Implanted Drop Foot Stimulator for Hemiparetic Patients
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|ClinicalTrials.gov Identifier: NCT03447717|
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gait, Hemiplegic||Device: ActiGait||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||patients meeting the inclusion criteria are included|
|Masking:||None (Open Label)|
|Official Title:||The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients|
|Actual Study Start Date :||July 26, 2012|
|Actual Primary Completion Date :||February 29, 2016|
|Actual Study Completion Date :||February 29, 2016|
Patients who get the ActiGait implant
implanted device for peroneal nerve stimulation
- kinematic gait parameters [ Time Frame: 1 year ]Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.
- spatio-temporal parameters [ Time Frame: 1 year ]Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.
- 10-m-walking test [ Time Frame: 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.
- Visual Analogue Scale for Health [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447717
|Study Director:||Oskar C Aszmann, MD||Medical University of Vienna|