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

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ClinicalTrials.gov Identifier: NCT02639689
Recruitment Status : Unknown
Verified December 2015 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease Intervention/treatment Phase
Foot Sensory Deficit Device: WALKAIDE Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Increase of the Driving Speed After the Apparatus by Walkaide® Medical Device in Deficits Levator Foot of Central Origin.
Study Start Date : September 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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.





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639689


Contacts
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Contact: Isabelle Richard Crémieux, Md-PHD 0241351719 ext 33 Isabelle.richard@univ-angers.fr
Contact: Flavie Frémondière, MD 0241351706 ext 33 flaviefremondiere@yahoo.fr

Locations
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France
Les Capucins Recruiting
Angers, Pays de la Loire, France, 49103
Contact: Isabelle PI Richard-Crémieux, Md-PHD    02 41 35 17 19 ext 33    Isabelle.richard@univ-angers.fr   
Contact: Flavie IV Frémondière, MD    02 31 35 17 06 ext 33    flaviefremondiere@yahoo.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Isabelle Richard, md-PHD University Hospital, Angers
Additional Information:
Publications of Results:
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02639689    
Other Study ID Numbers: CHU PROMOTEUR 2013/12
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Keywords provided by University Hospital, Angers:
Deficits of foot relievers of central origin
Walkaide