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

Phase 1

• Conditions: Foot Sensory Deficit
• Interventions: Device: WALKAIDE

• Registration Number: NCT02639689
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09
• Status Verified: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-23
• Last Update Submitted: 2015-12-23
• Study First Posted: 2015-12-24
• Last Update Posted: 2015-12-24
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WALKAIDE	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

Name	Time	Method
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.

Trial Locations

Locations (1)

Les Capucins; 🇫🇷 Angers, Pays de la Loire, France