StrokeNCT04544280
Effect of Repeated Injections of Higher Doses of Botulinum Toxin on Lower Limb of Spastic Hemiplegic Patients on Gait.
A study testing Xeomin Injectable Product in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial summary
1. To show that repeated injections of higher doses of botulinum toxin are significantly more effective than the injection of unique, lower doses, on gait function. 2. To describe the effect of repeated injections of botulinum toxin on the muscle structure in terms of volume, fat accumulation and fibrosis, by means of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Xeomin Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesBelgium
- Study dates
- 13 Sep 2018to 31 Dec 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemiparesis secondary to stroke, date of stroke>3 months ago, lower limb hyper resistance responsible of gait impairment, focal chemical denervation indication, ability to walk on a treadmill
Who cannot join
- aphasia or major cognitive impairments limiting the functional evaluation, neurological or orthopedic affections interfering with the studied lower limb's function, botulinum toxin injections on the lower limb during the last 3 months, contraindication to botulinum toxin injections (underlying neuromuscular disease) and no contraindication to undergo an MRI study.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques Universitaire Saint Luc
Brussels, 1200
Cliniques Universitaires UCL Mont-Godinne
Yvoir, 5530
About this study
Official title: Évaluation de l'Effet d'Injections répétées de Hautes Doses de Toxine Botulique Dans le Membre inférieur de Sujets cérébrolésés Spastiques Sur Les paramètres Fonctionnels et biomécaniques de Marche
- To show that repeated injections of higher doses of botulinum toxin are significantly more effective than the injection of unique, lower doses, on gait function.
- To describe the effect of repeated injections of botulinum toxin on the muscle structure in terms of volume, fat accumulation and fibrosis, by means of MRI studies
Read the detailed description
- A prospective, interventional, multi-centre, open-labeled study will be carried out. Sixty stroke patients will be recruited (from the Rehabilitation Ward of Cliniques Universitaires Saint-Luc (UCLouvain), or Centre Hospitalier Universitaire de Mont Godinne (UCLouvain), or in the out-patients clinic), if they have an indication for focal chemical denervation (by botulinum toxin injections) to treat lower limb hyper-resistance (spasticity). Inclusion criteria: adults (>18 years old), hemiparesis secondary to stroke, date of stroke>3 months ago, lower limb hyper-resistance responsible of gait impairment, focal chemical denervation indication, ability to walk on a treadmill. Exclusion criteria: aphasia or major cognitive impairments limiting the functional evaluation, neurological or orthopedic affections interfering with the studied lower limb's function, BONT injections on the lower limb during the last 3 months, contraindication to BONT injections (underlying neuromuscular disease) and no contraindication to undergo an MRI study. Patients will benefit from 3 sessions of botulinum toxin (Xeomeen) injections at 3 months intervals. During the first session, 400 U of Xeomeen will be injected in the lower limb of the patient (and upper limb, if needed). During the second session, 600U of Xeomeen will be injected and during the third session, 800Units of Xeomeen will be injected (in the lower limb of the patient-and upper limb, if needed-). The injections will be based on the clinical evaluation carried out by one of the investigators, who are medical doctors, specialized in Physical and Rehabilitation Medicine and have experience with hyper-resistance treatment with botulinum toxin. Patients will be evaluated just before, a month later and 3 months after each injection session. Functional evaluations are based on the ICF model. Impairment will be evaluated by the clinical examination (range of motion -ROM- with a hand goniometer, MAS and Tardieu scale for spasticity, Fugl-Meyer test for motor control)20; by functional evaluations (10 meters walk test, 6 minutes walk test, timed up and down the stairs test, Timed Up and Go Test) and by a 3D-Quantified Gait Analysis. The limitations in activities of daily life will be evaluated by means of the ABILOCO questionnaire. Quality of life (QoL) will be evaluated with the French version of the Short-Form Health Survey SF-3624.
- To describe the effect of repeated injections of botulinum toxin (Xeomeen) on the muscle structure in terms of volume, fat accumulation and fibrosis, a lower limb MRI will be performed before, 1-3 days and 1 month after the 1st Xeomeen injection, and 1 month after the 3rd BONT injection, for 4 MRI studies per patient. Twenty hemiplegic subjects will be recruited. They will participate to the complete study protocol, as described for our first objective. Inclusion and exclusion criteria will be the same as previously described.
Statistical analysis: The effects of treatment on continuous variables will be assessed by a one-way (time) repeated-measures analysis of variance (Anova). Ordinal data will be assessed by a non-parametric analysis. A Chi2 test will be used to compare the distributions of qualitative variables. Testing will be performed with a p-value <0,05.
- Conditions
- Stroke
- Being tested
- Xeomin Injectable Product
- Keywords
- stroke, botulinum neurotoxin, spasticity, hyper-resistance, MRI, muscle structure, gait rehabilitation
- 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.
Xeomin Injectable ProductDrug
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Drug: Xeomin Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporo-spatial parameters of gait
Improvement of temporo-spatial parameters of gait as assessed by quantified gait analysis
Measured: 7-9 months
Secondary outcomes (3)
Segmental kinematics of gait
Improvement of segmental kinematics of gait as assessed by quantified gait analysis
Measured: 7-9 months
Energetic parameters
Improvement of energetic parameters of gait as assessed by quantified gait analysis
Measured: 7-9 months
Muscle structure
Modification of muscle structure (volume, presence of fatty and fibrotic tissue) after repeated botulinum toxin injections as evaluated by MRI imaging.
Measured: 7-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start13 Sep 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, interventional, multi-centre, open-labeled study.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan STOQUART, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544280
- Sponsor's protocol ID
- 2018-18 mai-217
- Status last verified
- Aug 2023
- First submitted
- 3 Sep 2020
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corriveau H, Hebert R, Raiche M, Dubois MF, Prince F. Postural stability in the elderly: empirical confirmation of a theoretical model. Arch Gerontol Geriatr. 2004 Sep-Oct;39(2):163-77. doi: 10.1016/j.archger.2004.03.001.
PubMed 15249153Hirvensalo M, Rantanen T, Heikkinen E. Mobility difficulties and physical activity as predictors of mortality and loss of independence in the community-living older population. J Am Geriatr Soc. 2000 May;48(5):493-8. doi: 10.1111/j.1532-5415.2000.tb04994.x.
PubMed 10811541Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.
PubMed 6661021Pinzur MS, Sherman R, DiMonte-Levine P, Trimble J. Gait changes in adult onset hemiplegia. Am J Phys Med. 1987 Oct;66(5):228-37.
PubMed 3324770Olney SJ, Griffin MP, McBride ID. Temporal, kinematic, and kinetic variables related to gait speed in subjects with hemiplegia: a regression approach. Phys Ther. 1994 Sep;74(9):872-85. doi: 10.1093/ptj/74.9.872.
PubMed 8066114Stoquart G, Detrembleur C, Lejeune TM. The reasons why stroke patients expend so much energy to walk slowly. Gait Posture. 2012 Jul;36(3):409-13. doi: 10.1016/j.gaitpost.2012.03.019. Epub 2012 May 1.
PubMed 22555062Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
PubMed 18635841Wissel J, Bensmail D, Ferreira JJ, Molteni F, Satkunam L, Moraleda S, Rekand T, McGuire J, Scheschonka A, Flatau-Baque B, Simon O, Rochford ET, Dressler D, Simpson DM; TOWER study investigators. Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study. Neurology. 2017 Apr 4;88(14):1321-1328. doi: 10.1212/WNL.0000000000003789. Epub 2017 Mar 10.
PubMed 28283596Minamoto VB, Suzuki KP, Bremner SN, Lieber RL, Ward SR. Dramatic changes in muscle contractile and structural properties after 2 botulinum toxin injections. Muscle Nerve. 2015 Oct;52(4):649-57. doi: 10.1002/mus.24576. Epub 2015 Jun 30.
PubMed 25598004Selves C, Dehem S, Lejeune T, Deltombe T, Stoquart G. Effects of 3 Cycles of Increasing Botulinum Toxin Doses on Functional Parameters of Post-stroke Spastic Gait: A Prospective Cohort Study. NeuroRehabilitation. 2025 Mar;56(2):175-185. doi: 10.1177/10538135241303343. Epub 2024 Dec 24.
PubMed 40135684
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation de l'Effet d'Injections répétées de Hautes Doses de Toxine Botulique Dans le Membre inférieur de Sujets cérébrolésés Spastiques Sur Les paramètres Fonctionnels et biomécaniques de Marche
- ClinicalTrials.gov ID
- NCT04544280
- Acronym / sponsor ID
- 2018-18 mai-217
- Conditions
- Stroke
- Keywords
- stroke, botulinum neurotoxin, spasticity, hyper-resistance, MRI, muscle structure, gait rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Sep 2020 (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.
- To show that repeated injections of higher doses of botulinum toxin are significantly more effective than the injection of unique, lower doses, on gait function.
- To describe the effect of repeated injections of botulinum toxin on the muscle structure in terms of volume, fat accumulation and fibrosis, by means of MRI studies
Detailed description
- A prospective, interventional, multi-centre, open-labeled study will be carried out. Sixty stroke patients will be recruited (from the Rehabilitation Ward of Cliniques Universitaires Saint-Luc (UCLouvain), or Centre Hospitalier Universitaire de Mont Godinne (UCLouvain), or in the out-patients clinic), if they have an indication for focal chemical denervation (by botulinum toxin injections) to treat lower limb hyper-resistance (spasticity). Inclusion criteria: adults (>18 years old), hemiparesis secondary to stroke, date of stroke>3 months ago, lower limb hyper-resistance responsible of gait impairment, focal chemical denervation indication, ability to walk on a treadmill. Exclusion criteria: aphasia or major cognitive impairments limiting the functional evaluation, neurological or orthopedic affections interfering with the studied lower limb's function, BONT injections on the lower limb during the last 3 months, contraindication to BONT injections (underlying neuromuscular disease) and no contraindication to undergo an MRI study. Patients will benefit from 3 sessions of botulinum toxin (Xeomeen) injections at 3 months intervals. During the first session, 400 U of Xeomeen will be injected in the lower limb of the patient (and upper limb, if needed). During the second session, 600U of Xeomeen will be injected and during the third session, 800Units of Xeomeen will be injected (in the lower limb of the patient-and upper limb, if needed-). The injections will be based on the clinical evaluation carried out by one of the investigators, who are medical doctors, specialized in Physical and Rehabilitation Medicine and have experience with hyper-resistance treatment with botulinum toxin. Patients will be evaluated just before, a month later and 3 months after each injection session. Functional evaluations are based on the ICF model. Impairment will be evaluated by the clinical examination (range of motion -ROM- with a hand goniometer, MAS and Tardieu scale for spasticity, Fugl-Meyer test for motor control)20; by functional evaluations (10 meters walk test, 6 minutes walk test, timed up and down the stairs test, Timed Up and Go Test) and by a 3D-Quantified Gait Analysis. The limitations in activities of daily life will be evaluated by means of the ABILOCO questionnaire. Quality of life (QoL) will be evaluated with the French version of the Short-Form Health Survey SF-3624.
- To describe the effect of repeated injections of botulinum toxin (Xeomeen) on the muscle structure in terms of volume, fat accumulation and fibrosis, a lower limb MRI will be performed before, 1-3 days and 1 month after the 1st Xeomeen injection, and 1 month after the 3rd BONT injection, for 4 MRI studies per patient. Twenty hemiplegic subjects will be recruited. They will participate to the complete study protocol, as described for our first objective. Inclusion and exclusion criteria will be the same as previously described.
Statistical analysis: The effects of treatment on continuous variables will be assessed by a one-way (time) repeated-measures analysis of variance (Anova). Ordinal data will be assessed by a non-parametric analysis. A Chi2 test will be used to compare the distributions of qualitative variables. Testing will be performed with a p-value <0,05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, interventional, multi-centre, open-labeled study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Xeomin Injectable Product |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemiparesis secondary to stroke, date of stroke>3 months ago, lower limb hyper resistance responsible of gait impairment, focal chemical denervation indication, ability to walk on a treadmill
Key exclusion criteria (1 listed)
- aphasia or major cognitive impairments limiting the functional evaluation, neurological or orthopedic affections interfering with the studied lower limb's function, botulinum toxin injections on the lower limb during the last 3 months, contraindication to botulinum toxin injections (underlying neuromuscular disease) and no contraindication to undergo an MRI study.
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 |
|---|---|---|
| Xeomin Injectable ProductIntramuscular injection | Drug | Intervention |
Primary outcome
Temporo-spatial parameters of gait
Time frame: 7-9 months
Improvement of temporo-spatial parameters of gait as assessed by quantified gait analysis
3 secondary outcomes
Segmental kinematics of gait
Time frame: 7-9 months
Energetic parameters
Time frame: 7-9 months
Muscle structure
Time frame: 7-9 months
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 15 Aug 2023.
- Background: PubMed 15249153Corriveau H, Hebert R, Raiche M, Dubois MF, Prince F. Postural stability in the elderly: empirical confirmation of a theoretical model. Arch Gerontol Geriatr. 2004 Sep-Oct;39(2):163-77. doi: 10.1016/j.archger.2004.03.001.
- Background: PubMed 10811541Hirvensalo M, Rantanen T, Heikkinen E. Mobility difficulties and physical activity as predictors of mortality and loss of independence in the community-living older population. J Am Geriatr Soc. 2000 May;48(5):493-8. doi: 10.1111/j.1532-5415.2000.tb04994.x.
- Background: PubMed 6661021Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.
- Background: PubMed 3324770Pinzur MS, Sherman R, DiMonte-Levine P, Trimble J. Gait changes in adult onset hemiplegia. Am J Phys Med. 1987 Oct;66(5):228-37.
- Background: PubMed 8066114Olney SJ, Griffin MP, McBride ID. Temporal, kinematic, and kinetic variables related to gait speed in subjects with hemiplegia: a regression approach. Phys Ther. 1994 Sep;74(9):872-85. doi: 10.1093/ptj/74.9.872.
- Background: PubMed 22555062Stoquart G, Detrembleur C, Lejeune TM. The reasons why stroke patients expend so much energy to walk slowly. Gait Posture. 2012 Jul;36(3):409-13. doi: 10.1016/j.gaitpost.2012.03.019. Epub 2012 May 1.
- Background: PubMed 18635841Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
- Background: PubMed 28283596Wissel J, Bensmail D, Ferreira JJ, Molteni F, Satkunam L, Moraleda S, Rekand T, McGuire J, Scheschonka A, Flatau-Baque B, Simon O, Rochford ET, Dressler D, Simpson DM; TOWER study investigators. Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study. Neurology. 2017 Apr 4;88(14):1321-1328. doi: 10.1212/WNL.0000000000003789. Epub 2017 Mar 10.
- Background: PubMed 25598004Minamoto VB, Suzuki KP, Bremner SN, Lieber RL, Ward SR. Dramatic changes in muscle contractile and structural properties after 2 botulinum toxin injections. Muscle Nerve. 2015 Oct;52(4):649-57. doi: 10.1002/mus.24576. Epub 2015 Jun 30.
- Derived from this study: PubMed 40135684Selves C, Dehem S, Lejeune T, Deltombe T, Stoquart G. Effects of 3 Cycles of Increasing Botulinum Toxin Doses on Functional Parameters of Post-stroke Spastic Gait: A Prospective Cohort Study. NeuroRehabilitation. 2025 Mar;56(2):175-185. doi: 10.1177/10538135241303343. Epub 2024 Dec 24.
- 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.
Gaëtan STOQUART, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xeomin Injectable Product in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
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 1 inclusion and 1 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 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Temporo-spatial parameters of gait (time frame: 7-9 months). 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 NCT04544280, which also lists 10 linked publications.
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 15 Aug 2023.