Clinical trial NCT03447717: Implanted Drop Foot Stimulator for Hemiparetic Patients
Official title: The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Hemiplegic
Keywords: hemiplegic gait
peroneal nerve stimulation
gait analysis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients meeting the inclusion criteria are included
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: kinematic gait parameters
timeFrame: 1 year
Secondary outcomes:
measure: spatio-temporal parameters
timeFrame: 1 year
measure: 10-m-walking test
timeFrame: 1 year
measure: Visual Analogue Scale for Health
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Oskar C Aszmann, MD
role: STUDY_DIRECTOR
References: