Implanted Drop Foot Stimulator for Hemiparetic Patients

NCT ID: NCT03447717

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-26
• Study Completion Date: 2016-02-29

Brief Summary

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 several studies investigated the effects of implanted systems on walking speed and gait endurance, only a few studies have focused on the system's impact on kinematics and long-term outcomes. Therefore, our aim was to further investigate the effects of the implanted system ActiGait on gait kinematics and spatiotemporal parameters with a 1-year follow-up period.

Detailed Description

Patients with a neurologic condition leading to drop foot during swing phase in gait are treated by the implentation of the AcitGait system (which has a CE-certificate in Europe).

The aim of this study is to investigate the effect of the device on gait with a follow-up period of one year. Patients are assessed before implantation and at one-year follow up. At baseline, they are asked to walk without any assistive device, as well as with surface electrical stimulation of the peroneal nerve. At follow-up, they are asked to walk with the ActiGait system switched off and switched on.

Outcome assessments include a 10m-walking test and gait analysis with a VICON 3D-camera system. This allows to extract spatio-temporal parameters (as steps per minute, step length,...) as well as kinematic data (e.g. joint ankles during the gait cycle). All outcome data is analyzed using statistical tests.

Conditions

Gait, Hemiplegic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ActiGait

Patients who get the ActiGait implant

Group Type: EXPERIMENTAL

ActiGait

Intervention Type: DEVICE

implanted device for peroneal nerve stimulation

Interventions

ActiGait

implanted device for peroneal nerve stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• drop foot after stroke, brain haemorrhage or multiple sclerosis
• a minimum of six months after the acute infarction/onset of the disease
• passive extension of the ankle to at least at neutral position
• no sufficient active ankle extension
• free walking without any aid for at least 20 meters in less than 2 minutes
• a walking speed of ≤ 1,2m/sec (measured with 10 meter walking test)
• use of surface electrical stimulation for at least three months
• be able to stand freely

Exclusion Criteria

• damage to the peripheral nervous system
• epilepsy
• adiposity
• substance abuse
• no cognitive ability to follow the study instructions
• pregnancy
• use of other implanted devices
• instable ankle joint or fixed contracture

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Agnes Sturma

Physitherapist, Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oskar C Aszmann, MD

Role: STUDY_DIRECTOR

Medical University of Vienna

Other Identifiers

2126/2016

Identifier Type: -

Identifier Source: org_study_id