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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
Sponsor:
Information provided by (Responsible Party):
Agnes Sturma, 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.

Condition or disease Intervention/treatment Phase
Gait, Hemiplegic Device: ActiGait Not Applicable

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.


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: ActiGait
Patients who get the ActiGait implant
Device: ActiGait
implanted device for peroneal nerve stimulation




Primary Outcome Measures :
  1. kinematic gait parameters [ Time Frame: 1 year ]
    Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.


Secondary Outcome Measures :
  1. spatio-temporal parameters [ Time Frame: 1 year ]
    Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.

  2. 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.

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Director: Oskar C Aszmann, MD Medical University of Vienna

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Responsible Party: Agnes Sturma, Physitherapist, Researcher, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03447717     History of Changes
Other Study ID Numbers: 2126/2016
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
Time Frame: upon publication in a scientific journal
Access Criteria: publically available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Agnes Sturma, Medical University of Vienna:
hemiplegic gait
peroneal nerve stimulation
gait analysis

Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms