Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients
- Conditions
- Stroke
- Interventions
- Device: gait training with WAOther: usual gait training
- Registration Number
- NCT02897752
- Lead Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Brief Summary
RATIONALE:
The previous study resulted that the gait training using Functional Electrical Stimulation (FES) improved the ankle joint function and the walking ability for the chronic stroke patients with foot drop.
In addition, the further exploratory study in multicenter obtained the result that the training with WA were especially good adaptation to the patients who have slight paralysis and can walk independently.
PURPOSE:
This multicenter prospective trial is studying to reveal whether the gait training with the WalkAide\[R\](WA) for chronic stroke patients who can walk independently is superior to gait training with a physical therapist.
- Detailed Description
OBJECTIVE:
To reveal whether gait training with the WA for chronic stroke patients who can walk independently (Functional Ambulation Classification \[FAC\] 5 or 6) is superior to gait training with a physical therapist.
OUTLINE:
This is a multicenter study. Patients continue gait training with WA or without WA for 4 weeks. The effect of rehabilitation is evaluated by 6 Minute Walk Test without device.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 1)First-ever hemiplegic patients 4 months after the stroke onset
- 2)Patients whose the lower extremity paralysis is estimated to be stage IV, V or VI according to the Brunnstrom stage
- 3)Patients whose spasticity of the plantar flexor muscle is estimated at 2 or less according to the Modified Ashworth Scale
- 4)Patients whose ankle dorsiflexion range of motion is 0 degree or more
- 5)Patients whose gait performance is estimated to be 5 or 6 according to the FAC
- 6)Patients who can understand the purpose and instructions of this study and complete the training
- 7)Patients who agree to participate in this study and provide their written informed consent
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1)Patients whose ankle dorsiflexion is not induced by the WA due to peripheral neuropathy
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2)Patients who are contraindicated for the WA (e.g., patients with a metallic implant or implantable medical electrical equipment such as a cardiac pacemaker, and patients with a previous or suspected history of seizure)
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3)Patients who underwent Botox treatment in the lower extremities within 3 months of this study registry
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4)Patients who have nervous system (excluding stroke), cardio-respiratory system, or musculoskeletal system disorders, which may affect gait and training
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5)Patients who had fallen down within a week prior to the registry and are regarded to be at a high risk of falling down by an attending physician
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6)Patients whose impairment severities changed between the prior and initial assessments
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Definition of an alteration
- Brunnstrom stage for the lower extremity: Confirm whether the stages of the prior and initial assessments are the same value. If these stages are different, this is considered to be an alteration, and the patient with this alteration should be excluded from the study.
- Lower extremity subscale of the Fugl-Meyer Assessment: Confirm whether the change in the score between the prior and initial assessments is 5 or less. If the change is 6 or more, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study.
- Functional Ambulation Classification: Confirm whether the categories of the prior and initial assessments are the same value. If these categories are different, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study.
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- Patients who are regarded to be ineligible for this study by the principal investigator or co-investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WalkAide gait training with WA - Usual gait Training usual gait training -
- Primary Outcome Measures
Name Time Method 6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort) 4weeks An evaluation of the effectiveness of WA-assisted gait training using the 6MWT without any device before and after each intervention in the WA-assisted training group (WA group) and usual training group (UT group).
- Secondary Outcome Measures
Name Time Method Lower extremity subscale of the Fugl-Meyer Assessment 4weeks An evaluation of the severity of lower extremity using the total score of lower extremity subscale of the Fugl-Meyer Assessment (perfect score: 34 points).
Muscle strength of the ankle dorsiflexor muscle 4weeks An evaluation of the value(Newton/kg) using the ankle back flexor force of three times measured on average, divided by the weight value.
Ankle dorsiflexion range of motion 4weeks An evaluation of range of motion (ROM) as the angle of the ankle succumbed back from the knee joint flexed position in the chair seat position (5 ° increments).
Modified Ashworth Scale for the plantar flexor muscle 4weeks An evaluation of Modified Ashworth Scale (MAS) as the degree of muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) .
The extent of MAS number indicating the muscle tone degree.10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed). 4weeks An evaluation of the effectiveness of WA-assisted gait training using the 10MWT without any device before and after each intervention in the WA and UT groups.
Stroke Impact Scale 4weeks An evaluation of summation score of the total score and physical domain (sixth domain) score.
Adverse event assessment 4weeks 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 protocol treatment.
Trial Locations
- Locations (24)
Kitakyushu Yahata Higashi Hospital
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan
Tochiku Hospital
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan
Nagao Hospital
🇯🇵Fukuoka-city, Fukuoka-prefecture, Japan
Hospital of the University of Occupational and Environmental Health, Japan
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan
Fukuoka Mirai Hospital
🇯🇵Fukuoka-city, Fukuoka-prefecture, Japan
Hakujuji Hospital
🇯🇵Fukuoka-city, Fukuoka-prefecture, Japan
Kitakyushu Abeyamakouen Hospital
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan
Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan
Tobata Rehabilitation Hospital
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan
Sapporo Shiroishi Memorial Hospital
🇯🇵Sapporo-city, Hokkaido-prefecture, Japan
Yoshino Hospital
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan
Tokeidai Memorial Hospital
🇯🇵Sapporo-city, Hokkaido-prefecture, Japan
Hyogo Prefectural Rehabilitation Central Hospital
🇯🇵Kobe-city, Hyogo-prefecture, Japan
Yoshida Hospital, Cerebrovascular Research Institute
🇯🇵Kobe-city, Hyogo-prefecture, Japan
Yamaga Onsen Rehabilitation Hospital
🇯🇵Yamaga-city, Kumamoto-prefecture, Japan
Nichinan Municipal Chubu Hospital
🇯🇵Nichinan-city, Miyazaki-prefecture, Japan
Nagasakikita Hospital
🇯🇵Nishisonogi-gun, Nagasaki-prefecture, Japan
Beppu Rehabilitation Center
🇯🇵Beppu-city, Oita-prefecture, Japan
Ginowan Memorial Hospital
🇯🇵Ginowan-city, Okinawa-prefecture, Japan
Chuzan Hospital
🇯🇵Okinawa-city, Okinawa-prefecture, Japan
Nanbu-Tokushukai Hospital
🇯🇵Shimajiri-gun, Okinawa-prefecture, Japan
Saitama Misato Sogo Rehabilitation Hospital
🇯🇵Misato-city, Saitama-prefecture, Japan
Showa Hospital
🇯🇵Shimonoseki-city, Yamaguchi-prefecture, Japan
Shin-Oji Hospital
🇯🇵Kitakyusyu-city, Fukuoka-prefecture, Japan