Effect of Repeated Injections of Higher Doses of Botulinum Toxin on Lower Limb of Spastic Hemiplegic Patients on Gait.

August 14, 2023 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

  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 MRI studies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. 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

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaire Saint Luc
      • Yvoir, Belgium, 5530
        • Cliniques Universitaires UCL Mont-Godinne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Drug: Xeomin Injectable Product
Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporo-spatial parameters of gait
Time Frame: 7-9 months
Improvement of temporo-spatial parameters of gait as assessed by quantified gait analysis
7-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Segmental kinematics of gait
Time Frame: 7-9 months
Improvement of segmental kinematics of gait as assessed by quantified gait analysis
7-9 months
Energetic parameters
Time Frame: 7-9 months
Improvement of energetic parameters of gait as assessed by quantified gait analysis
7-9 months
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.
7-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Gaëtan STOQUART, MD, PhD, Cliniques Universitaires Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-18 mai-217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Xeomin Injectable Product

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe