Botulinum toxin A, functional electrical stimulation, and physiotherapy in the treatment of spastic dropped foot in subacute stroke.

Completed

Phase N/A Results

Trial Description

To assess the efficacy of botulinum toxin A (Dysport) in conjunction with functional electrical stimulation (FES) and physical therapy, in restoring normal gait to post-stroke patients with spastic foot drop.

Interventions

  • Botulinum toxin (Dysport)Drug
    Other Names: botulinum toxin injection for post stroke spasticity
    Intervention Desc: Antispasticity agent.
  • Physical therapy Behavioral
  • Electrical stimulation Device
    Intervention Desc: This category includes any form of electrical stimulation intended to improve motor function or pain after stroke.

Trial Design

Multicenter, randomized, controlled study

Patient Involvement

Patients in both the control and treatment groups underwent a 4-week assessment period, and received physical therapy throughout the trial. The treatment group also received FES stimulation of the peroneal nerve and 800 U injections of botulinum toxin A delivered to the triceps surae under EMG guidance.

Outcomes

Type Measure Time Frame Safety Issue
Primary Mean walking speed
Secondary Physiological Cost Index, Rivermead Motor Assessment Scale, Modified Ashworth, Barthel Index, and SF 36 Health Survey scores were recorded, as well as clonus and the patients' reflexes. Semi-structured interviews were also performed.

Sponsors

IPSEN