Partial Blocks of Rectus Femoris and Soleus With Botulinum Toxin Type A to Improve Gait in Hemiparesis. A Randomized Multicenter Placebo-controlled Trial (GENUFLEX)

NCT03119948 Phase 2 UNKNOWN

The most common motor deficiency after stroke or traumatic brain injury is hemiparesis. Most hemiparetic patients recover walking, but rarely with a speed permitting easy ambulation outdoors with family or friends. One of the mechanisms of gait impairment in hemiparesis is insufficient active hip flexion during swing phase, which leads to insufficient ground clearing at swing phase, with associated gait slowness and risks of fall. The main hypothesis behind the present study is that insufficient hip flexion during hemiparetic gait is partly due to overactivity of rectus femoris. Focal treatment of lower limb muscle overactivity using botulinum toxin has not been demonstrated to increase walking speed in hemiparesis as yet. However, most studies have focused distally, on improving foot dorsiflexion only. The purpose of this study is to compare the effects of botulinum toxin injection and placebo in rectus femoris (RF) + plantar flexors versus plantar flexors only.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2
Status	UNKNOWN
Enrolment	66
Start date	2014-12
Completion	2018-12

Conditions

• Hemiparesis After Stroke
• Traumatic Brain Injury

Interventions

• Placebo injection
• Botulinum toxin injection
• Placebo injection and botulinum toxin injection

Primary outcomes

• 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)

Countries

France