Implanted Drop Foot Stimulator for Hemiparetic Patients

Not Applicable

Completed

• Conditions: Gait, Hemiplegic
• Interventions: Device: ActiGait

• Registration Number: NCT03447717
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2012-07-26
• Primary Completion: 2016-02-29
• Study Completion: 2016-02-29
• Status Verified: 2018-02
• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-26
• Last Update Submitted: 2018-02-26
• Study First Posted: 2018-02-27
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ActiGait	ActiGait	Patients who get the ActiGait implant

Primary Outcome Measures

Name	Time	Method
kinematic gait parameters	1 year	Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.

Secondary Outcome Measures

Name	Time	Method
spatio-temporal parameters	1 year	Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.
Visual Analogue Scale for Health	1 year	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).
10-m-walking test	1 year	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.