Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients
NCT02897752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2018-04-18
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Moji Medical Center, Kyusyu Rosai Hospital
collaborator UNKNOWN -
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
lead OTHER
Principal Investigators
-
Kenji Hachisuka, MD, Ph.D · Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-23
- Primary Completion
- 2017-12-07
- Completion
- 2017-12-07
Countries
- Japan
Study Locations
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