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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

Clinical Trials [1939 Associated Clinical Trials listed on BioPortfolio]

Implanted Drop Foot Stimulator for Hemiparetic Patients

The aim of this study is to investigate the effects of the implantable drop foot stimulator "ActiGait" (Ottobock Health Care, Duderstadt, Germany) on gait in hemiparetic patients. While se...

Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patien...

Efficacy of the WalkAide and AFOs for CVA

To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop. The comparison will involve physical measurements (e.g. walking speed, physiological cost index, ...

Ankle Robot to Reduce Foot-drop in Stroke

Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive cont...

WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

The purpose of this clinical trial is to establish equivalence or incremental benefit of the Walkaide device to standard of care Ankle Foot Orthosis (AFO) for patients with foot drop due t...

PubMed Articles [3127 Associated PubMed Articles listed on BioPortfolio]

Bipedal gait model for precise gait recognition and optimal triggering in foot drop stimulator: a proof of concept.

Electrical stimulators are often prescribed to correct foot drop walking. However, commercial foot drop stimulators trigger inappropriately under certain non-gait scenarios. Past researches addressed ...

Examination of factors related to the effect of improving gait speed with functional electrical stimulation intervention for patients with stroke.

Functional electrical stimulation (FES) for patients with stroke and foot drop is an alternative to ankle foot orthoses. Characteristics of FES responders and non-responders have not been clarified.

Functional electrical stimulation and ankle foot orthoses provide equivalent therapeutic effects on foot drop: A meta-analysis providing direction for future research.

To compare the randomized controlled trial evidence for therapeutic effects on walking of functional electrical stimulation and ankle foot orthoses for foot drop caused by central nervous system condi...

Flexor Hallucis Longus Transfer for Foot Drop without Functioning Tibialis Posterior.

For a foot drop resulting from peroneal nerve palsy transferring the tibialis posterior tendon is a standard surgical treatment. The situation of foot drop with no functioning tibialis posterior prese...

Walking measures to evaluate assistive technology for foot drop in multiple sclerosis: A systematic review of psychometric properties.

Foot drop in people with multiple sclerosis (pwMS) often managed with assistive technologies, such as functional electrical stimulation and ankle foot orthoses. No evidence synthesis exists for the ps...

Medical and Biotech [MESH] Definitions

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