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Implanted Drop Foot Stimulator for Hemiparetic Patients

Primary Purpose

Gait, Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ActiGait
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait, Hemiplegic focused on measuring hemiplegic gait, peroneal nerve stimulation, gait analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ActiGait

    Arm Description

    Patients who get the ActiGait implant

    Outcomes

    Primary Outcome Measures

    kinematic gait parameters
    Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.

    Secondary Outcome Measures

    spatio-temporal parameters
    Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.
    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.
    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).

    Full Information

    First Posted
    February 21, 2018
    Last Updated
    February 26, 2018
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03447717
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 26, 2012 (Actual)
    Primary Completion Date
    February 29, 2016 (Actual)
    Study Completion Date
    February 29, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gait, Hemiplegic
    Keywords
    hemiplegic gait, peroneal nerve stimulation, gait analysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    patients meeting the inclusion criteria are included
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ActiGait
    Arm Type
    Experimental
    Arm Description
    Patients who get the ActiGait implant
    Intervention Type
    Device
    Intervention Name(s)
    ActiGait
    Intervention Description
    implanted device for peroneal nerve stimulation
    Primary Outcome Measure Information:
    Title
    kinematic gait parameters
    Description
    Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    spatio-temporal parameters
    Description
    Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.
    Time Frame
    1 year
    Title
    10-m-walking test
    Description
    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.
    Time Frame
    1 year
    Title
    Visual Analogue Scale for Health
    Description
    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).
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oskar C Aszmann, MD
    Organizational Affiliation
    Medical University of Vienna
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
    IPD Sharing Time Frame
    upon publication in a scientific journal
    IPD Sharing Access Criteria
    publically available

    Learn more about this trial

    Implanted Drop Foot Stimulator for Hemiparetic Patients

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