Implanted Drop Foot Stimulator for Hemiparetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients

Conditions
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Gait, Hemiplegic

Intervention / Treatment
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* Device: ActiGait


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients meeting the inclusion criteria are included
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ActiGait<br>Patients who get the ActiGait implant | Device: ActiGait<br>* implanted device for peroneal nerve stimulation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiplegic gait, peroneal nerve stimulation, gait analysis