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

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

Detailed Description
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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.

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

Conditions
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Foot Sensory Deficit

Intervention / Treatment
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* Device: WALKAIDE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WALKAIDE<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deficits of foot relievers of central origin, Walkaide