Clinical trial NCT02897752: Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients
Official title: Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for the Lower Extremities in Chronic Stroke Patients With Hemiplegia: A Multicenter, Prospective, Randomized Controlled Trial
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: Moji Medical Center, Kyusyu Rosai Hospital
First posted: 2016-09-13
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 1)Patients whose ankle dorsiflexion is not induced by the WA due to peripheral neuropathy
* 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)
* 3)Patients who underwent Botox treatment in the lower extremities within 3 months of this study registry
* 4)Patients who have nervous system (excluding stroke), cardio-respiratory system, or musculoskeletal system disorders, which may affect gait and training
* 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
* 6)Patients whose impairment severities changed between the prior and initial assessments

  * Definition of an alteration

    1. 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.
    2. 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.
    3. 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.
* 7) Patients who are regarded to be ineligible for this study by the principal investigator or co-investigators

Primary outcomes:
measure: 6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort)
timeFrame: 4weeks
Secondary outcomes:
measure: Lower extremity subscale of the Fugl-Meyer Assessment
timeFrame: 4weeks
measure: Muscle strength of the ankle dorsiflexor muscle
timeFrame: 4weeks
measure: Ankle dorsiflexion range of motion
timeFrame: 4weeks
measure: Modified Ashworth Scale for the plantar flexor muscle
timeFrame: 4weeks
measure: 10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed).
timeFrame: 4weeks
measure: Stroke Impact Scale
timeFrame: 4weeks
measure: Adverse event assessment
timeFrame: 4weeks
Other outcomes:
measure: Improvement of QOL
timeFrame: 4weeks
Locations:
city: Fukuoka-city
country: Japan
facility: Fukuoka Mirai Hospital
state: Fukuoka-prefecture
city: Fukuoka-city
country: Japan
facility: Nagao Hospital
state: Fukuoka-prefecture
city: Fukuoka-city
country: Japan
facility: Hakujuji Hospital
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Kitakyushu Abeyamakouen Hospital
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Tobata Rehabilitation Hospital
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Kitakyushu Yahata Higashi Hospital
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Shin-Oji Hospital
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Tochiku Hospital
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Fukuoka-prefecture
city: Kitakyusyu-city
country: Japan
facility: Yoshino Hospital
state: Fukuoka-prefecture
city: Sapporo-city
country: Japan
facility: Sapporo Shiroishi Memorial Hospital
state: Hokkaido-prefecture
city: Sapporo-city
country: Japan
facility: Tokeidai Memorial Hospital
state: Hokkaido-prefecture
city: Kobe-city
country: Japan
facility: Hyogo Prefectural Rehabilitation Central Hospital
state: Hyogo-prefecture
city: Kobe-city
country: Japan
facility: Yoshida Hospital, Cerebrovascular Research Institute
state: Hyogo-prefecture
city: Yamaga-city
country: Japan
facility: Yamaga Onsen Rehabilitation Hospital
state: Kumamoto-prefecture
city: Nichinan-city
country: Japan
facility: Nichinan Municipal Chubu Hospital
state: Miyazaki-prefecture
city: Nishisonogi-gun
country: Japan
facility: Nagasakikita Hospital
state: Nagasaki-prefecture
city: Beppu-city
country: Japan
facility: Beppu Rehabilitation Center
state: Oita-prefecture
city: Ginowan-city
country: Japan
facility: Ginowan Memorial Hospital
state: Okinawa-prefecture
city: Okinawa-city
country: Japan
facility: Chuzan Hospital
state: Okinawa-prefecture
city: Shimajiri-gun
country: Japan
facility: Nanbu-Tokushukai Hospital
state: Okinawa-prefecture
city: Misato-city
country: Japan
facility: Saitama Misato Sogo Rehabilitation Hospital
state: Saitama-prefecture
city: Shimonoseki-city
country: Japan
facility: Showa Hospital
state: Yamaguchi-prefecture
Study officials:
affiliation: Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
name: Kenji Hachisuka, MD, Ph.D
role: STUDY_CHAIR
References: