Actively Recruiting
Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait: What About the Risk of Falls?
Led by Hopital Nord Franche-Comte · Updated on 2025-09-22
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients experiencing stiff knee gait (SKG), a condition caused by spastic muscle complications in the leg that can result from stroke, brain injury, spinal cord damage, or multiple sclerosis. SKG affects the mobility of the knee joint, leading to stiffness that hampers walking ability. The study aims to observe and compare balance and risk of falls before and after treatment with botulinum toxin injections in the rectus femoris muscle, which is a current standard treatment to reduce muscle spasticity in these patients. Participants will receive botulinum toxin injections targeted to the rectus femoris muscle. The study is observational and will evaluate the effects of these injections on balance and walking ability without altering standard care. Functional clinical tests such as the Time Up and Go test, Berg Balance Scale, Stair Climb and Descent Time test, and a questionnaire about the number of falls will be used to assess participants before and four weeks after the injections. Throughout the study, participants will undergo these clinical tests to measure static and dynamic balance and walking function. Researchers will specifically focus on the Time Up and Go test as the primary outcome four weeks after treatment. Secondary outcomes include balance scale scores, stair climbing times, and fall frequency. The study will also monitor safety and compliance. The total study duration for each participant is at least four weeks from the inclusion visit to the post-injection evaluation.
CONDITIONS
Brief Title
Analysis of Balance Disorders After Botulinum Toxin Treatment in the Rectus Femoris in Patients With a Stiff Knee Gait
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a stiff knee gait (SKG) after stroke, post-traumatic brain injury, or multiple sclerosis.
- Stroke must have occurred at least 4 months before inclusion.
- Rectus femoris spasticity score of 1 or higher on the modified Ashworth Scale with hip in extension.
- Quadriceps muscle strength of 2/5 or higher on the MRC Scale.
- No botulinum toxin injections in the previous 3 months.
- No changes to anti-spastic medication (e.g., Baclofène, Dantrolène) in the current month.
- No neurosurgical intervention or quadricipital ligament ligamentoplasty in the past 6 months.
- No recent knee injury with instability in the past 6 weeks.
You will not qualify if you...
- Other health conditions preventing functional tests, such as unstable heart or lung failure, coagulation problems, or cognitive impairments affecting test comprehension.
- Severe phasic disorders that prevent answering evaluation scales.
- Sensory impairments affecting walking assessment, including visual impairment, major proprioception loss, or cerebellar ataxia.
- Severe muscle deficits like genetic myopathy or psychomotor dysfunction.
- Absolute contraindications to botulinum toxin injections, including urinary tract infection, use of aminoglycosidic antibiotics, severe myasthenia, or inability to receive urinary catheter.
- Cognitive difficulties that impair understanding or participation in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks after the Botulinum toxin injection visit
Participants undergo functional clinical tests including the Time Up and Go test, Berg Balance Scale, Stair climb and descent time test, and complete a falls questionnaire to assess balance disorders after treatment.
1 visit (in-person) 4 weeks after injection
Trial Site Locations
Total: 1 location
1
Centre de Médecine Physique et de Réadaptation Bretegnier
Héricourt, Nord Franche-Comté, France, 70 400
Actively Recruiting
Research Team
J
Jean-Philippe JP Ehny, M.D
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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