Effect of Repeated Injections of Higher Doses of Botulinum Toxin on Lower Limb of Spastic Hemiplegic Patients on Gait.
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| ClinicalTrials.gov Identifier: NCT04544280 |
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Recruitment Status :
Recruiting
First Posted : September 10, 2020
Last Update Posted : February 4, 2022
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- 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Drug: Xeomin Injectable Product | Not Applicable |
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | prospective, interventional, multi-centre, open-labeled study. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 13, 2018 |
| Estimated Primary Completion Date : | September 12, 2023 |
| Estimated Study Completion Date : | September 12, 2023 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Intervention |
Drug: Xeomin Injectable Product
Intramuscular injection |
- Temporo-spatial parameters of gait [ Time Frame: 7-9 months ]Improvement of temporo-spatial parameters of gait as assessed by quantified gait analysis
- Segmental kinematics of gait [ Time Frame: 7-9 months ]Improvement of segmental kinematics of gait as assessed by quantified gait analysis
- Energetic parameters [ Time Frame: 7-9 months ]Improvement of energetic parameters of gait as assessed by quantified gait analysis
- Muscle structure [ Time Frame: 7-9 months ]Modification of muscle structure (volume, presence of fatty and fibrotic tissue) after repeated botulinum toxin injections as evaluated by MRI imaging.
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544280
| Contact: Clara SELVES, MD | +327648646 | clara.selves@uclouvain.be | |
| Contact: Gaëtan STOQUART, MD, PhD | +327641649 | gaetan.stoquart@uclouvain.be |
| Belgium | |
| Cliniques Universitaire Saint Luc | Recruiting |
| Bruxelles, Belgium, 1200 | |
| Contact: Clara SELVES, MD +327648646 clara.selves@uclouvain.be | |
| Contact clara.selves@uclouvain.be | |
| Sub-Investigator: Clara SELVES, MD | |
| Principal Investigator: Gaëtan STOQUART, MD, PhD | |
| Cliniques Universitaires UCL Mont-Godinne | Recruiting |
| Yvoir, Belgium, 5530 | |
| Contact: Thierry DELTOMBE, MD, PhD therry.deltombe@uclouvain.be | |
| Responsible Party: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT04544280 |
| Other Study ID Numbers: |
2018-18 mai-217 |
| First Posted: | September 10, 2020 Key Record Dates |
| Last Update Posted: | February 4, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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stroke botulinum neurotoxin spasticity hyper-resistance |
MRI muscle structure gait rehabilitation |
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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases incobotulinumtoxinA |
Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |