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The Therapeutic Effects of Peroneal Nerve Functional Electric Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia A Randomized Controlled Study (NCT02898168)

Kagoshima University
Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in the daily life of patients. It is considered significant effects on their Quality of Life(QOL). Further methods of rehabilitation are required for convalescent patients to recover their function soon and better, due to a multitudes of recovery patient with troubles such as gait problem. This trial is studying to investigate the effects of gait training with a functional electrical stimulation (FES) `WalkAide[R](WA)' to improve the lower-limb function and ambulation in convalescent stroke patients.
  • Device: WA group
    Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.
    • Other: Control
      Conventional rehabilitation therapy and gait training without WA.
      Ages eligible for Study
      20 Years to 85 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • 1) Patients who agree to participate in this study and provide their informed consent
      • 2) Patients from 20 to 85 years old at the time of consent
      • 3) Patients of convalescent stoke (within 6 months of onset)
      • 4) Patients with a first episode of stroke, which type limited intracranial hemorrhage or ischemic stroke (excluding subarachnoid hemorrhage)
      • 5) Patients inpatients for the rehabilitation therapy
      • 6) Patients diagnosed 3 or 4 on Functional Ambulation Classification (FAC)
      • 7) Patients stable general condition(blood pressure, pulse, blood glucose level etc.)
      • 8) Patients with drop foot in walking
      Exclusion Criteria:
      • 1) Patients due to severe heart disease
      • 2) Patients with previous gait disability, such as neurological disease
      • 3) Patients with previous orthopedic disease, such as knee osteoarthritis
      • 4) Patients with severe hepatic or renal dysfunction
      • 5) Patients with severe sensory disturbance or severe ataxia or severe higher brain dysfunction
      • 6) Patients correspond to contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker)
      • 7) Patients with severe skin disease
      • 8) Patients with any dose adjustment of antispasticity drugs (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) within 1month
      • 9) Patients whose impairment severities changed during the study period
      • 10) Patients taking the botulinum toxin formulation injection or the nerve block injection with phenol within 6months
      • 11) Patients with any lower limb treatment using FES or the robot suit within 1month
      • 12) Patients diagnosed not to use during the the WA trial operation period
      • 13) Patients who do not complete the WA trial operation for 7 days
      • 14) Patients joining any other clinical trials or studies with intervention
      This study is targeting convalescent patients within 6 months after the onset of initial stroke (cerebral infarction or cerebral hemorrhage) and also observing the foot drop during walking.

      Some study for the patients after the onset of stroke (over several months) are reported that a case of the efficacy by the treatment using the FES, and another case of using FES indicated the equal efficacy and the higher QOL compared to using ankle-foot orthosis(AFO).

      However, these are clinical research results overseas and there are not so many studies targeting only for convalescent stroke patients.

      FES which recover the lost function by paralysis using electrical stimulation is recommended as convalescent rehabilitation by Japanese Guidelines for the Management of Stroke 2015 etc..

      The purpose of FES treatment is the electrical stimulation to peroneal nerve of patients with foot drop and equinus foot due to central nervous system damage and the objective efficacy is following:

      - To improve the walking by dorsiflexing the foot during swing phase

      - To prevention and suppression of disuse atrophy

      - To increase local blood flow

      - To re-educate muscle

      - To maintain or increase the range of joint motion

      20 locations

      Japan (20)
      • Matsuyama Rehabilitation Hospital
        recruiting
        Matsuyama-city, Ehime-prefecture, Japan, 791-1111
      • St.Mary's Hospital Healthcare Center
        recruiting
        Kurume-city, Fukuoka-prefecture, Japan, 830-0047
      • Yame Rehabilitation Hospital
        recruiting
        Yame-city, Fukuoka-prefecture, Japan, 834-0006
      • Tokachi Rehabilitation Center
        recruiting
        Obihiro-city, Hokkaido-prefecture, Japan, 080-0833
      • Sapporo Shiroishi Memorial Hospital
        recruiting
        Sapporo-city, Hokkaido-prefecture, Japan, 003-0026
      • Tokeidai Memorial Hospital
        recruiting
        Sapporo-city, Hokkaido-prefecture, Japan, 060-0031
      • Yoshida Hospital, Cerebrovascular Research Institute
        recruiting
        Kobe-city, Hyogo-prefecture, Japan, 652-0803
      • Kohshinkai Ogura Hospital
        recruiting
        Kanoya-city, Kagoshima-prefecture, Japan, 893-0023
      • Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
        recruiting
        Kirishima-city, Kagoshima-prefecture, Japan, 899-6603
      • Tarumi City Medical Center Tarumi Central Hospital
        recruiting
        Tarumi-city, Kagoshima-prefecture, Japan, 891-2124
      • Nichinan Municipal Chubu Hospital
        recruiting
        Nichinan-city, Miyazaki-prefecture, Japan, 889-3141
      • Nagasakikita Hospital
        recruiting
        Nishisonogi-gun, Nagasaki-prefecture, Japan, 851-2103
      • Ginowan Memorial Hospital
        recruiting
        Ginowan-city, Okinawa-prefecture, Japan, 901-2211
      • Chuzan Hospital
        recruiting
        Okinawa-city, Okinawa-prefecture, Japan, 904-2151
      • Okinawa Rehabilitation Center Hospital
        recruiting
        Okinawa-city, Okinawa-prefecture, Japan, 904-2173
      • Nanbu-Tokushukai Hospital
        recruiting
        Shimajiri-gun, Okinawa-prefecture, Japan, 901-0493
      • Kansai Rehabilitation Hospital
        recruiting
        Toyonaka-city, Osaka-prefecture, Japan, 560-0054
      • Saitama Misato Sogo Rehabilitation Hospital
        recruiting
        Misato-city, Saitama-prefecture, Japan, 341-0034
      • Seirei Hamamatsu City Rehabilitaion Hospital
        recruiting
        Hamamatsu-city, Shizuoka-prefecture, Japan, 433-8511
      • IMS Itabashi Rehabilitation Hospital
        recruiting
        Itabashi-ku, Tokyo, Japan, 174-0051
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      30 April, 2016
      Updated:
      12 June, 2017
      Participants:
      200
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