Implanted Drop Foot Stimulator for Hemiparetic Patients

The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in 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 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.

Study Overview

• Status: Completed
• Conditions: Gait, Hemiplegic
• Intervention / Treatment: Device: ActiGait

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ActiGait; Patients who get the ActiGait implant	Device: ActiGait; implanted device for peroneal nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kinematic gait parameters	Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spatio-temporal parameters	Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.	1 year
10-m-walking test	The 10-m-walking test is a standardised clinical test where the patient is asked to walk for 10m at the fastest convenient walking speed and time is taken.	1 year
Visual Analogue Scale for Health	Using a 100mm Visual Analogue Scale (VAS) patients are asked to mark their current health status between 0 (worst possible health) and 100 (best possible health).	1 year

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Director: Oskar C Aszmann, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2012
• Primary Completion (Actual): February 29, 2016
• Study Completion (Actual): February 29, 2016

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: gait analysis; hemiplegic gait; peroneal nerve stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: 2126/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
• IPD Sharing Time Frame: upon publication in a scientific journal
• IPD Sharing Access Criteria: publically available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No