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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898168
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : June 17, 2020
Sponsor:
Collaborators:
Nippon Medical School
Kagoshima University
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Device: WA group Other: Control Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia A Randomized Controlled Study
Actual Study Start Date : May 2016
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : November 29, 2019

Arm Intervention/treatment
Experimental: WA Device: WA group
Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.

Active Comparator: Control Other: Control
Conventional rehabilitation therapy and gait training without WA.




Primary Outcome Measures :
  1. maximum walking distance of 6 Minute Walk Test (bare feet) [ Time Frame: 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.


Secondary Outcome Measures :
  1. maximum walking distance of 6 Minute Walk Test (with WA) [ Time Frame: 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.


  2. maximum walking distance of 6 Minute Walk Test (with AFO) [ Time Frame: 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.


  3. walking speed of 10 Meter Walk Test (bare feet) [ Time Frame: 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.

  4. walking speed of 10 Meter Walk Test (with WA) [ Time Frame: 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.

  5. walking speed of 10 Meter Walk Test (with AFO) [ Time Frame: 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.

  6. Fugl-Meyer assessment (FMA) [ Time Frame: 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.

  7. modified Ashworth scale (MAS) [ Time Frame: 8weeks ]
    Calculating difference of the muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) at baseline and after 8-weeks intervention.

  8. range of motion [ Time Frame: 8weeks ]
    Calculating difference of the angle of the ankle succumbed back (5 ° increments) at baseline and after 8-weeks intervention.

  9. Timed up and go test (bere feet) [ Time Frame: 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.


  10. Timed up and go test (with AFO) [ Time Frame: 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.


  11. Timed up and go test (with WA) [ Time Frame: 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.


  12. Stroke Impact Scale (SIS) [ Time Frame: 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.

  13. Patient reported outcome measure (PRO) [ Time Frame: 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.

  14. gait analysis by medical staff [ Time Frame: 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.

  15. Adverse event assessment [ Time Frame: 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.




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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898168


Locations
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Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Nippon Medical School
Kagoshima University
Investigators
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Study Chair: Shuji Matsumoto, MD, Ph.D Nippon Medical School
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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT02898168    
Other Study ID Numbers: TRIORTHO1524
UMIN-CTR ( Other Identifier: UMIN000020604 )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
stroke
Rehabilitation
WalkAide (WA)
Functional Electrical Stimulation (FES)
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms