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

Phase 1

• Conditions: Foot Sensory Deficit

• 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

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