Evaluation of the Increase of the Driving Speed With Walkaide® Medical Device (WALKAIDE)

December 23, 2015 updated by: University Hospital, Angers

Evaluation of the Increase of the Driving Speed After the Apparatus by Walkaide® Medical Device in Deficits Levator Foot of Central Origin.

Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.

The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotic and walking with orthotic Walkaide® medical devie after one month of training.

This is a prospective multicenter study, without control group, qualified as a biomedical research.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Passive ankle dorsiflexion of at least 0 ° (strained knee)
  • No injection of botulinum toxin in the lower limbs for at months 3 months
  • No surgery for at least three months
  • Walk 10 meters in less than 60 seconds, without human help, with or without technical assistance
  • Score the Functional Ambulation Classification (FAC) ≥ 3
  • Ashworth Score ≤ 2 sural triceps
  • Written consent signed

Exclusion Criteria:

  • Presence of severe cognitive impairment that does not allow the use of the device independently
  • History of debilitating disease associated general
  • Local embarrassing skin disorder laying the electrodes
  • Pacemaker
  • Unstable Epilepsy
  • Pregnancy and lactation
  • Participation Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WALKAIDE

A clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device.

Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device.
Device: WALKAIDE

A clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device.

Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in walking speed
Time Frame: One month
The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotics and walking with Walkaide® functionnal electric stimulation orthosis after one month of training.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Isabelle Richard, md-PHD, University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 24, 2015

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU PROMOTEUR 2013/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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