RecruitingNot ApplicableNCT03783572

Upper-limb Active Function and Botulinum Toxin a

Sponsor

University Hospital, Toulouse

Enrollment

80 participants

Start Date

Dec 8, 2020

Study Type

INTERVENTIONAL

Conditions

Muscle Spasticity Stroke Upper Extremity Paralysis

Summary

This study in an observational, prospective and longitudinal study. The aim of the study is to evaluate the effect of botulinum toxin type A (BTX) injections into the elbow flexors on the reduction of spastic co-contractions (spastic co-contraction index, SCCI) during an active elbow extension in chronic post-stroke patients.TBA injections are performed as part of routine care

Eligibility

Min Age: 18 Years

Inclusion Criteria12

Stroke group :
Cortical and/or subcortical ischemic or haemorrhagic stroke for at least 6 months;
Indication to an injection of BTA in the elbow flexor muscles according to the usual clinical criteria: request of elbow extension improvement with a functional or aesthetic objective;
Being under prescription of abobotulinum toxin A (DYSPORT®, Ipsen-Pharma);
Ability of active elbow extension\> 20 degrees;
Limitation of active movement of elbow extension \> 15 degrees or decreased or 50% decrease in the active elbow extension rate;
Patients who have never been treated with BTX or only a first injection that having targeted the elbow flexors more than 4 months ago;
Age\> 18 years;
Signature of informed consent;
Subject affiliated to the social security coverture.
Age\> 18 years
Signature of informed consent.

Exclusion Criteria17

Passive limitation of elbow extension \> 30 degrees;
Pain during active movements of elbow flexion/extension;
Cognitive disorder with limited comprehension of three basic instructions (like the test of the 3 papers of the MMS);
Evolutionary or decompensated neurological disease;
Unstabilized epilepsy;
Anticoagulant treatment with a curative dose or hemostasis disorder that contraindicates intramuscular injections;
Claustrophobia or metallic foreign bodies contraindicated for MRI;
General contraindication for botulinum toxin injection: hypersensitivity to the active substance or to one of the excipients, swallowing disorder, chronic respiratory disorders, antecedent of myasthenia or Lambert Eaton syndrome; antecedent of neuromuscular disease; surgery with curarization for less than a month; current treatment with aminoglycoside, aminoquinoline, cyclosporine or anticholinesterase.
Presence of skin infection or inflammation at the injection site.
Legal incapacity.
Pregnant or breastfeeding woman;
Woman with a desire to become pregnant within 18 months.
Non-menopausal woman (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause) who does not use one of the following contraceptive methods considered highly effective : intrauterine device, oestroprogestonic contraception or progestogen hormonal contraception associated with inhibition of ovulation, intrauterine hormone-releasing system, or bilateral tubal occlusion.
Control group
History of orthopedic or neurologic disorders;
Subject expert in a sport intensively requiring the upper limbs (at least departmental competition level);
Legal incapacity.

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Interventions

OTHERClinical evaluation

For the control group : only one clinical evaluation : search for non-inclusion criteria and manual laterality score

OTHERClinical evaluation and Instrumental evaluation

For the patient : The standard clinical examination to evaluate movement : pain, motive power, spasticity plus Edinburgh's laterality score and Sensitivity deficiency by the Erasmus Nottingham Sensory Assessment (EmNSA) score and the evaluation of the cognitive function An encephalic MRI An instrumental evaluation : with concomitant recording of 3D kinematic data, surface and intramuscular EMG of the flexor and elbow extensor muscles, and EEG during active elbow extension, paretic and non-paretic movements.