Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia (RALLY)

16. června 2020 aktualizováno: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Aktuální)

202

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Japonsko
    • Chiba-prefecture
      • Yachiyo-city, Chiba-prefecture, Japonsko, 276-0015
        • Shinyachiyo Hospital
    • Ehime-prefecture
      • Matsuyama-city, Ehime-prefecture, Japonsko, 791-1111
        • Matsuyama Rehabilitation Hospital
    • Fukuoka-prefecture
      • Kurume-city, Fukuoka-prefecture, Japonsko, 830-0047
        • St.Mary's Hospital Healthcare Center
      • Yame-city, Fukuoka-prefecture, Japonsko, 834-0006
        • Yame Rehabilitation Hospital
    • Hokkaido-prefecture
      • Kitami-city, Hokkaido-prefecture, Japonsko, 090-0837
        • Hokusei Memorial Hospital
      • Muroran-city, Hokkaido-prefecture, Japonsko, 050-0082
        • Ohkawara Neurosurgical Hospital
      • Obihiro-city, Hokkaido-prefecture, Japonsko, 080-0833
        • Tokachi Rehabilitation Center
      • Sapporo-city, Hokkaido-prefecture, Japonsko, 003-0026
        • Sapporo Shiroishi Memorial Hospital
      • Sapporo-city, Hokkaido-prefecture, Japonsko, 060-0031
        • Tokeidai Memorial Hospital
      • Sapporo-city, Hokkaido-prefecture, Japonsko, 060-0010
        • Sapporo Keijinkai Rehabilitation Hospital
    • Hyogo-prefecture
      • Kobe-city, Hyogo-prefecture, Japonsko, 652-0803
        • Yoshida Hospital, Cerebrovascular Research Institute
    • Kagoshima-prefecture
      • Aira-city, Kagoshima-prefecture, Japonsko, 899-5241
        • Kajikionsen Hospital
      • Kagoshima-city, Kagoshima-prefecture, Japonsko, 890-0031
        • Acras Central Hospital
      • Kagoshima-city, Kagoshima-prefecture, Japonsko, 890-8520
        • Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
      • Kanoya-city, Kagoshima-prefecture, Japonsko, 893-0023
        • Kohshinkai Ogura Hospital
      • Tarumi-city, Kagoshima-prefecture, Japonsko, 891-2124
        • Tarumi City Medical Center Tarumi Central Hospital
    • Kumamoto-prefecture
      • Kumamoto-city, Kumamoto-prefecture, Japonsko, 861-4173
        • Sakura Jyuji Hospital
      • Kumamoto-city, Kumamoto-prefecture, Japonsko, 862-0924
        • Kumamoto Takumadai Rehabilitation Hospital
    • Miyazaki-prefecture
      • Miyakonojo-city, Miyazaki-prefecture, Japonsko, 885-0072
        • Fujimotokanmachi Hospital
      • Miyazaki-city, Miyazaki-prefecture, Japonsko, 880-2112
        • Junwakai Memorial Hospital
      • Nichinan-city, Miyazaki-prefecture, Japonsko, 889-3141
        • Nichinan Municipal Chubu Hospital
    • Nagasaki-prefecture
      • Sasebo-city, Nagasaki-prefecture, Japonsko, 857-0022
        • Yohkoh Rehabilitation Hospital
      • Togitsu-cho, Nishisonogi-gun, Nagasaki-prefecture, Japonsko, 851-2103
        • Nagasakikita Hospital
    • Okinawa-prefecture
      • Okinawa-city, Okinawa-prefecture, Japonsko, 904-2151
        • Chuzan Hospital
      • Okinawa-city, Okinawa-prefecture, Japonsko, 904-2173
        • Okinawa Rehabilitation Center Hospital
      • Shimajiri-gun, Okinawa-prefecture, Japonsko, 901-0493
        • Nanbu-Tokushukai Hospital
    • Osaka-prefecture
      • Toyonaka-city, Osaka-prefecture, Japonsko, 560-0054
        • Kansai Rehabilitation Hospital
    • Saitama-prefecture
      • Misato-city, Saitama-prefecture, Japonsko, 341-0034
        • Saitama Misato Sogo Rehabilitation Hospital
    • Shizuoka-prefecture
      • Hamamatsu-city, Shizuoka-prefecture, Japonsko, 433-8511
        • Seirei Hamamatsu City Rehabilitaion Hospital
    • Tokyo
      • Adachi-ku, Tokyo, Japonsko, 123-0864
        • Hakujikai Memorial Hospital
      • Itabashi-ku, Tokyo, Japonsko, 174-0051
        • IMS Itabashi Rehabilitation Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Řízení
Jiný: Control
Conventional rehabilitation therapy and gait training without WA.
Experimentální: WA
Přístroj: WA group
Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
maximum walking distance of 6 Minute Walk Test (bare feet)
Časové okno: 8weeks
Measuring maximum walking distance of 6 Minute Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting for all patients.
8weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
maximum walking distance of 6 Minute Walk Test (with WA)
Časové okno: 8weeks

Measuring maximum walking distance of 6 Minute Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values.

Targeting only for WA group.
8weeks
maximum walking distance of 6 Minute Walk Test (with AFO)
Časové okno: 8weeks

Measuring maximum walking distance of 6 Minute Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values.

Targeting only for patients using AFO before starting this study.
8weeks
walking speed of 10 Meter Walk Test (bare feet)
Časové okno: 8weeks
Measuring maximum walking speed of 10 Meter Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting for all patients.
8weeks
walking speed of 10 Meter Walk Test (with WA)
Časové okno: 8weeks
Measuring maximum walking speed of 10 Meter Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting only for WA group.
8weeks
walking speed of 10 Meter Walk Test (with AFO)
Časové okno: 8weeks
Measuring maximum walking speed of 10 Meter Walk Test at baseline and after 8-weeks intervention. Calculating difference of those measured values. Targeting only for patients using AFO before starting this study.
8weeks
Fugl-Meyer assessment (FMA)
Časové okno: 8weeks
Calculating difference of the total score of lower extremity subscale of the Fugl-Meyer Assessment (perfect score: 34 points) at baseline and after 8-weeks intervention.
8weeks
modified Ashworth scale (MAS)
Časové okno: 8weeks
Calculating difference of the muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) at baseline and after 8-weeks intervention.
8weeks
range of motion
Časové okno: 8weeks
Calculating difference of the angle of the ankle succumbed back (5 ° increments) at baseline and after 8-weeks intervention.
8weeks
Timed up and go test (bere feet)
Časové okno: 8weeks

Measuring the time that patients take to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down .

Calculating difference of those measured values between at baseline and after 8-weeks intervention. Targeting for all patients.
8weeks
Timed up and go test (with AFO)
Časové okno: 8weeks

Measuring the time that patients take to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down .

Calculating difference of those measured values between at baseline and after 8-weeks intervention. Targeting only for patients using AFO before starting this study.
8weeks
Timed up and go test (with WA)
Časové okno: 8weeks

Measuring the time that patients take to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down .

Calculating difference of those measured values between at baseline and after 8-weeks intervention. Targeting only for WA group.
8weeks
Stroke Impact Scale (SIS)
Časové okno: 8weeks
An evaluation of summation score of the total score and physical domain (sixth domain) score. Calculating difference of those measured values between at baseline and after 8-weeks intervention.
8weeks
Patient reported outcome measure (PRO)
Časové okno: 8weeks
Evaluation gait analysis using visual analogue scale(VAS scale) by Patient's own. Calculating the difference of these VAS scale between at baseline and after 8-weeks intervention.
8weeks
gait analysis by medical staff
Časové okno: 8weeks
Evaluation using total score of gait analysis by medical staff (-48~48).Calculating difference of these score between at baseline and after 8-weeks intervention.
8weeks
Adverse event assessment
Časové okno: 8weeks

A frequency counting of the adverse events. LLT code will be assigned to the reported adverse event using the MedDRA dictionary.

The origin date of the term until adverse events define the start date of the treatment program(0 week).

Also doing a frequency counting of adverse events observed during the the WA trial operation period, but not included in the safety evaluation of the treatment program.
8weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Spolupracovníci

Kagoshima University
Nippon Medical School

Vyšetřovatelé

  • Studijní židle: Shuji Matsumoto, MD, Ph.D, Nippon Medical School

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. května 2016

Primární dokončení (Aktuální)

24. dubna 2019

Dokončení studie (Aktuální)

29. listopadu 2019

Termíny zápisu do studia

První předloženo

7. září 2016

První předloženo, které splnilo kritéria kontroly kvality

7. září 2016

První zveřejněno (Odhad)

13. září 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. června 2020

Naposledy ověřeno

1. června 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TRIORTHO1524
  • UMIN-CTR (Jiný identifikátor: UMIN000020604)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na WA group

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Kosovo

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit