Clinical trial NCT02639689: Evaluation of the Increase of the Driving Speed With Walkaide® Medical Device
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Foot Sensory Deficit
Keywords: Deficits of foot relievers of central origin
Walkaide
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in walking speed
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Les Capucins
state: Pays de la Loire
Study officials:
affiliation: University Hospital, Angers
name: Isabelle Richard, md-PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein RB, Everaert DG, Thompson AK, Chong SL, Whittaker M, Robertson J, Kuether G. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair. 2010 Feb;24(2):152-67. doi: 10.1177/1545968309347681. Epub 2009 Oct 21.
citation: Detrembleur C, Dierick F, Stoquart G, Chantraine F, Lejeune T. Energy cost, mechanical work, and efficiency of hemiparetic walking. Gait Posture. 2003 Oct;18(2):47-55. doi: 10.1016/s0966-6362(02)00193-5.
citation: Kottink AI, Oostendorp LJ, Buurke JH, Nene AV, Hermens HJ, IJzerman MJ. The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review. Artif Organs. 2004 Jun;28(6):577-86. doi: 10.1111/j.1525-1594.2004.07310.x.
citation: Everaert DG, Thompson AK, Chong SL, Stein RB. Does functional electrical stimulation for foot drop strengthen corticospinal connections? Neurorehabil Neural Repair. 2010 Feb;24(2):168-77. doi: 10.1177/1545968309349939. Epub 2009 Oct 27.
citation: Sabut SK, Lenka PK, Kumar R, Mahadevappa M. Effect of functional electrical stimulation on the effort and walking speed, surface electromyography activity, and metabolic responses in stroke subjects. J Electromyogr Kinesiol. 2010 Dec;20(6):1170-7. doi: 10.1016/j.jelekin.2010.07.003. Epub 2010 Aug 6.