Upper-limb Active Function and Botulinum Toxin a

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
University Hospital Toulouse
RECRUITING
Toulouse
Contact Information
Primary
David Gasq, MD
gasq.d@chu-toulouse.fr
05 61 32 28 42
Backup
Audrey Tomasik
tomasik.a@chu-toulouse.fr
05 61 77 85 97
Time Frame
Start Date: 2020-12-08
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 80
Treatments
Experimental: Stroke patients
40 stroke patients : Injection of the TBA and the investigator will compare the measure of spastic cocontraction index (ICCS) during different movement before versus 4 weeks after injection of TBA : Clinical evaluation and Instrumental evaluation TBA injections are performed as part of routine care
Active_comparator: Control Group
The control group : Clinical evaluation consists in the search for criteria of non-inclusion and manual laterality score The will ha an Instrumental review just like the patient : concomitant evaluation of the 3D kinematics of the dominant upper limb, EMG of the triceps brachii muscles, biceps brachii, brachio-radial, brachial; associated with EEG recording, during active extension and elbow flexion movements, of the dominant upper extremity, at spontaneous and maximal speed Clinical evaluation
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov