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

Completed

Phase N/A Results

Trial Description

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

Detailed 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.

Conditions

Interventions

  • ActiGait - implantable drop foot stimulator Device
    ARM 1: Kind: Experimental
    Label: ActiGait - implantable drop foot stimulator
  • ActiGait Device
    Intervention Desc: ActiGait - implantable drop foot stimulator
    ARM 1: Kind: Experimental
    Label: ActiGait
    Description: Receiving ActiGait - implantable drop foot stimulator

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in 6 minute walk test post-implantation Week 12 post-implantation No
Primary Percentage of subjects that experience serious adverse device effects following implantation as a measure of safety 12 weeks following the implantation Yes
Secondary Change is 10 meter gait test post-implantation Week 12 post-implantation No
Secondary Change is Canadian Occupational Performance Measure (COPM) score post-implantation Week 12 post-implantation No
Secondary Change in Four Square Step Test (FSST) post-implantation Week 12 post-implantation No
Secondary Change in nerve conduction velocity of the peroneal nerve post-implantation Week 12 post-implantation Yes
Secondary Change in MRI of affected leg and implant post-implantation Week 3 post-implantation Yes
Primary Distance Walked in 6 Minutes Baseline, 6 and 12 weeks post-implantation No
Secondary Walking Speed During 10 Meter Gait Test Baseline, 6 and 12 weeks post-implantation No
Secondary Canadian Occupational Performance Measure (COPM) Score Baseline,12 weeks post-implantation No
Secondary Four Square Step Test (FSST) Baseline, week 12 post-implantation No
Secondary Nerve Conduction Velocity of the Peroneal Nerve Baseline, week 12 post-implantation Yes

Sponsors