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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02639689
Acronym
WALKAIDE
Enrollment
40
Registered
2015-12-24
Start date
2013-09-30
Completion date
2016-01-31
Last updated
2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Sensory Deficit

Keywords

Deficits of foot relievers of central origin, Walkaide

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.

Interventions

DEVICEWALKAIDE

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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in walking speedOne monthThe 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.

Countries

France

Contacts

Primary ContactIsabelle Richard Crémieux, Md-PHD
Isabelle.richard@univ-angers.fr0241351719
Backup ContactFlavie Frémondière, MD
flaviefremondiere@yahoo.fr0241351706

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026