Implanted Drop Foot Stimulator for Hemiparetic Patients | NCT03447717

Studies
Implanted Drop Foot Stimulator for Hemiparetic Patients

NCT03447717

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Gait, Hemiplegic

Interventions

ActiGait

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2012Actual

Primary Completion Date

Feb 29, 2016Actual

Completion Date

Feb 29, 2016Actual

First Submitted Date

Feb 21, 2018

First Submission Date that Met QC Criteria

Feb 26, 2018

First Posted Date

Feb 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2018

Last Update Posted Date

Feb 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Agnes Sturma, Physitherapist, Researcher, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ActiGait	Experimental	Patients who get the ActiGait implant	Device: ActiGait

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ActiGait	Device	implanted device for peroneal nerve stimulation	ActiGait

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
kinematic gait parameters	Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.	1 year

Secondary Outcomes

Measure	Description	Time Frame
spatio-temporal parameters	Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.	1 year
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oskar C Aszmann, MD	Medical University of Vienna	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD from the mentioned outcome parameters are planned to be made available to other researchers.

Types

Not provided

Time Frame

upon publication in a scientific journal

Access Criteria

publically available

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020233	Gait Disorders, Neurologic

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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