StrokeULAFBoT-StrokeNCT03783572
Upper-limb Active Function and Botulinum Toxin A
A study testing Clinical evaluation and Clinical evaluation and Instrumental evaluation in people with Stroke and Muscle Spasticity, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Muscle Spasticity, Upper Extremity Paralysis
- What is being tested?
- Clinical evaluation and Clinical evaluation and Instrumental evaluation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2020to 29 Jun 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cortical and/or subcortical ischemic or haemorrhagic stroke for at least 6 months;
- Indication to an injection of BTA in the elbow flexor muscles according to the usual clinical criteria: request of elbow extension improvement with a functional or aesthetic objective;
- Being under prescription of abobotulinum toxin A (DYSPORT®, Ipsen-Pharma);
- Ability of active elbow extension> 20 degrees;
- Limitation of active movement of elbow extension > 15 degrees or decreased or 50% decrease in the active elbow extension rate;
- Patients who have never been treated with BTX or only a first injection that having targeted the elbow flexors more than 4 months ago;
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- Age> 18 years;
- Signature of informed consent;
- Subject affiliated to the social security coverture.
- Age> 18 years
- Signature of informed consent.
Who cannot join
- Passive limitation of elbow extension > 30 degrees;
- Pain during active movements of elbow flexion/extension;
- Cognitive disorder with limited comprehension of three basic instructions (like the test of the 3 papers of the MMS);
- Evolutionary or decompensated neurological disease;
- Unstabilized epilepsy;
- Anticoagulant treatment with a curative dose or hemostasis disorder that contraindicates intramuscular injections;
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- Claustrophobia or metallic foreign bodies contraindicated for MRI;
- General contraindication for botulinum toxin injection: hypersensitivity to the active substance or to one of the excipients, swallowing disorder, chronic respiratory disorders, antecedent of myasthenia or Lambert Eaton syndrome; antecedent of neuromuscular disease; surgery with curarization for less than a month; current treatment with aminoglycoside, aminoquinoline, cyclosporine or anticholinesterase.
- Presence of skin infection or inflammation at the injection site.
- Legal incapacity.
- Pregnant or breastfeeding woman;
- Woman with a desire to become pregnant within 18 months.
- Non-menopausal woman (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause) who does not use one of the following contraceptive methods considered highly effective : intrauterine device, oestroprogestonic contraception or progestogen hormonal contraception associated with inhibition of ovulation, intrauterine hormone-releasing system, or bilateral tubal occlusion.
- Control group
- History of orthopedic or neurologic disorders;
- Subject expert in a sport intensively requiring the upper limbs (at least departmental competition level);
- Legal incapacity.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed 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.
- Conditions
- Stroke, Muscle Spasticity, Upper Extremity Paralysis
- Being tested
- Clinical evaluation, Clinical evaluation and Instrumental evaluation
- Keywords
- Botulinum toxin, Cerebrovascular Accident, upper-limb movement, spastic cocontraction, electromyography, electroencephalography
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationOther
For the control group : only one clinical evaluation : search for non-inclusion criteria and manual laterality score
Clinical evaluation and Instrumental evaluationOther
For the patient : The standard clinical examination to evaluate movement : pain, motive power, spasticity plus Edinburgh's laterality score and Sensitivity deficiency by the Erasmus Nottingham Sensory Assessment (EmNSA) score and the evaluation of the cognitive function An encephalic MRI An instrumental evaluation : with concomitant recording of 3D kinematic data, surface and intramuscular EMG of the flexor and elbow extensor muscles, and EEG during active elbow extension, paretic and non-paretic movements.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Experimental | 40 stroke patients : Injection of the TBA and the investigator will compare the measure of spastic cocontraction index (ICCS) during different movement before versus 4 weeks after injection of TBA : Clinical evaluation and Instrumental evaluation TBA injections are performed as part of routine care Receives: Other: Clinical evaluation and Instrumental evaluation |
| Control Group | Active comparator | The control group : Clinical evaluation consists in the search for criteria of non-inclusion and manual laterality score The will ha an Instrumental review just like the patient : concomitant evaluation of the 3D kinematics of the dominant upper limb, EMG of the triceps brachii muscles, biceps brachii, brachio-radial, brachial; associated with EEG recording, during active extension and elbow flexion movements, of the dominant upper extremity, at spontaneous and maximal speed Clinical evaluation Receives: Other: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the spastic co-contraction index from the EMG signal
Measurement of the spastic co-contraction index (SCCI) during a maximal active elbow extension, obtained from the EMG signal of the elbow muscles on the paretic side before / after BTX injection.
Measured: 4 weeks
Secondary outcomes (7)
Spasticity of the elbow flexors
Spasticity of the elbow flexors according to Tardieu scale at different time : Spasticity is muscle resistance during fast-moving passive stretching. It is evaluated by the Tardieu scale and it consists in studying the evolution of the muscular reaction and its angle of occurrence.The muscular reaction to the rapid stretching of the muscle is graded in 5 classes from 0 to 4
Measured: 4 weeks
Limitation of the active movement angle 5LAMA) for elbow extension
Limitation of the active movement angle for elbow extension at different time : the subtractionof the angle of maximum elbow extension obtained during passive stretching of 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.
Measured: 4 weeks
The Fugl-Meyer Motor Function Assessment
Fugl-Meyer score at different visits : The Fugl-Meyer Motor Function Assessment, is a scale of evaluation of the reference voluntary motricity in the cerebral adult. The FMA-Motor portion of the upper limb is rated 66. It has high validity, reliability and sensitivity to change.
Measured: 4 weeks
Functional capabilities with Wolf Motor Function Test score at different visits
Functional capabilities with WMFT score : standardized scale assessing upper limb capacities in cerebral palsy adults The scale consists of 17 standardized tests, sorted in order of increasing complexity, which solicit the proximal joints through analytical movements, and progress towards the distal joints through the execution of functional tasks of grasping, grasping and manipulating objects, evaluating single- and bimanual grips. The handover device is standardized. WMFT assesses three aspects of movement
Measured: 4 weeks
EEG quantification of bilateral cortical activity during movement
EEG quantification of bilateral cortical activity during movement to calculate the Desynchronization index (ERD) identifying hyperactivity in the ipsilesional cortex
Measured: 4 weeks
Cortico-spinal excitability of the motor cortex
Cortico-spinal excitability of the motor cortex assessed with TMS : TMS is a non-invasive magnetic stimulation technique that evaluates the integrity of the corticospinal tract. One of the measures used in current practice is that of the amplitude variations of a EMF collected by EMG of the surface elbow flexors as a function of stimulation intensity. The intensity curve is an index of cortical excitability.
Measured: 4 weeks
Integrity of encephalic motor tracts
Integrity of encephalic motor tracts with an anatomic and diffusion RMI : An encephalic MRI without injection of contrast material with an anatomical sequence and a diffusion sequence will make it possible to evaluate the integrity of the motor pathways at the cortical level, the internal capsule, and the brainstem.
The interest will be to evaluate the level of integrity of the cortico-spinal tract compared to other bundles, with the hypothesis that a lesion of the cortico-spinal tract favors the in play of the accessory motorways
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start8 Dec 2020
- Primary completion29 Jun 2024
- Study completion29 Jun 2024
Why it stopped: Difficulties in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups, one with 40 stroke patients and the control group with 40 healthy subjects prospective, longitudinal, without blinding, multicenter.
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT03783572
- Sponsor's protocol ID
- RC31/17/0455
- Other IDs
- 2018-000941-38, 2018
- Acronym
- ULAFBoT-Stroke
- Status last verified
- May 2026
- First submitted
- 18 Dec 2018
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper-limb Active Function and Botulinum Toxin A
- ClinicalTrials.gov ID
- NCT03783572
- Acronym / sponsor ID
- ULAFBoT-Stroke / RC31/17/0455
- Conditions
- Stroke, Muscle Spasticity, Upper Extremity Paralysis
- Keywords
- Botulinum toxin, Cerebrovascular Accident, upper-limb movement, spastic cocontraction, electromyography, electroencephalography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting patients
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 21 Dec 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.
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
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups, one with 40 stroke patients and the control group with 40 healthy subjects prospective, longitudinal, without blinding, multicenter.
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | Experimental | Other: Clinical evaluation and Instrumental evaluation40 stroke patients : Injection of the TBA and the investigator will compare the measure of spastic cocontraction index (ICCS) during different movement before versus 4 weeks after injection of TBA : Clinical evaluation and Instrumental evaluation TBA injections are performed as part of routine care |
| Control Group | Active comparator | Other: Clinical evaluationThe control group : Clinical evaluation consists in the search for criteria of non-inclusion and manual laterality score The will ha an Instrumental review just like the patient : concomitant evaluation of the 3D kinematics of the dominant upper limb, EMG of the triceps brachii muscles, biceps brachii, brachio-radial, brachial; associated with EEG recording, during active extension and elbow flexion movements, of the dominant upper extremity, at spontaneous and maximal speed Clinical evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Cortical and/or subcortical ischemic or haemorrhagic stroke for at least 6 months;
- Indication to an injection of BTA in the elbow flexor muscles according to the usual clinical criteria: request of elbow extension improvement with a functional or aesthetic objective;
- Being under prescription of abobotulinum toxin A (DYSPORT®, Ipsen-Pharma);
- Ability of active elbow extension> 20 degrees;
- Limitation of active movement of elbow extension > 15 degrees or decreased or 50% decrease in the active elbow extension rate;
Key exclusion criteria (17 listed)
- Passive limitation of elbow extension > 30 degrees;
- Pain during active movements of elbow flexion/extension;
- Cognitive disorder with limited comprehension of three basic instructions (like the test of the 3 papers of the MMS);
- Evolutionary or decompensated neurological disease;
- Unstabilized epilepsy;
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 |
|---|---|---|
| Clinical evaluationFor the control group : only one clinical evaluation : search for non-inclusion criteria and manual laterality score | Other | Control Group |
| Clinical evaluation and Instrumental evaluationFor the patient : The standard clinical examination to evaluate movement : pain, motive power, spasticity plus Edinburgh's laterality score and Sensitivity deficiency by the Erasmus Nottingham Sensory Assessment (EmNSA) score and the evaluation of the cognitive function An encephalic MRI An instrumental evaluation : with concomitant recording of 3D kinematic data, surface and intramuscular EMG of the flexor and elbow extensor muscles, and EEG during active elbow extension, paretic and non-paretic movements. | Other | Stroke patients |
Primary outcome
Measurement of the spastic co-contraction index from the EMG signal
Time frame: 4 weeks
Measurement of the spastic co-contraction index (SCCI) during a maximal active elbow extension, obtained from the EMG signal of the elbow muscles on the paretic side before / after BTX injection.
7 secondary outcomes
Spasticity of the elbow flexors
Time frame: 4 weeks
Limitation of the active movement angle 5LAMA) for elbow extension
Time frame: 4 weeks
The Fugl-Meyer Motor Function Assessment
Time frame: 4 weeks
Functional capabilities with Wolf Motor Function Test score at different visits
Time frame: 4 weeks
EEG quantification of bilateral cortical activity during movement
Time frame: 4 weeks
Cortico-spinal excitability of the motor cortex
Time frame: 4 weeks
Integrity of encephalic motor tracts
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Clinical evaluation and Clinical evaluation and Instrumental evaluation in people with Stroke and Muscle Spasticity, 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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 1 Jun 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 was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
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 the spastic co-contraction index from the EMG signal (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.