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

NCT02639689 | Unknown Phase 1

• 1 other identifier: CHU PROMOTEUR 2013/12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Foot Sensory Deficit

Keywords

Deficits of foot relievers of central origin; Walkaide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

WALKAIDE

EXPERIMENTAL

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

Interventions

WALKAIDE DEVICE

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.

WALKAIDE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Les Capucins

Angers, Pays de la Loire Region, 49103, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 19846759 RESULT

• 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.

  PMID: 14654207 RESULT

• 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.

  PMID: 15153151 RESULT

• 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.

  PMID: 19861590 RESULT

• 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.

  PMID: 20692180 RESULT

Study Officials

• Isabelle Richard, md-PHD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Richard Crémieux, Md-PHD

CONTACT

0241351719; Isabelle.richard@univ-angers.fr

Flavie Frémondière, MD

CONTACT

0241351706; flaviefremondiere@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 24, 2015
• Study Start: September 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

FR (1)