Status:

RECRUITING

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

Lead Sponsor:

Hopital Nord Franche-Comte

Conditions:

Botulinum Toxin Injection

Stiff Knee Gait

Eligibility:

All Genders

18+ years

Brief Summary

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...

Eligibility Criteria

Inclusion Criteria:

  • Patient with a stif knee gait (SKG) after a stroke, a post-traumatic cerebral lesion or a multiple sclerosis.
  • If the patient had a stroke, it happened at least 4 month ago (before the inclusion).
  • The patient has a rectus femoris spasticity ≥ 1 on the modified Ashworth Scale with the hip in extension position.
  • A quadricipital muscular force ≥ 2/5 (MRC Scale)
  • The patient didn't receive any botulinum toxin injection during the 3 previous months
  • No modification of any anti-spastic medication during the inclusion in the actual month (Baclofène, Dantrolène).
  • No neurosurgical intervention or ligamentoplasty of the quadricipital ligament during the 6 previous months.
  • No recent knee traumatism with knee instability during the 6 previous weeks.

Exclusion Criteria:

  • Other comorbidities invalidating the fonctionnal tests necessary for the study like : decompensated cardiac insufficiency, unstable respiratory insufficiency, coagulation troubles, neurocognitive impairments inhibiting the comprehension of isocinetical tests.
  • Patient without severe phasic trouble inhibiting the patient's ability to answer the evaluation scales.
  • Sensory lesions inhibiting the possibility to evaluate the walk : visual impairment, major proprioception impairment, or cerebellar ataxia.
  • Severe muscular deficit : genetic myopathy, psychomotric desadaptation syndrom
  • Absolute contraindication to botulinum toxin injections : urinary tract infection ; current treatment by aminoglycosidic antibiotics, severe myasthenia, urine retention in patient who can't receive a urinary catheter.
  • Patient with cognitive troubles compromitting the understanding and the realization of the study.

Key Trial Info

Start Date :

October 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT07108920

Start Date

October 1 2025

End Date

August 1 2026

Last Update

September 22 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Centre de Médecine Physique et de Réadaptation Bretegnier

Héricourt, Nord Franche-Comté, France, 70 400

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