Clinical trial NCT02898168: The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Rehabilitation
WalkAide (WA)
Functional Electrical Stimulation (FES)
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Nippon Medical School
name: Kagoshima University
First posted: 2016-09-13
Enrollment: 202
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: maximum walking distance of 6 Minute Walk Test (bare feet)
timeFrame: 8weeks
Secondary outcomes:
measure: maximum walking distance of 6 Minute Walk Test (with WA)
timeFrame: 8weeks
measure: maximum walking distance of 6 Minute Walk Test (with AFO)
timeFrame: 8weeks
measure: walking speed of 10 Meter Walk Test (bare feet)
timeFrame: 8weeks
measure: walking speed of 10 Meter Walk Test (with WA)
timeFrame: 8weeks
measure: walking speed of 10 Meter Walk Test (with AFO)
timeFrame: 8weeks
measure: Fugl-Meyer assessment (FMA)
timeFrame: 8weeks
measure: modified Ashworth scale (MAS)
timeFrame: 8weeks
measure: range of motion
timeFrame: 8weeks
measure: Timed up and go test (bere feet)
timeFrame: 8weeks
measure: Timed up and go test (with AFO)
timeFrame: 8weeks
measure: Timed up and go test (with WA)
timeFrame: 8weeks
measure: Stroke Impact Scale (SIS)
timeFrame: 8weeks
measure: Patient reported outcome measure (PRO)
timeFrame: 8weeks
measure: gait analysis by medical staff
timeFrame: 8weeks
measure: Adverse event assessment
timeFrame: 8weeks
Other outcomes:
Locations:
city: Yachiyo-city
country: Japan
facility: Shinyachiyo Hospital
state: Chiba-prefecture
city: Matsuyama-city
country: Japan
facility: Matsuyama Rehabilitation Hospital
state: Ehime-prefecture
city: Kurume-city
country: Japan
facility: St.Mary's Hospital Healthcare Center
state: Fukuoka-prefecture
city: Yame-city
country: Japan
facility: Yame Rehabilitation Hospital
state: Fukuoka-prefecture
city: Kitami-city
country: Japan
facility: Hokusei Memorial Hospital
state: Hokkaido-prefecture
city: Muroran-city
country: Japan
facility: Ohkawara Neurosurgical Hospital
state: Hokkaido-prefecture
city: Obihiro-city
country: Japan
facility: Tokachi Rehabilitation Center
state: Hokkaido-prefecture
city: Sapporo-city
country: Japan
facility: Sapporo Shiroishi Memorial Hospital
state: Hokkaido-prefecture
city: Sapporo-city
country: Japan
facility: Sapporo Keijinkai Rehabilitation Hospital
state: Hokkaido-prefecture
city: Sapporo-city
country: Japan
facility: Tokeidai Memorial Hospital
state: Hokkaido-prefecture
city: Kobe-city
country: Japan
facility: Yoshida Hospital, Cerebrovascular Research Institute
state: Hyogo-prefecture
city: Aira-city
country: Japan
facility: Kajikionsen Hospital
state: Kagoshima-prefecture
city: Kagoshima-city
country: Japan
facility: Acras Central Hospital
state: Kagoshima-prefecture
city: Kagoshima-city
country: Japan
facility: Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
state: Kagoshima-prefecture
city: Kanoya-city
country: Japan
facility: Kohshinkai Ogura Hospital
state: Kagoshima-prefecture
city: Tarumi-city
country: Japan
facility: Tarumi City Medical Center Tarumi Central Hospital
state: Kagoshima-prefecture
city: Kumamoto-city
country: Japan
facility: Sakura Jyuji Hospital
state: Kumamoto-prefecture
city: Kumamoto-city
country: Japan
facility: Kumamoto Takumadai Rehabilitation Hospital
state: Kumamoto-prefecture
city: Miyakonojo-city
country: Japan
facility: Fujimotokanmachi Hospital
state: Miyazaki-prefecture
city: Miyazaki-city
country: Japan
facility: Junwakai Memorial Hospital
state: Miyazaki-prefecture
city: Nichinan-city
country: Japan
facility: Nichinan Municipal Chubu Hospital
state: Miyazaki-prefecture
city: Sasebo-city
country: Japan
facility: Yohkoh Rehabilitation Hospital
state: Nagasaki-prefecture
city: Togitsu-cho, Nishisonogi-gun
country: Japan
facility: Nagasakikita Hospital
state: Nagasaki-prefecture
city: Okinawa-city
country: Japan
facility: Chuzan Hospital
state: Okinawa-prefecture
city: Okinawa-city
country: Japan
facility: Okinawa Rehabilitation Center Hospital
state: Okinawa-prefecture
city: Shimajiri-gun
country: Japan
facility: Nanbu-Tokushukai Hospital
state: Okinawa-prefecture
city: Toyonaka-city
country: Japan
facility: Kansai Rehabilitation Hospital
state: Osaka-prefecture
city: Misato-city
country: Japan
facility: Saitama Misato Sogo Rehabilitation Hospital
state: Saitama-prefecture
city: Hamamatsu-city
country: Japan
facility: Seirei Hamamatsu City Rehabilitaion Hospital
state: Shizuoka-prefecture
city: Adachi-ku
country: Japan
facility: Hakujikai Memorial Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: IMS Itabashi Rehabilitation Hospital
state: Tokyo
Study officials:
affiliation: Nippon Medical School
name: Shuji Matsumoto, MD, Ph.D
role: STUDY_CHAIR
References: