Implanted Drop Foot Stimulator for Hemiparetic Patients

Gait, Hemiplegic Clinical Trial

Official title:

The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447717
• Other study ID #: 2126/2016
• Status: Completed
• Phase: N/A
• First received: February 21, 2018
• Last updated: February 26, 2018
• Start date: July 26, 2012
• Est. completion date: February 29, 2016

Study information

• Verified date: February 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic

Intervention

Device:
• ActiGait
implanted device for peroneal nerve stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kinematic gait parameters	Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.	1 year
Secondary	spatio-temporal parameters	Spatio-temproal parameters are recorded and analysed using a 3D VICON infra-red camera system.	1 year
Secondary	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.	1 year
Secondary	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).	1 year