Cerebrovascular AccidentNCT03453008
Spastic Cocontractions and Limitation of Active Movements Before and After Treatment During Injection of Botulinum Toxin
An observational study of Cerebrovascular Accident and Stroke, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Stroke
- What is being tested?
- elbow extension, electromyography
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2018to 21 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- elbow extension, electromyography
- Keywords
- Cerebrovascular Accident, Botulinum toxin A, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elbow extension, electromyographyOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours
Secondary outcomes (6)
Sensory balance of the upper limb
The Erasmus Modified Nottingham Assessment (EmNSA), validated in English, allows a comprehensive evaluation of the superficial epicritic, proprioceptive sensitivity and stereognosis of the entire upper limb in the hemiplegic patient.
Measured: 2 hours
Evaluation of the voluntary muscular force
Held and Pierrot-Deseilligny scale, which abstracts from the notions of gravity and range of motion.
Measured: 2 hours
Evaluation of spasticity
It is evaluated by the Tardieu scale. The analysis will consist of studying the evolution of the muscular reaction and its angle of onset (Tardieu scale) during each of the clinical evaluations.
Measured: 2 hours
Limitation of Active Motion Angle Elbow Extension
Limitation of Active Motion Angle (LAMA) is the clinical measure of the consequences of a spastic cocontraction in a patient. To calculate it, we subtract the maximum elbow extension angle obtained during the PASSIVE stretch of the muscles at the maximum elbow extension angle obtained during a voluntary ACTIVE contraction. As part of the protocol, the LAMA will be instrumentally measured with the 3D kinematic system (Optitrack).
This data is expressed in gross value (in degrees) or in percentage (depending on the maximum amplitude obtained during passive stretching).
Measured: 2 hours
Fugl-Meyer score (motor selectivity)
The Fugl-Meyer Motor Function Assessment (FMA-Motor), based on the motor recovery scheme described by Brunnstrom (1975), is a scale of evaluation of voluntary reference motor function in the cerebral adult, often used in research and development in clinical practice. The FMA-Motor part of the upper limb is rated 66. It has high validity, reliability and sensitivity to change.
Measured: 2 hours
Functional abilities with the Wolf Motor Function Test score
Functional abilities with the Wolf Motor Function Test validated in more than 16 languages (including French) since 2013, is a standardized scale evaluating upper limb capacities in cerebral palsy adults. Originally designed by Steven Wolf (1987) to quantify the effects of stress-induced therapy, this tool is often used in research protocols in the acute and chronic phase brain. The scale consists of performing 17 standardized tests, classified in order of increasing complexity, which solicit the proximal joints
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start14 Jan 2018
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Gasq, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453008
- Sponsor's protocol ID
- RC31/17/0191
- Other IDs
- 2017-A01616-47
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2018
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35131638
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03453008
- Acronym / sponsor ID
- RC31/17/0191
- Conditions
- Cerebrovascular Accident, Stroke
- Keywords
- Cerebrovascular Accident, Botulinum toxin A, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elbow extension, electromyographyTwo 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 | Other | – |
Primary outcome
Measurement of spastic cocontraction index during active elbow extension
Time frame: 2 hours
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).
6 secondary outcomes
Sensory balance of the upper limb
Time frame: 2 hours
Evaluation of the voluntary muscular force
Time frame: 2 hours
Evaluation of spasticity
Time frame: 2 hours
Limitation of Active Motion Angle Elbow Extension
Time frame: 2 hours
Fugl-Meyer score (motor selectivity)
Time frame: 2 hours
Functional abilities with the Wolf Motor Function Test score
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Results publication: PubMed 35131638Delcamp 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.
- Individual participant dataSharing planned: No
Related trials for Cerebrovascular Accident
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gasq, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Stroke, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of spastic cocontraction index during active elbow extension (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.