NCT02897752

Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients

Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for the Lower Extremities in Chronic Stroke Patients With Hemiplegia: A Multicenter, Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: The previous study resulted that the gait training using Functional Electrical Stimulation (FES) improved the ankle joint function and the walking ability for the chronic stroke patients with foot drop. In addition, the further exploratory study in multicenter obtained the result that the training with WA were especially good adaptation to the patients who have slight paralysis and can walk independently. PURPOSE: This multicenter prospective trial is studying to reveal whether the gait training with the WalkAide\[R\](WA) for chronic stroke patients who can walk independently is superior to gait training with a physical therapist.

Detailed description

OBJECTIVE: To reveal whether gait training with the WA for chronic stroke patients who can walk independently (Functional Ambulation Classification \[FAC\] 5 or 6) is superior to gait training with a physical therapist. OUTLINE: This is a multicenter study. Patients continue gait training with WA or without WA for 4 weeks. The effect of rehabilitation is evaluated by 6 Minute Walk Test without device.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	gait training with WA	Thirty seven units (1 unit=20 minutes) of gait training with WA by a physical therapist for the WA group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.
OTHER	usual gait training	Thirty seven units of usual gait training by a physical therapist for the UT group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.

Timeline

• Start date: 2016-03-23
• Primary completion: 2017-12-07
• Completion: 2017-12-07
• First posted: 2016-09-13
• Last updated: 2018-04-18

Locations

24 sites across 1 country: Japan