
Time frame: through study completion, 14 months
Primary endpoint will be assessed using the Goal Attainment Scaling before treatment and the evaluation at the endpoint. Goals are defined before initiation of treatment, and attainment at study end is scored using a 5-point scale (-2, -1, 0, 1, 2); -2: pretreatment level, -1: less than expected; 0: expected goal; +1: somewhat more than expected; +2: best possible outcome expected
Time frame: through study completion, 14 months
Functional outcomes before treatment, at 5 weeks using Goal Attainment Scaling primary outcome scoring
Time frame: through study completion, 14 months
Tardieu's scale assesses spasticity with movement velocity, muscle reaction angle and quality.
Time frame: through study completion, 14 months
-Modified Ashworth scale, measures spasticity level according to a level scale (0,1,1+,2,3,4), 0=absence of muscle tone increase and 4=rigidity in flexion or extension of affected part(s)
Time frame: through study completion, 14 months
Active and/or passive ankle motion range Improvement at 5 weeks and endpoint
Time frame: through study completion, 14 months
Time frame: through study completion, 14 months
Pain type using a self-rating scale for estimating the likelihood of neuropathic painscale before treatment (named DN4), at 5 weeks and endpoint using a 0 to 10 visual analogic scale
Time frame: through study completion, 14 months
Adverse effects by systematic assessment at 5 weeks and endpoint.
Time frame: through study completion, 14 months
Patient reported Experience Measures will be assessed at endpoint with the CSQ-8 questionnaire
Time frame: through study completion, 14 months
Walking speed with the 10 meter walk test (10MWT)
Time frame: through study completion, 14 months
distance improvement assessed using the 6 minutes walking test (6MWT)
Contact information is provided by the study sponsor or research team.
Anne-Laure CHARLOIS
CONTACT
Jacques LUAUTE, MD,PhD
CONTACT
Hospices Civils de Lyon
Other
Acronym: FOOTNEUROTOX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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