NCT03453008

Spastic Cocontractions and Limitation of Active Movements Before and After Treatment During Injection of Botulinum Toxin

Study of Spastic Cocontractions and Limitation of Active Movements of the Upper Limb Before and After Treatment During Injection of Botulinum Toxin in Patients After Stroke

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Following a stroke , 55% of the patients do not recover any traction of the upper limb and 30% a residual motricity not allowing a functional grip. For this last group of patients, there are major therapeutic issues to restore a functional grip. The aim of the study is to relieved the spastic cocontractions before and after usual injection of botulinum toxin A at stroke patient.

Detailed description

Descriptive study of spastic cocontraction index before and after botulinum toxin A injections during active elbow extension in chronic vascular hemiplegic patients. The spastic cocontraction score will be compared between T1 (before the Botulinum toxin A injection) and T2 (4 weeks after the botulinum toxin A injection in the elbow flexors). There is no control group. The patient is his own witness: the non-paretic side is considered as the physiological reference in terms of the level of spastic cocontractions. Botulinum toxin A injections are performed in routine clinical practice in the Physical Medicine and Rehabilitation Department, following the recommendations in force. This treatment has been shown to be effective on spasticity in several high-level studies. The reduction of spasticity, evaluated clinically (Tardieu and Ashworth scale), is a criterion of efficacy of botulinum toxin A injections. The evaluation of the effectiveness of botulinum toxin A injections on the other components of muscular hyperactivity, such as the reduction of spastic cocontraction during active movements, is poorly performed in clinical and clinical research. This protocol includes specific assessments to evaluate the evolution of spastic cocontraction.

Conditions

• Cerebrovascular Accident
• Stroke

Interventions

Type	Name	Description
OTHER	elbow extension, electromyography	Two evaluations before the toxin injection (T0 and T1), to quantify cocontractions and to determine the toxin injection pattern. The first evaluation (T0) will be carried out within a period of between 1 month and 15 days before the injection. This evaluation makes it possible to pose the indication for the realization of injection of Botulinum Toxin A (TBA). The second evaluation (T1) will be performed on the day of the injection to specify the muscle targets to be injected. The first evaluation is a Clinical evaluation and second is Instrumental evaluation

Timeline

• Start date: 2018-01-14
• Primary completion: 2019-08-01
• Completion: 2019-09-01
• First posted: 2018-03-02
• Last updated: 2018-03-05

Locations

1 site across 1 country: France