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

Recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Gait training with WA Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: WalkAide
  • Usual gait training Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual gait Training

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort) 4weeks No
Secondary Lower extremity subscale of the Fugl-Meyer Assessment 4weeks No
Secondary Muscle strength of the ankle dorsiflexor muscle 4weeks No
Secondary Ankle dorsiflexion range of motion 4weeks No
Secondary Modified Ashworth Scale for the plantar flexor muscle 4weeks No
Secondary 10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed). 4weeks No
Secondary Stroke Impact Scale 4weeks No
Secondary Adverse event assessment 4weeks Yes

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