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Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System

2014-08-27 03:13:59 | BioPortfolio

Summary

The objective of this study is to evaluate the efficacy and safety of surgical procedure involving ActiGait - implantable drop foot stimulator.

Description

Stroke is the third leading cause of death in the United States and other developed countries and a major source of disability. Prognosis for regaining the ability to walk is good, with 64% of those initially dependent in walking regaining independence by 3 months. However, many gait abnormalities persist. A conservative estimate suggests that 20% of stroke survivors have a drop foot. Drop foot following stroke is caused by paresis of the ankle dorsiflexor muscles. It prevents the patient from effectively swinging the leg during walking, causing an abnormal gait characterized by hip hitching and circumduction and toe catch. Walking speed in people with drop foot is often significantly reduced and the risk of stumbling or falling is high. The conventional treatment for drop foot is an ankle-foot orthosis (AFO). While AFOs are appropriate for many patients, in certain patient groups AFOs have significant limitations (e.g. in patients with strong spasticity, suffering from pronounced inversion, suffering from volume changes in the lower extremity, etc). An alternative way of treating drop foot is by means of functional electrical stimulation. Clinical studies evaluating the effectiveness of drop foot stimulation suggest that it provides many benefits to patients, such as an improved confidence in walking, increased walking speed and endurance, less effort during walking and reduced spasticity. Implantable systems such as ActiGait are considered therapeutic alternatives specifically for those patients for whom conventional treatments have failed. ActiGait system consists of an external module (antenna and control module), a foot switch transmitting to the external module and an implanted assembly (receiver, pulse train generator, electrodes). The objective of this study is to obtain additional evidence on safety of ActiGait implantation procedure and on its efficacy. The study will enrol 5 subjects that will be implanted and followed for 12 weeks. Efficacy outcomes will be assessed at the baseline and during two follow-up visits (week 6 and 12). Subjects will be asked to walk with and without their preferred walking at the baseline and with and without stimulation at follow-up visits.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Stroke

Intervention

ActiGait - implantable drop foot stimulator

Status

Completed

Source

Otto Bock Healthcare Products GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

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