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

NCT ID: NCT03453008

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-14
• Study Completion Date: 2019-09-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having notified his non-opposition to participate in the search
• Ischemic or hemorrhagic stroke of more than 6 months, cortical and / or subcortical;
• Indication to the realization of an injection of Botulinum Toxin A in the flexor muscles of the elbow according to the usual clinical criteria: presence of a functional complaint or aesthetic expressed by the patient and related to hyperactivity muscular (spasticity or cocontraction) on the flexor muscles elbow, which is a focal treatment by injection of botulinum toxin;
• Possibility of active extension of elbow> 20 °;
• Patients naive to Botulinum Toxin A or more than 4 months of a first injection of Botulinum Toxin A, having targeted the elbow flexors.

Exclusion Criteria

• Passive limitation of elbow extension> 30 °;
• Pain when performing active movements of flexion / extension of the elbow
• Cognitive impairment limiting the comprehension of three basic instructions (proof test of the 3 papers of the MMS);
• Evolutionary or decompensated neurological pathology; Ischemic or haemorrhagic stroke of less than 6 months;
• General contraindication to the production of botulinum toxin; history of myasthenia gravis, Lambert Eaton syndrome; history of neuromuscular disease; surgery with curarization for less than 1 month; treatment with aminoglycoside, aminoquinoline or cyclosporine
• Legal incapacity (safeguard of justice, guardianship).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Gasq, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Countries

France

Other Identifiers

2017-A01616-47

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0191

Identifier Type: -

Identifier Source: org_study_id