Actively Recruiting

Age: 18Years +
All Genders
NCT07108920

Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait

Led by Hopital Nord Franche-Comte · Updated on 2025-09-22

15

Participants Needed

1

Research Sites

43 weeks

Total Duration

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AI-Summary

What this Trial Is About

Patients who suffered a stroke, cranial traumatism, medullar lesions or multiple sclerosis can present spastic muscular complications, which is particularly impairing if it concerns muscles of the leg. Muscular spastic complications of the legs can alter significantly the ability to walk because it clinically manifests itself by a stiffness of the leg, thus generating a complication called "Stif Knee Gait" (SKG). It means that the femoro-patello-tibial articulation cannot be mobilized as it should because it stays spastic instead of being mobile. However, it remains possible to treat this kind of medical condition by using Botulinum toxin injections in the target muscle, in particular the rectus femoris (which is part of the quadriceps). As a reminder, botulinum toxin, sold under the international common denomination "Botox®", is a neurotoxin of 150 kDa produced by the bacteria "Clostridium Botulinum" and is the most powerful natural poison known to humankind, with its DL50 between 1 and 2 nanogramms / kg in humans. This toxin works by entering the neuro-muscular synaptic junctions and by linking itself to a proteic complex called SNARE. The link between the toxin and the SNARE complex inhibits the fusion of the acetylcholinergic synaptic vesicles with the plasmic membrane of the pre-synaptic axone. The Botox® blocks the exocytosis of the acetycholin (Ach) vesicle in the inter-synaptic space at the neuro-muscular junction and blocks the nervous transmission, thus generating muscular flaccid paralysis. This kind of intoxication is caused directly by an infection by Clostridium Botulinum and is called Botulism. It manifests itself clinically by flaccid paralysis, swelling, diarrhea tiredness, respiratory failure, vomiting etc… Despite its highly toxic properties, Botox® can be used as a therapeutic tool against number of medical conditions (strabismus, hyperhidrosis, migraines etc…) and even as a cosmetic tool (anti face-wrinkles). It can be used against spastic muscular paralysis, especially like the ones encountered in the patients of this study. The current Standard Of Care (SOC) against SKG is to inject Botox into the rectus femoris in order to counter its spasticity. It has been shown to upgrade the walking ability of SKG patients by enhancing the leg kinetics. More precisely, it has been shown to improve the fluidity of the movement of the spastic leg in SKG patients, especially the knee flexion. However, the rectus femoris' contractility remains necessary to be able to stand up statically and to stay balanced during the walk and everyday-activity and the myorelaxant properties of Botox® may be problematic and alter the leg biomechanics despite its utility. To this day, no study has been published to compare the static and dynamic balance troubles before and after Botox injections in the rectus femoris. The medical bibliography does not report any augmentation of the risk of fall in the case of Botox injection in the rectus femoris. However, we consider the hypothesis along which those injections can enhance the risk of fall. Therefore, we decided to conduct a monocentric, prospective observational clinical study to compare the state of the static and dynamic balance before and after Botox injections in the rectus femoris (in SKG patients) by using balance scores. In order to complete this objective, we compared the following parameters before and after the Botox injection in SKG patients : * Time Up and Go test(in seconds) : primary evaluation criteria * Berg Balance Scale (BBS) : secondary evaluation criteria * Stair climb and descent time test (SCT) : secondary evaluation criteria. * Number of falls.

CONDITIONS

Official Title

Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with a stiff knee gait (SKG) after a stroke, a post-traumatic cerebral lesion or multiple sclerosis.
  • If the patient had a stroke, it happened at least 4 months ago (before the inclusion).
  • Rectus femoris spasticity of 1 or more on the modified Ashworth Scale with the hip in extension.
  • Quadriceps muscle strength of 2/5 or higher on the MRC Scale.
  • No botulinum toxin injections received during the previous 3 months.
  • No changes in anti-spastic medication during the month of inclusion (e.g., Baclofène, Dantrolène).
  • No neurosurgical intervention or ligamentoplasty of the quadriceps ligament during the previous 6 months.
  • No recent knee trauma with instability during the previous 6 weeks.
Not Eligible

You will not qualify if you...

  • Conditions that prevent performing functional tests, such as decompensated heart failure, unstable respiratory failure, coagulation disorders, or neurocognitive impairments.
  • Severe phasic disorders preventing the patient from completing evaluation scales.
  • Sensory impairments that prevent walking evaluation, including visual impairment, major proprioception deficits, or cerebellar ataxia.
  • Severe muscle deficits like genetic myopathy or psychomotor adaptation syndrome.
  • Absolute contraindications to botulinum toxin injections, including urinary tract infection, current treatment with aminoglycoside antibiotics, severe myasthenia, or inability to use a urinary catheter.
  • Cognitive difficulties affecting understanding or participation in the study.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre de Médecine Physique et de Réadaptation Bretegnier

Héricourt, Nord Franche-Comté, France, 70 400

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Research Team

J

Jean-Philippe JP Ehny, M.D

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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