Trial · NCT03119948
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in maximum speed of barefoot ambulation without technical assistance over 10 meters, between the pre-injection visit (D1) and 3 weeks (D21) post injection | Preinjection visit (D1) and 3 weeks post injection (D21) | |
| Secondary | Change ambulation speed at comfortable and maximal speed, barefoot and with shoes over 10 meters | Day 1 and Day 21 | |
| Secondary | Maximal amplitude and speed of active hip flexion and passive knee flexion during swing phase, measured in gait kinematic recording, at comfortable and maximal speed | Day 1 and Day 21 | |
| Secondary | Maximal amplitude and speed of passive ankle dorsiflexion at late stance phase, measured in gait kinematic recording, at comfortable and maximal speed | Day 1 and Day 21 | |
| Secondary | Maximal voluntary isometric EMG (MVIE) of rectus femoris and soleus, measured by surface EMG, in an isometric position with hip at 15° flexion, knee at 30° flexion, and ankle at 80° of dorsiflexion | Day 1 and Day 21 | calculating the mean rectified voltage over 100 ms around the peak of rectified EMG on each of these muscles |
| Secondary | Mean rectified voltage of rectus femoris and soleus during the first half of swing phase (MRVSP), from toe-off to maximal hip flexion, measured by surface EMG (electrodes 2 cm apart) immediately after MVIE measure. | Day 1 and Day 21 | |
| Secondary | Cocontraction indices of rectus femoris and soleus during the first half of swing phase, calculating the ratio MRVSP/MVIE for each of these muscles. | Day 1 and Day 21 | |
| Secondary | Mean rectified voltage of soleus during the first half of stance phase (MRVSP), from heel-on to maximal knee extension, measured by surface EMG (electrodes 2 cm apart) immediately after MVIE measure. | Day 1 and Day 21 | |
| Secondary | Inappropriate Contraction Indices of soleus during the first half of stance phase, calculating the ratio MRVSP / MVIE | Day 1 and Day 21 | |
| Secondary | Spasticity Angle et grade of rectus femoris and soleus (Five Step Assessment) | Day 1, Day 21, Day 60 | |
| Secondary | Weakness Angle of rectus femoris and soleus (Five Step Assessment) | Day 1, Day 21, Day 60 | |
| Secondary | Quality of life measured by EQ5D | Day 1, Day 60 | |
| Secondary | Mean weekly number of steps | Between Day-15 and Day1, Day7 and Day21 and between Day45 and Day60 | |
| Secondary | Potential AEs of injections (pain or discomfort during the injection or post injection, or ecchymoses at insertion site) and potential AEs related to the injected drug (muscle weakening, allergies) | Day 1, Day 21, Day 60 | |
| Secondary | Step length at comfortable and maximal speed, barefoot and with shoes over 10 meters | Day 1 and Day 21 | |
| Secondary | Step cadence at comfortable and maximal speed, barefoot and with shoes over 10 meters | Day 1 and Day 21 | |
| Secondary | Physiological Cost Index (PCI) over a walking test of 2 minutes at maximal speed with shoes | Day 1 and Day 21 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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