Actively Recruiting
A Randomized Study Comparing Surgery and Physiotherapy for Foot Drop Caused by Peroneal Nerve Entrapment
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
182
Participants Needed
18
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying foot drop caused by peroneal nerve entrapment to determine if decompressive surgery is more effective than maximal conservative treatment. This trial is prospective, multi-center, and randomized, focusing on patients with persistent foot drop lasting about 10 weeks after symptom onset. The study aims to compare recovery in muscle strength and walking ability, with the main measure being the distance walked in six minutes, evaluated 9 months after treatment begins. Participants will be randomly assigned to either decompressive surgery performed within one week after randomization or to conservative treatment involving physiotherapy and gait rehabilitation. Those in the surgical group undergo neurolysis to release the nerve, while the conservative group receives standard care without surgery until the primary endpoint is reached. Follow-up visits occur at multiple time points including 10 days for surgery, 6 weeks, 3, 6, 9, and 18 months to monitor progress. During the study, participants will complete various questionnaires and undergo assessments of muscle strength, gait performance, quality of life, and electrodiagnostic tests. Researchers will track recovery through tests like the six-minute walk and 10-meter walk, muscle strength scores, and patient-reported outcomes. Safety and complications will be monitored throughout, and participants will be observed for up to 18 months post-randomization to gather extended follow-up data.
CONDITIONS
Brief Title
Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
Research Team
C
Christophe Oosterbos, M.D.
T
Tom Theys, M.D.; Ph.D.
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