Implanted Drop Foot Stimulator for Hemiparetic Patients
Primary Purpose
Gait, Hemiplegic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ActiGait
Sponsored by
About this trial
This is an interventional treatment trial for Gait, Hemiplegic focused on measuring hemiplegic gait, peroneal nerve stimulation, gait analysis
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
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
NCT ID
NCT03447717
First Posted
February 21, 2018
Last Updated
February 26, 2018
Sponsor
Medical University of Vienna
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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