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

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

Plain Language Summary

Simplified for easier understanding

This study looks at the effects of botulinum toxin type A (Botox) injections on upper limb function in people who have had a stroke. After a stroke, many people develop spasticity — a muscle stiffness in the arm that limits movement and makes everyday activities difficult. Botox is used to relax overactive muscles, but this study specifically looks at whether it also improves active elbow extension (the ability to straighten the arm) and how this relates to brain changes visible on MRI. The study includes a stroke group (receiving Botox injections as part of their standard care) and a healthy control group. For stroke patients, there are detailed criteria about elbow function and Botox history to ensure the right participants are included. You may be eligible if: - You are 18 or older and have had an ischemic or hemorrhagic stroke at least 6 months ago - Your doctor recommends a Botox injection into your elbow flexor muscles - You have at least 20 degrees of active elbow extension - You have limited elbow extension due to spasticity You may NOT be eligible if: - You have severe passive limitation of elbow extension (more than 30 degrees) - You have pain during elbow movement - You have significant cognitive impairment - You are on anticoagulant therapy that prevents intramuscular injections - You are pregnant, breastfeeding, or planning pregnancy within 18 months - You have a history of conditions like myasthenia gravis or Lambert-Eaton syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University Hospital Toulouse

Toulouse, France

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NCT03783572


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