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

Sponsor

University Hospital, Angers (Other)

Overall Status

Unknown status

CT.gov ID

NCT02639689

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Change in walking speed [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Les Capucins	Angers	Pays de la Loire	France	49103

Sponsors and Collaborators

University Hospital, Angers

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT02639689

Other Study ID Numbers:

CHU PROMOTEUR 2013/12

First Posted:

Dec 24, 2015

Last Update Posted:

Dec 24, 2015

Last Verified:

Dec 1, 2015

Keywords provided by University Hospital, Angers

Deficits of foot relievers of central origin

Walkaide

Study Results

No Results Posted as of Dec 24, 2015