Restoration of ankle movements with the ActiGait implantable drop foot stimulator: a safe and reliable treatment option for permanent central leg palsy

Abstract

OBJECT The ActiGait drop foot stimulator is a promising technique for restoration of lost ankle function by an implantable hybrid stimulation system. It allows ankle dorsiflexion by active peroneal nerve stimulation during the swing phase of gait. In this paper the authors report the outcome of the first prospective study on a large number of patients with stroke-related drop foot. METHODS Twenty-seven patients who experienced a stroke and with persisting spastic leg paresis received an implantable ActiGait drop foot stimulator for restoration of ankle movement after successful surface test stimulation. After 3 to 5 weeks, the stimulator was activated, and gait speed, gait endurance, and activation time of the system were evaluated and compared with preoperative gait tests. In addition, patient satisfaction was assessed using a questionnaire. RESULTS Postoperative gait speed significantly improved from 33.9 seconds per 20 meters to 17.9 seconds per 20 meters (p < 0.0001), gait endurance from 196 meters in 6 minutes to 401 meters in 6 minutes (p < 0.0001), and activation time from 20.5 seconds to 10.6 seconds on average (p < 0.0001). In 2 patients with nerve injury, surgical repositioning of the electrode cuff became necessary. One patient showed a delayed wound healing, and in another patient the system had to be removed because of a wound infection. Marked improvement in mobility, social participation, and quality of life was confirmed by 89% to 96% of patients. CONCLUSIONS The ActiGait implantable drop foot stimulator improves gait speed, endurance, and quality of life in patients with stroke-related drop foot. Regarding gait speed, the ActiGait system appears to be advantageous compared with foot orthosis or surface stimulation devices. Randomized trials with more patients and longer observation periods are needed to prove the long-term benefit of this device.

ActiGait implantable drop foot stimulator in multiple sclerosis: a new indication

“…The aim of this study was to elucidate whether the Ac-tiGait implantable drop foot stimulator can provide longterm improvements in gait speed and endurance and re- duce the risk of falls in patients with MS-related drop foot, because its efficacy and superiority over surface stimulation in patients after stroke were reported recently. 10,16 In this study, no adverse events were observed. Until now, only rare complications, such as hematoma and lymphedema (both in 1 of 5 patients), 16 wound-healing deficit (1 of 15 patients) and infections (2 of 15 patients), 3 and injury to the peroneal nerve (2 of 27 patients), 10 have been reported.…”

“…10,16 In this study, no adverse events were observed. Until now, only rare complications, such as hematoma and lymphedema (both in 1 of 5 patients), 16 wound-healing deficit (1 of 15 patients) and infections (2 of 15 patients), 3 and injury to the peroneal nerve (2 of 27 patients), 10 have been reported. The surgery and postoperative care were easy and uncomplicated.…”

“…For this study, the patients underwent implantation of the ActiGait system, which consists of an implantable 4-channel drop foot stimulator, an external control unit, a footswitch, and a clinical station [2][3][4]9,10 (Fig. 1).…”

The long-term effects of an implantable drop foot stimulator on gait in hemiparetic patients

“…During the past decade a few studies have investigated the effects of implanted systems on gait [27–32] and quality of life [26, 30, 32]. Most of them found an increase in walking speed and dorsal extension of the ankle during swing phase and/or initial contact as well as good patient-reported device satisfaction and improved quality of life.…”

Funktionelle Elektrostimulation als Therapie des neurogenen Fallfußes

“…So wird z. B. in der vergleichbaren Studie mit einem implantierbaren Stimulator von Martin et al eine deutliche Verbesserung der Ganggeschwindigkeit von 47,2 % beschrieben[10]. Ebenso beschreiben Studien, die das Outcome von ex-…”