The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia
RALLY
2 other identifiers
interventional
202
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started May 2016
Longer than P75 for not_applicable stroke
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2019
CompletedJune 17, 2020
June 1, 2020
3 years
September 7, 2016
June 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8weeks
Secondary Outcomes (15)
maximum walking distance of 6 Minute Walk Test (with WA)
8weeks
maximum walking distance of 6 Minute Walk Test (with AFO)
8weeks
walking speed of 10 Meter Walk Test (bare feet)
8weeks
walking speed of 10 Meter Walk Test (with WA)
8weeks
walking speed of 10 Meter Walk Test (with AFO)
8weeks
- +10 more secondary outcomes
Study Arms (2)
WA
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \) Patients who agree to participate in this study and provide their informed consent
- \) Patients from 20 to 85 years old at the time of consent
- \) Patients of convalescent stoke (within 6 months of onset)
- \) Patients with a first episode of stroke, which type limited intracranial hemorrhage or ischemic stroke (excluding subarachnoid hemorrhage)
- \) Patients inpatients for the rehabilitation therapy
- \) Patients diagnosed 3 or 4 on Functional Ambulation Classification (FAC)
- \) Patients stable general condition(blood pressure, pulse, blood glucose level etc.)
- \) Patients with drop foot in walking
You may not qualify if:
- \) Patients due to severe heart disease
- \) Patients with previous gait disability, such as neurological disease
- \) Patients with previous orthopedic disease, such as knee osteoarthritis
- \) Patients with severe hepatic or renal dysfunction
- \) Patients with severe sensory disturbance or severe ataxia or severe higher brain dysfunction
- \) 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)
- \) Patients with severe skin disease
- \) Patients with any dose adjustment of antispasticity drugs (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) within 1month
- \) Patients whose impairment severities changed during the study period
- \) Patients taking the botulinum toxin formulation injection or the nerve block injection with phenol within 6months
- \) Patients with any lower limb treatment using FES or the robot suit within 1month
- \) Patients diagnosed not to use during the the WA trial operation period
- \) Patients who do not complete the WA trial operation for 7 days
- \) Patients joining any other clinical trials or studies with intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Shinyachiyo Hospital
Yachiyo, Chiba, 276-0015, Japan
Matsuyama Rehabilitation Hospital
Matsuyama, Ehime, 791-1111, Japan
St.Mary's Hospital Healthcare Center
Kurume, Fukuoka, 830-0047, Japan
Yame Rehabilitation Hospital
Yame, Fukuoka, 834-0006, Japan
Hokusei Memorial Hospital
Kitami, Hokkaido-prefecture, 090-0837, Japan
Ohkawara Neurosurgical Hospital
Muroran, Hokkaido-prefecture, 050-0082, Japan
Tokachi Rehabilitation Center
Obihiro, Hokkaido-prefecture, 080-0833, Japan
Sapporo Shiroishi Memorial Hospital
Sapporo, Hokkaido-prefecture, 003-0026, Japan
Sapporo Keijinkai Rehabilitation Hospital
Sapporo, Hokkaido-prefecture, 060-0010, Japan
Tokeidai Memorial Hospital
Sapporo, Hokkaido-prefecture, 060-0031, Japan
Yoshida Hospital, Cerebrovascular Research Institute
Kobe, Hyōgo, 652-0803, Japan
Kajikionsen Hospital
Aira, Kagoshima-ken, 899-5241, Japan
Acras Central Hospital
Kagoshima, Kagoshima-ken, 890-0031, Japan
Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
Kagoshima, Kagoshima-ken, 890-8520, Japan
Kohshinkai Ogura Hospital
Kanoya, Kagoshima-ken, 893-0023, Japan
Tarumi City Medical Center Tarumi Central Hospital
Tarumizu, Kagoshima-ken, 891-2124, Japan
Sakura Jyuji Hospital
Kumamoto, Kumamoto, 861-4173, Japan
Kumamoto Takumadai Rehabilitation Hospital
Kumamoto, Kumamoto, 862-0924, Japan
Fujimotokanmachi Hospital
Miyakonojō, Miyazaki, 885-0072, Japan
Junwakai Memorial Hospital
Miyazaki, Miyazaki, 880-2112, Japan
Nichinan Municipal Chubu Hospital
Nichinan, Miyazaki, 889-3141, Japan
Yohkoh Rehabilitation Hospital
Sasebo, Nagasaki, 857-0022, Japan
Nagasakikita Hospital
Togitsu-cho, Nishisonogi-gun, Nagasaki, 851-2103, Japan
Chuzan Hospital
Okinawa, Okinawa, 904-2151, Japan
Okinawa Rehabilitation Center Hospital
Okinawa, Okinawa, 904-2173, Japan
Nanbu-Tokushukai Hospital
Shimajiri-gun, Okinawa, 901-0493, Japan
Kansai Rehabilitation Hospital
Toyonaka, Osaka, 560-0054, Japan
Saitama Misato Sogo Rehabilitation Hospital
Misato, Saitama, Saitama, 341-0034, Japan
Seirei Hamamatsu City Rehabilitaion Hospital
Hamamatsu, Shizuoka, 433-8511, Japan
Hakujikai Memorial Hospital
Adachi-ku, Tokyo, 123-0864, Japan
IMS Itabashi Rehabilitation Hospital
Itabashi-ku, Tokyo, 174-0051, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shuji Matsumoto, MD, Ph.D
Nippon Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
September 13, 2016
Study Start
May 1, 2016
Primary Completion
April 24, 2019
Study Completion
November 29, 2019
Last Updated
June 17, 2020
Record last verified: 2020-06