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

NCT03453008 | Completed

• 2 other identifiers: RC31/17/01912017-A01616-47
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident; Stroke

Keywords

Cerebrovascular Accident; Botulinum toxin A; Stroke

Outcome Measures

Primary Outcomes (1)

• Measurement of spastic cocontraction index during active elbow extension

  Measurement of spastic cocontraction index during active elbow extension, obtained from the electromyography signal of the extensor and flexor muscles of the elbow paretic side, between T1 and T2 (before / after the injection of Botulinum Toxin A).

  2 hours

Secondary Outcomes (6)

• Sensory balance of the upper limb

  2 hours

• Evaluation of the voluntary muscular force

  2 hours

• Evaluation of spasticity

  2 hours

• Limitation of Active Motion Angle Elbow Extension

  2 hours

• Fugl-Meyer score (motor selectivity)

  2 hours

Interventions

elbow extension, electromyography OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Ischemic or hemorrhagic stroke of more than 6 months, cortical and / or subcortical and an who can have a Botulinum Toxin A injection.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31052, France

Location

Related Publications (1)

• Delcamp C, Cormier C, Chalard A, Amarantini D, Gasq D. Botulinum toxin combined with rehabilitation decrease corticomuscular coherence in stroke patients. Clin Neurophysiol. 2022 Apr;136:49-57. doi: 10.1016/j.clinph.2021.12.019. Epub 2022 Jan 21.

  PMID: 35131638 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Gasq, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: January 14, 2018
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)