StrokeRALLYNCT02898168
The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia
A study testing WA group in people with Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 31 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- WA group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 31 sitesJapan
- Study dates
- May 2016to 29 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Japan31 sites
Hakujikai Memorial Hospital
Adachi-ku, Tokyo, 123-0864
Kajikionsen Hospital
Aira, Kagoshima-ken, 899-5241
Seirei Hamamatsu City Rehabilitaion Hospital
Hamamatsu, Shizuoka, 433-8511
Acras Central Hospital
Kagoshima, Kagoshima-ken, 890-0031
Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
Kagoshima, Kagoshima-ken, 890-8520
Kohshinkai Ogura Hospital
Kanoya, Kagoshima-ken, 893-0023
Hokusei Memorial Hospital
Kitami, Hokkaido-prefecture, 090-0837
Yoshida Hospital, Cerebrovascular Research Institute
Kobe, Hyōgo, 652-0803
Sakura Jyuji Hospital
Kumamoto, Kumamoto, 861-4173
Kumamoto Takumadai Rehabilitation Hospital
Kumamoto, Kumamoto, 862-0924
St.Mary's Hospital Healthcare Center
Kurume, Fukuoka, 830-0047
Matsuyama Rehabilitation Hospital
Matsuyama, Ehime, 791-1111
Saitama Misato Sogo Rehabilitation Hospital
Misato, Saitama, Saitama, 341-0034
Fujimotokanmachi Hospital
Miyakonojō, Miyazaki, 885-0072
Junwakai Memorial Hospital
Miyazaki, Miyazaki, 880-2112
Ohkawara Neurosurgical Hospital
Muroran, Hokkaido-prefecture, 050-0082
Nichinan Municipal Chubu Hospital
Nichinan, Miyazaki, 889-3141
Tokachi Rehabilitation Center
Obihiro, Hokkaido-prefecture, 080-0833
Chuzan Hospital
Okinawa, Okinawa, 904-2151
Okinawa Rehabilitation Center Hospital
Okinawa, Okinawa, 904-2173
Sapporo Shiroishi Memorial Hospital
Sapporo, Hokkaido-prefecture, 003-0026
Sapporo Keijinkai Rehabilitation Hospital
Sapporo, Hokkaido-prefecture, 060-0010
Tokeidai Memorial Hospital
Sapporo, Hokkaido-prefecture, 060-0031
Yohkoh Rehabilitation Hospital
Sasebo, Nagasaki, 857-0022
Nanbu-Tokushukai Hospital
Shimajiri-gun, Okinawa, 901-0493
IMS Itabashi Rehabilitation Hospital
tabashi City, Tokyo, 174-0051
Tarumi City Medical Center Tarumi Central Hospital
Tarumizu, Kagoshima-ken, 891-2124
Nagasakikita Hospital
Togitsu-cho, Nishisonogi-gun, Nagasaki, 851-2103
Kansai Rehabilitation Hospital
Toyonaka, Osaka, 560-0054
Shinyachiyo Hospital
Yachiyo, Chiba, 276-0015
Yame Rehabilitation Hospital
Yame, Fukuoka, 834-0006
About this study
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
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.
Read the 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
- Conditions
- Stroke
- Being tested
- WA group, Control
- Keywords
- stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WA groupDevice
Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.
ControlOther
Conventional rehabilitation therapy and gait training without WA.
| Study group | Role | What they receive |
|---|---|---|
| WA | Experimental | Not described Receives: Device: WA group |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8weeks
Secondary outcomes (15)
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
range of motion
Calculating difference of the angle of the ankle succumbed back (5 ° increments) at baseline and after 8-weeks intervention.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
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.
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startMay 2016
- Primary completion24 Apr 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Nippon Medical School, Kagoshima University
- Responsible party
- Sponsor
- Investigators
- Shuji Matsumoto, MD, Ph.D, Study chair, Nippon Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898168
- Sponsor's protocol ID
- TRIORTHO1524
- Other IDs
- UMIN-CTR
- Acronym
- RALLY
- Status last verified
- Jun 2020
- First submitted
- 7 Sep 2016
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02898168
- Acronym / sponsor ID
- RALLY / TRIORTHO1524
- Conditions
- Stroke
- Keywords
- stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Nippon Medical School, Kagoshima University
- Study start
- May 2016 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WA | Experimental | Device: WA group |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WA groupConventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks. | Device | WA |
| ControlConventional rehabilitation therapy and gait training without WA. | Other | Control |
Primary outcome
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.
15 secondary outcomes
maximum walking distance of 6 Minute Walk Test (with WA)
Time frame: 8weeks
maximum walking distance of 6 Minute Walk Test (with AFO)
Time frame: 8weeks
walking speed of 10 Meter Walk Test (bare feet)
Time frame: 8weeks
walking speed of 10 Meter Walk Test (with WA)
Time frame: 8weeks
walking speed of 10 Meter Walk Test (with AFO)
Time frame: 8weeks
Fugl-Meyer assessment (FMA)
Time frame: 8weeks
modified Ashworth scale (MAS)
Time frame: 8weeks
range of motion
Time frame: 8weeks
Timed up and go test (bere feet)
Time frame: 8weeks
Timed up and go test (with AFO)
Time frame: 8weeks
Timed up and go test (with WA)
Time frame: 8weeks
Stroke Impact Scale (SIS)
Time frame: 8weeks
Patient reported outcome measure (PRO)
Time frame: 8weeks
gait analysis by medical staff
Time frame: 8weeks
Adverse event assessment
Time frame: 8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuji Matsumoto, MD, Ph.D study chair
Nippon Medical School
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WA group in people with Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 31 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum walking distance of 6 Minute Walk Test (bare feet) (time frame: 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.