Back to resultsThe Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia (RALLY)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
WA group
Control
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)
Eligibility 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
Sites / Locations
- Shinyachiyo Hospital
- Matsuyama Rehabilitation Hospital
- St.Mary's Hospital Healthcare Center
- Yame Rehabilitation Hospital
- Hokusei Memorial Hospital
- Ohkawara Neurosurgical Hospital
- Tokachi Rehabilitation Center
- Sapporo Shiroishi Memorial Hospital
- Sapporo Keijinkai Rehabilitation Hospital
- Tokeidai Memorial Hospital
- Yoshida Hospital, Cerebrovascular Research Institute
- Kajikionsen Hospital
- Acras Central Hospital
- Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
- Kohshinkai Ogura Hospital
- Tarumi City Medical Center Tarumi Central Hospital
- Sakura Jyuji Hospital
- Kumamoto Takumadai Rehabilitation Hospital
- Fujimotokanmachi Hospital
- Junwakai Memorial Hospital
- Nichinan Municipal Chubu Hospital
- Yohkoh Rehabilitation Hospital
- Nagasakikita Hospital
- Chuzan Hospital
- Okinawa Rehabilitation Center Hospital
- Nanbu-Tokushukai Hospital
- Kansai Rehabilitation Hospital
- Saitama Misato Sogo Rehabilitation Hospital
- Seirei Hamamatsu City Rehabilitaion Hospital
- Hakujikai Memorial Hospital
- IMS Itabashi Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WA
Control
Arm Description
Outcomes
Primary Outcome Measures
maximum walking distance of 6 Minute Walk Test (bare feet)
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
maximum walking distance of 6 Minute Walk Test (with WA)
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.
maximum walking distance of 6 Minute Walk Test (with AFO)
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.
walking speed of 10 Meter Walk Test (bare feet)
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.
walking speed of 10 Meter Walk Test (with WA)
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.
walking speed of 10 Meter Walk Test (with AFO)
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.
Fugl-Meyer assessment (FMA)
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.
modified Ashworth scale (MAS)
Calculating difference of the muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) at baseline and after 8-weeks intervention.
range of motion
Calculating difference of the angle of the ankle succumbed back (5 ° increments) at baseline and after 8-weeks intervention.
Timed up and go test (bere feet)
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.
Timed up and go test (with AFO)
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.
Timed up and go test (with WA)
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.
Stroke Impact Scale (SIS)
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.
Patient reported outcome measure (PRO)
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.
gait analysis by medical staff
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.
Adverse event assessment
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.
Full Information
NCT ID
NCT02898168
First Posted
September 7, 2016
Last Updated
June 16, 2020
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Nippon Medical School, Kagoshima University
1. Study Identification
Unique Protocol Identification Number
NCT02898168
Brief Title
The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia
Acronym
RALLY
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Nippon Medical School, Kagoshima University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WA
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
WA group
Intervention Description
Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Conventional rehabilitation therapy and gait training without WA.
Primary Outcome Measure Information:
Title
maximum walking distance of 6 Minute Walk Test (bare feet)
Description
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.
Time Frame
8weeks
Secondary Outcome Measure Information:
Title
maximum walking distance of 6 Minute Walk Test (with WA)
Description
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.
Time Frame
8weeks
Title
maximum walking distance of 6 Minute Walk Test (with AFO)
Description
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.
Time Frame
8weeks
Title
walking speed of 10 Meter Walk Test (bare feet)
Description
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.
Time Frame
8weeks
Title
walking speed of 10 Meter Walk Test (with WA)
Description
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.
Time Frame
8weeks
Title
walking speed of 10 Meter Walk Test (with AFO)
Description
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.
Time Frame
8weeks
Title
Fugl-Meyer assessment (FMA)
Description
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.
Time Frame
8weeks
Title
modified Ashworth scale (MAS)
Description
Calculating difference of the muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) at baseline and after 8-weeks intervention.
Time Frame
8weeks
Title
range of motion
Description
Calculating difference of the angle of the ankle succumbed back (5 ° increments) at baseline and after 8-weeks intervention.
Time Frame
8weeks
Title
Timed up and go test (bere feet)
Description
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.
Time Frame
8weeks
Title
Timed up and go test (with AFO)
Description
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.
Time Frame
8weeks
Title
Timed up and go test (with WA)
Description
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.
Time Frame
8weeks
Title
Stroke Impact Scale (SIS)
Description
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.
Time Frame
8weeks
Title
Patient reported outcome measure (PRO)
Description
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.
Time Frame
8weeks
Title
gait analysis by medical staff
Description
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.
Time Frame
8weeks
Title
Adverse event assessment
Description
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.
Time Frame
8weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuji Matsumoto, MD, Ph.D
Organizational Affiliation
Nippon Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Shinyachiyo Hospital
City
Yachiyo-city
State/Province
Chiba-prefecture
ZIP/Postal Code
276-0015
Country
Japan
Facility Name
Matsuyama Rehabilitation Hospital
City
Matsuyama-city
State/Province
Ehime-prefecture
ZIP/Postal Code
791-1111
Country
Japan
Facility Name
St.Mary's Hospital Healthcare Center
City
Kurume-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
830-0047
Country
Japan
Facility Name
Yame Rehabilitation Hospital
City
Yame-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
834-0006
Country
Japan
Facility Name
Hokusei Memorial Hospital
City
Kitami-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
090-0837
Country
Japan
Facility Name
Ohkawara Neurosurgical Hospital
City
Muroran-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
050-0082
Country
Japan
Facility Name
Tokachi Rehabilitation Center
City
Obihiro-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
080-0833
Country
Japan
Facility Name
Sapporo Shiroishi Memorial Hospital
City
Sapporo-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
003-0026
Country
Japan
Facility Name
Sapporo Keijinkai Rehabilitation Hospital
City
Sapporo-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
060-0010
Country
Japan
Facility Name
Tokeidai Memorial Hospital
City
Sapporo-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
060-0031
Country
Japan
Facility Name
Yoshida Hospital, Cerebrovascular Research Institute
City
Kobe-city
State/Province
Hyogo-prefecture
ZIP/Postal Code
652-0803
Country
Japan
Facility Name
Kajikionsen Hospital
City
Aira-city
State/Province
Kagoshima-prefecture
ZIP/Postal Code
899-5241
Country
Japan
Facility Name
Acras Central Hospital
City
Kagoshima-city
State/Province
Kagoshima-prefecture
ZIP/Postal Code
890-0031
Country
Japan
Facility Name
Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
City
Kagoshima-city
State/Province
Kagoshima-prefecture
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kohshinkai Ogura Hospital
City
Kanoya-city
State/Province
Kagoshima-prefecture
ZIP/Postal Code
893-0023
Country
Japan
Facility Name
Tarumi City Medical Center Tarumi Central Hospital
City
Tarumi-city
State/Province
Kagoshima-prefecture
ZIP/Postal Code
891-2124
Country
Japan
Facility Name
Sakura Jyuji Hospital
City
Kumamoto-city
State/Province
Kumamoto-prefecture
ZIP/Postal Code
861-4173
Country
Japan
Facility Name
Kumamoto Takumadai Rehabilitation Hospital
City
Kumamoto-city
State/Province
Kumamoto-prefecture
ZIP/Postal Code
862-0924
Country
Japan
Facility Name
Fujimotokanmachi Hospital
City
Miyakonojo-city
State/Province
Miyazaki-prefecture
ZIP/Postal Code
885-0072
Country
Japan
Facility Name
Junwakai Memorial Hospital
City
Miyazaki-city
State/Province
Miyazaki-prefecture
ZIP/Postal Code
880-2112
Country
Japan
Facility Name
Nichinan Municipal Chubu Hospital
City
Nichinan-city
State/Province
Miyazaki-prefecture
ZIP/Postal Code
889-3141
Country
Japan
Facility Name
Yohkoh Rehabilitation Hospital
City
Sasebo-city
State/Province
Nagasaki-prefecture
ZIP/Postal Code
857-0022
Country
Japan
Facility Name
Nagasakikita Hospital
City
Togitsu-cho, Nishisonogi-gun
State/Province
Nagasaki-prefecture
ZIP/Postal Code
851-2103
Country
Japan
Facility Name
Chuzan Hospital
City
Okinawa-city
State/Province
Okinawa-prefecture
ZIP/Postal Code
904-2151
Country
Japan
Facility Name
Okinawa Rehabilitation Center Hospital
City
Okinawa-city
State/Province
Okinawa-prefecture
ZIP/Postal Code
904-2173
Country
Japan
Facility Name
Nanbu-Tokushukai Hospital
City
Shimajiri-gun
State/Province
Okinawa-prefecture
ZIP/Postal Code
901-0493
Country
Japan
Facility Name
Kansai Rehabilitation Hospital
City
Toyonaka-city
State/Province
Osaka-prefecture
ZIP/Postal Code
560-0054
Country
Japan
Facility Name
Saitama Misato Sogo Rehabilitation Hospital
City
Misato-city
State/Province
Saitama-prefecture
ZIP/Postal Code
341-0034
Country
Japan
Facility Name
Seirei Hamamatsu City Rehabilitaion Hospital
City
Hamamatsu-city
State/Province
Shizuoka-prefecture
ZIP/Postal Code
433-8511
Country
Japan
Facility Name
Hakujikai Memorial Hospital
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
123-0864
Country
Japan
Facility Name
IMS Itabashi Rehabilitation Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
174-0051
Country
Japan
12. IPD Sharing Statement
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The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia
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