Implanted Drop Foot Stimulator for Hemiparetic Patients

NCT03447717 | Completed

• 1 other identifier: 2126/2016
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gait, Hemiplegic

Keywords

hemiplegic gait; peroneal nerve stimulation; gait analysis

Outcome Measures

Primary Outcomes (1)

• kinematic gait parameters

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

  1 year

Secondary Outcomes (3)

• spatio-temporal parameters

  1 year

• 10-m-walking test

  1 year

• Visual Analogue Scale for Health

  1 year

Study Arms (1)

ActiGait

EXPERIMENTAL

Patients who get the ActiGait implant

Device: ActiGait

Interventions

ActiGait DEVICE

implanted device for peroneal nerve stimulation

ActiGait

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oskar C Aszmann, MD

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physitherapist, Researcher

Model Details: patients meeting the inclusion criteria are included

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: July 26, 2012
• Primary Completion: February 29, 2016
• Study Completion: February 29, 2016
• Last Updated: February 27, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: upon publication in a scientific journal
• Access Criteria: publically available