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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898168
• Other study ID #: TRIORTHO1524
• Secondary ID: UMIN-CTR
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: November 29, 2019

Study information

• Verified date: June 2020
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: November 29, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

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

Other:
• Control
Conventional rehabilitation therapy and gait training without WA.

Locations

Country	Name	City	State
Japan	Hakujikai Memorial Hospital	Adachi-ku	Tokyo
Japan	Kajikionsen Hospital	Aira-city	Kagoshima-prefecture
Japan	Seirei Hamamatsu City Rehabilitaion Hospital	Hamamatsu-city	Shizuoka-prefecture
Japan	IMS Itabashi Rehabilitation Hospital	Itabashi-ku	Tokyo
Japan	Acras Central Hospital	Kagoshima-city	Kagoshima-prefecture
Japan	Department of Rehabilitation and Physical Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University	Kagoshima-city	Kagoshima-prefecture
Japan	Kohshinkai Ogura Hospital	Kanoya-city	Kagoshima-prefecture
Japan	Hokusei Memorial Hospital	Kitami-city	Hokkaido-prefecture
Japan	Yoshida Hospital, Cerebrovascular Research Institute	Kobe-city	Hyogo-prefecture
Japan	Kumamoto Takumadai Rehabilitation Hospital	Kumamoto-city	Kumamoto-prefecture
Japan	Sakura Jyuji Hospital	Kumamoto-city	Kumamoto-prefecture
Japan	St.Mary's Hospital Healthcare Center	Kurume-city	Fukuoka-prefecture
Japan	Matsuyama Rehabilitation Hospital	Matsuyama-city	Ehime-prefecture
Japan	Saitama Misato Sogo Rehabilitation Hospital	Misato-city	Saitama-prefecture
Japan	Fujimotokanmachi Hospital	Miyakonojo-city	Miyazaki-prefecture
Japan	Junwakai Memorial Hospital	Miyazaki-city	Miyazaki-prefecture
Japan	Ohkawara Neurosurgical Hospital	Muroran-city	Hokkaido-prefecture
Japan	Nichinan Municipal Chubu Hospital	Nichinan-city	Miyazaki-prefecture
Japan	Tokachi Rehabilitation Center	Obihiro-city	Hokkaido-prefecture
Japan	Chuzan Hospital	Okinawa-city	Okinawa-prefecture
Japan	Okinawa Rehabilitation Center Hospital	Okinawa-city	Okinawa-prefecture
Japan	Sapporo Keijinkai Rehabilitation Hospital	Sapporo-city	Hokkaido-prefecture
Japan	Sapporo Shiroishi Memorial Hospital	Sapporo-city	Hokkaido-prefecture
Japan	Tokeidai Memorial Hospital	Sapporo-city	Hokkaido-prefecture
Japan	Yohkoh Rehabilitation Hospital	Sasebo-city	Nagasaki-prefecture
Japan	Nanbu-Tokushukai Hospital	Shimajiri-gun	Okinawa-prefecture
Japan	Tarumi City Medical Center Tarumi Central Hospital	Tarumi-city	Kagoshima-prefecture
Japan	Nagasakikita Hospital	Togitsu-cho, Nishisonogi-gun	Nagasaki-prefecture
Japan	Kansai Rehabilitation Hospital	Toyonaka-city	Osaka-prefecture
Japan	Shinyachiyo Hospital	Yachiyo-city	Chiba-prefecture
Japan	Yame Rehabilitation Hospital	Yame-city	Fukuoka-prefecture

Sponsors (3)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Kagoshima University, Nippon Medical School

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	range of motion	Calculating difference of the angle of the ankle succumbed back (5 ° increments) at baseline and after 8-weeks intervention.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks
Secondary	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.	8weeks