Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients (PLEASURE)

April 17, 2018 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Fukuoka-prefecture
      • Fukuoka-city, Fukuoka-prefecture, Japan, 813-0017
        • Fukuoka Mirai Hospital
      • Fukuoka-city, Fukuoka-prefecture, Japan, 814-0153
        • Nagao Hospital
      • Fukuoka-city, Fukuoka-prefecture, Japan, 819-8511
        • Hakujuji Hospital
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 800-0257
        • Kitakyushu Abeyamakouen Hospital
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 801-8502
        • Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 804-0092
        • Tobata Rehabilitation Hospital
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 805-0061
        • Kitakyushu Yahata Higashi Hospital
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 806-0057
        • Shin-Oji Hospital
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 807-0856
        • Tochiku Hospital
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 807-8555
        • Hospital of the University of Occupational and Environmental Health, Japan
      • Kitakyusyu-city, Fukuoka-prefecture, Japan, 808-0034
        • Yoshino Hospital
    • Hokkaido-prefecture
      • Sapporo-city, Hokkaido-prefecture, Japan, 003-0026
        • Sapporo Shiroishi Memorial Hospital
      • Sapporo-city, Hokkaido-prefecture, Japan, 060-0031
        • Tokeidai Memorial Hospital
    • Hyogo-prefecture
      • Kobe-city, Hyogo-prefecture, Japan, 651-2181
        • Hyogo Prefectural Rehabilitation Central Hospital
      • Kobe-city, Hyogo-prefecture, Japan, 652-0803
        • Yoshida Hospital, Cerebrovascular Research Institute
    • Kumamoto-prefecture
      • Yamaga-city, Kumamoto-prefecture, Japan, 861-0514
        • Yamaga Onsen Rehabilitation Hospital
    • Miyazaki-prefecture
      • Nichinan-city, Miyazaki-prefecture, Japan, 889-3141
        • Nichinan Municipal Chubu Hospital
    • Nagasaki-prefecture
      • Nishisonogi-gun, Nagasaki-prefecture, Japan, 851-2103
        • Nagasakikita Hospital
    • Oita-prefecture
      • Beppu-city, Oita-prefecture, Japan, 874-8611
        • Beppu Rehabilitation Center
    • Okinawa-prefecture
      • Ginowan-city, Okinawa-prefecture, Japan, 901-2211
        • Ginowan Memorial Hospital
      • Okinawa-city, Okinawa-prefecture, Japan, 904-2151
        • Chuzan Hospital
      • Shimajiri-gun, Okinawa-prefecture, Japan, 901-0493
        • Nanbu-Tokushukai Hospital
    • Saitama-prefecture
      • Misato-city, Saitama-prefecture, Japan, 341-0034
        • Saitama Misato Sogo Rehabilitation Hospital
    • Yamaguchi-prefecture
      • Shimonoseki-city, Yamaguchi-prefecture, Japan, 750-0059
        • Showa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WalkAide
Device: gait training with WA
Thirty seven units (1 unit=20 minutes) of gait training with WA by a physical therapist for the WA group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.
Active Comparator: Usual gait Training
Other: usual gait training
Thirty seven units of usual gait training by a physical therapist for the UT group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort)
Time Frame: 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).
4weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower extremity subscale of the Fugl-Meyer Assessment
Time Frame: 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).
4weeks
Muscle strength of the ankle dorsiflexor muscle
Time Frame: 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.
4weeks
Ankle dorsiflexion range of motion
Time Frame: 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).
4weeks
Modified Ashworth Scale for the plantar flexor muscle
Time Frame: 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.
4weeks
10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed).
Time Frame: 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.
4weeks
Stroke Impact Scale
Time Frame: 4weeks
An evaluation of summation score of the total score and physical domain (sixth domain) score.
4weeks
Adverse event assessment
Time Frame: 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.
4weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement of QOL
Time Frame: 4weeks
Exploratory outcome for improvement of QOL
4weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Moji Medical Center, Kyusyu Rosai Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kenji Hachisuka, MD, Ph.D, Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRIORTHO1523
  • UMIN-CTR (Other Identifier: UMIN000020604)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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