Effect of Repeated Injections of Higher Doses of Botulinum Toxin on Lower Limb of Spastic Hemiplegic Patients on Gait.
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study ID
- NCT04544280
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Xeomin Injectable Product — DRUGIntramuscular injection
Study Details
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
Key Dates
- Start date
- Sep 13, 2018
- Status verified
- Aug 2023
- Primary completion
- Dec 31, 2021
- Completion
- Dec 31, 2021
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention
Primary Outcome Measure
Temporo-spatial parameters of gait [ Time Frame: 7-9 months ]
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