Upper-limb Active Function and Botulinum Toxin a
NCT03783572 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-10-23
Summary
This study in an observational, prospective and longitudinal study. The aim of the study is to evaluate the effect of botulinum toxin type A (BTX) injections into the elbow flexors on the reduction of spastic co-contractions (spastic co-contraction index, SCCI) during an active elbow extension in chronic post-stroke patients.TBA injections are performed as part of routine care
Conditions
- Stroke
- Muscle Spasticity
- Upper Extremity Paralysis
Interventions
- OTHER
-
Clinical evaluation
For the control group : only one clinical evaluation : search for non-inclusion criteria and manual laterality score
- OTHER
-
Clinical evaluation and Instrumental evaluation
For the patient : The standard clinical examination to evaluate movement : pain, motive power, spasticity plus Edinburgh's laterality score and Sensitivity deficiency by the Erasmus Nottingham Sensory Assessment (EmNSA) score and the evaluation of the cognitive function An encephalic MRI An instrumental evaluation : with concomitant recording of 3D kinematic data, surface and intramuscular EMG of the flexor and elbow extensor muscles, and EEG during active elbow extension, paretic and non-paretic movements.
Sponsors & Collaborators
-
University Hospital, Toulouse
lead OTHER
Principal Investigators
-
David Gasq, MD · University Hospital, Toulouse
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-12-08
- Primary Completion
- 2027-12-30
- Completion
- 2027-12-30
Countries
- France
Study Locations
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