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

16 giugno 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Effettivo)

202

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Controllo
Altro: Control
Conventional rehabilitation therapy and gait training without WA.
Sperimentale: WA
Dispositivo: WA group
Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
maximum walking distance of 6 Minute Walk Test (bare feet)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
maximum walking distance of 6 Minute Walk Test (with WA)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Collaboratori

Kagoshima University
Nippon Medical School

Investigatori

  • Cattedra di studio: Shuji Matsumoto, MD, Ph.D, Nippon Medical School

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2016

Completamento primario (Effettivo)

24 aprile 2019

Completamento dello studio (Effettivo)

29 novembre 2019

Date di iscrizione allo studio

Primo inviato

7 settembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

7 settembre 2016

Primo Inserito (Stima)

13 settembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2020

Ultimo verificato

1 giugno 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TRIORTHO1524
  • UMIN-CTR (Altro identificatore: UMIN000020604)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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