Upper-limb Active Function and Botulinum Toxin A — ULAFBoT-Stroke  

Stroke Clinical Trial

Official title: Upper-limb Active Function and Botulinum Toxin A

Status Recruiting

Clinical Trial 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

Clinical Trial Description

BTX is a valuable treatment in the management of the focal muscle overactivity (spasticity) following acquired brain injury. If BTX injections reduce spasticity, few studies have examined its effect on the improvement of active function of the upper limb.

Motor task involves the muscles agonists and antagonists by phenomena of muscular coactivation.

In post-stroke patients, functional cortical reorganization secondary to the phenomena of plasticity leads to a reduced motor selectivity. The increase of muscular coactivation correspond to the spastic cocontraction, which are a little evaluated in clinical practice and research, whereas they appear to have a greater impact than spasticity on limitation of active movement.

This study does not evaluate the efficacy of treatment (BTX injection) but the effect of this treatment on a component of muscle hyperactivity, the spastic cocontraction.

In addition to the 5 follow-up visits, patients have 6 intercurrent visits. These visits are less invasive and include only a clinical assessment with surface EMG registration. These evaluations will evaluate the efficacy and harm effect of BTX on clinical parameters and on the spastic co-contraction index. Five intercurrent visits I1, I2, I3, I4, I5 are perform respectively 2 weeks after T1 and, 3, 6, 9, 12 weeks after T2. ;

Related Conditions & MeSH terms

• Muscle Spasticity
• Paralysis
• Stroke
• Upper Extremity Paralysis

• NCT number: NCT03783572
• Study type: Interventional
• Source: University Hospital, Toulouse
• Contact: David Gasq, MD
• Phone: 05 61 32 28 42
• Email: gasq.d@chu-toulouse.fr
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2020
• Completion date: December 30, 2027