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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 (NCT02897752)

Moji Medical Center, Kyusyu Rosai Hospital
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.
  • 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.
      Ages eligible for Study
      all
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • 1)First-ever hemiplegic patients 4 months after the stroke onset
      • 2)Patients whose the lower extremity paralysis is estimated to be stage IV, V or VI according to the Brunnstrom stage
      • 3)Patients whose spasticity of the plantar flexor muscle is estimated at 2 or less according to the Modified Ashworth Scale
      • 4)Patients whose ankle dorsiflexion range of motion is 0 degree or more
      • 5)Patients whose gait performance is estimated to be 5 or 6 according to the FAC
      • 6)Patients who can understand the purpose and instructions of this study and complete the training
      • 7)Patients who agree to participate in this study and provide their written informed consent
      Exclusion Criteria:
      • 1)Patients whose ankle dorsiflexion is not induced by the WA due to peripheral neuropathy
      • 2)Patients who are contraindicated for the WA (e.g., patients with a metallic implant or implantable medical electrical equipment such as a cardiac pacemaker, and patients with a previous or suspected history of seizure)
      • 3)Patients who underwent Botox treatment in the lower extremities within 3 months of this study registry
      • 4)Patients who have nervous system (excluding stroke), cardio-respiratory system, or musculoskeletal system disorders, which may affect gait and training
      • 5)Patients who had fallen down within a week prior to the registry and are regarded to be at a high risk of falling down by an attending physician
      • 6)Patients whose impairment severities changed between the prior and initial assessments
      • Definition of an alteration
      • Brunnstrom stage for the lower extremity: Confirm whether the stages of the prior and initial assessments are the same value. If these stages are different, this is considered to be an alteration, and the patient with this alteration should be excluded from the study.
      • Lower extremity subscale of the Fugl-Meyer Assessment: Confirm whether the change in the score between the prior and initial assessments is 5 or less. If the change is 6 or more, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study.
      • Functional Ambulation Classification: Confirm whether the categories of the prior and initial assessments are the same value. If these categories are different, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study.
      • 7) Patients who are regarded to be ineligible for this study by the principal investigator or co-investigators
      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.

      24 locations

      Japan (24)
      • Fukuoka Mirai Hospital
        recruiting
        Fukuoka-city, Fukuoka-prefecture, Japan, 813-0017
      • Nagao Hospital
        recruiting
        Fukuoka-city, Fukuoka-prefecture, Japan, 814-0153
      • Hakujuji Hospital
        recruiting
        Fukuoka-city, Fukuoka-prefecture, Japan, 819-8511
      • Kitakyushu Abeyamakouen Hospital
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 800-0257
      • Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 801-8502
      • Tobata Rehabilitation Hospital
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 804-0092
      • Kitakyushu Yahata Higashi Hospital
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 805-0061
      • Shin-Oji Hospital
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 806-0057
      • Tochiku Hospital
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 807-0856
      • Hospital of the University of Occupational and Environmental Health, Japan
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 807-8555
      • Yoshino Hospital
        recruiting
        Kitakyusyu-city, Fukuoka-prefecture, Japan, 808-0034
      • Sapporo Shiroishi Memorial Hospital
        recruiting
        Sapporo-city, Hokkaido-prefecture, Japan, 003-0026
      • Tokeidai Memorial Hospital
        recruiting
        Sapporo-city, Hokkaido-prefecture, Japan, 060-0031
      • Hyogo Prefectural Rehabilitation Central Hospital
        recruiting
        Kobe-city, Hyogo-prefecture, Japan, 651-2181
      • Yoshida Hospital, Cerebrovascular Research Institute
        recruiting
        Kobe-city, Hyogo-prefecture, Japan, 652-0803
      • Yamaga Onsen Rehabilitation Hospital
        recruiting
        Yamaga-city, Kumamoto-prefecture, Japan, 861-0514
      • Nichinan Municipal Chubu Hospital
        recruiting
        Nichinan-city, Miyazaki-prefecture, Japan, 889-3141
      • Nagasakikita Hospital
        recruiting
        Nishisonogi-gun, Nagasaki-prefecture, Japan, 851-2103
      • Beppu Rehabilitation Center
        recruiting
        Beppu-city, Oita-prefecture, Japan, 874-8611
      • Ginowan Memorial Hospital
        recruiting
        Ginowan-city, Okinawa-prefecture, Japan, 901-2211
      • Chuzan Hospital
        recruiting
        Okinawa-city, Okinawa-prefecture, Japan, 904-2151
      • Nanbu-Tokushukai Hospital
        recruiting
        Shimajiri-gun, Okinawa-prefecture, Japan, 901-0493
      • Saitama Misato Sogo Rehabilitation Hospital
        recruiting
        Misato-city, Saitama-prefecture, Japan, 341-0034
      • Showa Hospital
        recruiting
        Shimonoseki-city, Yamaguchi-prefecture, Japan, 750-0059
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 December, 2015
      Updated:
      12 June, 2017
      Participants:
      120
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