The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia

NCT ID: NCT02898168

Last Updated: 2020-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-11-29

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

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WA

Group Type: EXPERIMENTAL

WA group

Intervention Type: DEVICE

Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.

Control

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Conventional rehabilitation therapy and gait training without WA.

Interventions

WA group

Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.

Intervention Type: DEVICE

Control

Conventional rehabilitation therapy and gait training without WA.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nippon Medical School

OTHER

Sponsor Role: collaborator

Kagoshima University

OTHER

Sponsor Role: collaborator

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuji Matsumoto, MD, Ph.D

Role: STUDY_CHAIR

Nippon Medical School

Locations

Shinyachiyo Hospital

Yachiyo, Chiba, Japan

Matsuyama Rehabilitation Hospital

Matsuyama, Ehime, Japan

St.Mary's Hospital Healthcare Center

Kurume, Fukuoka, Japan

Yame Rehabilitation Hospital

Yame, Fukuoka, Japan

Hokusei Memorial Hospital

Kitami, Hokkaido-prefecture, Japan

Ohkawara Neurosurgical Hospital

Muroran, Hokkaido-prefecture, Japan

Tokachi Rehabilitation Center

Obihiro, Hokkaido-prefecture, Japan

Sapporo Shiroishi Memorial Hospital

Sapporo, Hokkaido-prefecture, Japan

Sapporo Keijinkai Rehabilitation Hospital

Sapporo, Hokkaido-prefecture, Japan

Tokeidai Memorial Hospital

Sapporo, Hokkaido-prefecture, Japan

Yoshida Hospital, Cerebrovascular Research Institute

Kobe, Hyōgo, Japan

Kajikionsen Hospital

Aira, Kagoshima-ken, Japan

Acras Central Hospital

Kagoshima, Kagoshima-ken, Japan

Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University

Kagoshima, Kagoshima-ken, Japan

Kohshinkai Ogura Hospital

Kanoya, Kagoshima-ken, Japan

Tarumi City Medical Center Tarumi Central Hospital

Tarumizu, Kagoshima-ken, Japan

Sakura Jyuji Hospital

Kumamoto, Kumamoto, Japan

Kumamoto Takumadai Rehabilitation Hospital

Kumamoto, Kumamoto, Japan

Fujimotokanmachi Hospital

Miyakonojō, Miyazaki, Japan

Junwakai Memorial Hospital

Miyazaki, Miyazaki, Japan

Nichinan Municipal Chubu Hospital

Nichinan, Miyazaki, Japan

Yohkoh Rehabilitation Hospital

Sasebo, Nagasaki, Japan

Nagasakikita Hospital

Togitsu-cho, Nishisonogi-gun, Nagasaki, Japan

Chuzan Hospital

Okinawa, Okinawa, Japan

Okinawa Rehabilitation Center Hospital

Okinawa, Okinawa, Japan

Nanbu-Tokushukai Hospital

Shimajiri-gun, Okinawa, Japan

Kansai Rehabilitation Hospital

Toyonaka, Osaka, Japan

Saitama Misato Sogo Rehabilitation Hospital

Misato, Saitama, Saitama, Japan

Seirei Hamamatsu City Rehabilitaion Hospital

Hamamatsu, Shizuoka, Japan

Hakujikai Memorial Hospital

Adachi-ku, Tokyo, Japan

IMS Itabashi Rehabilitation Hospital

Itabashi-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

UMIN-CTR

Identifier Type: OTHER

Identifier Source: secondary_id

TRIORTHO1524

Identifier Type: -

Identifier Source: org_study_id