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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
gait training with WA
usual gait training
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fukuoka Mirai Hospital
  • Nagao Hospital
  • Hakujuji Hospital
  • Kitakyushu Abeyamakouen Hospital
  • Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
  • Tobata Rehabilitation Hospital
  • Kitakyushu Yahata Higashi Hospital
  • Shin-Oji Hospital
  • Tochiku Hospital
  • Hospital of the University of Occupational and Environmental Health, Japan
  • Yoshino Hospital
  • Sapporo Shiroishi Memorial Hospital
  • Tokeidai Memorial Hospital
  • Hyogo Prefectural Rehabilitation Central Hospital
  • Yoshida Hospital, Cerebrovascular Research Institute
  • Yamaga Onsen Rehabilitation Hospital
  • Nichinan Municipal Chubu Hospital
  • Nagasakikita Hospital
  • Beppu Rehabilitation Center
  • Ginowan Memorial Hospital
  • Chuzan Hospital
  • Nanbu-Tokushukai Hospital
  • Saitama Misato Sogo Rehabilitation Hospital
  • Showa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WalkAide

Usual gait Training

Arm Description

Outcomes

Primary Outcome Measures

6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort)
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

Lower extremity subscale of the Fugl-Meyer Assessment
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
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
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
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).
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
An evaluation of summation score of the total score and physical domain (sixth domain) score.
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 protocol treatment.

Full Information

First Posted
August 5, 2016
Last Updated
April 17, 2018
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Moji Medical Center, Kyusyu Rosai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02897752
Brief Title
Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients
Acronym
PLEASURE
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Moji Medical Center, Kyusyu Rosai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WalkAide
Arm Type
Experimental
Arm Title
Usual gait Training
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
gait training with WA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
usual gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort)
Description
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).
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
Lower extremity subscale of the Fugl-Meyer Assessment
Description
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).
Time Frame
4weeks
Title
Muscle strength of the ankle dorsiflexor muscle
Description
An evaluation of the value(Newton/kg) using the ankle back flexor force of three times measured on average, divided by the weight value.
Time Frame
4weeks
Title
Ankle dorsiflexion range of motion
Description
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).
Time Frame
4weeks
Title
Modified Ashworth Scale for the plantar flexor muscle
Description
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.
Time Frame
4weeks
Title
10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed).
Description
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.
Time Frame
4weeks
Title
Stroke Impact Scale
Description
An evaluation of summation score of the total score and physical domain (sixth domain) score.
Time Frame
4weeks
Title
Adverse event assessment
Description
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.
Time Frame
4weeks
Other Pre-specified Outcome Measures:
Title
Improvement of QOL
Description
Exploratory outcome for improvement of QOL
Time Frame
4weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 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. 7) Patients who are regarded to be ineligible for this study by the principal investigator or co-investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenji Hachisuka, MD, Ph.D
Organizational Affiliation
Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
Official's Role
Study Chair
Facility Information:
Facility Name
Fukuoka Mirai Hospital
City
Fukuoka-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
Nagao Hospital
City
Fukuoka-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
814-0153
Country
Japan
Facility Name
Hakujuji Hospital
City
Fukuoka-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
819-8511
Country
Japan
Facility Name
Kitakyushu Abeyamakouen Hospital
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
800-0257
Country
Japan
Facility Name
Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
801-8502
Country
Japan
Facility Name
Tobata Rehabilitation Hospital
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
804-0092
Country
Japan
Facility Name
Kitakyushu Yahata Higashi Hospital
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
805-0061
Country
Japan
Facility Name
Shin-Oji Hospital
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
806-0057
Country
Japan
Facility Name
Tochiku Hospital
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
807-0856
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Yoshino Hospital
City
Kitakyusyu-city
State/Province
Fukuoka-prefecture
ZIP/Postal Code
808-0034
Country
Japan
Facility Name
Sapporo Shiroishi Memorial Hospital
City
Sapporo-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
003-0026
Country
Japan
Facility Name
Tokeidai Memorial Hospital
City
Sapporo-city
State/Province
Hokkaido-prefecture
ZIP/Postal Code
060-0031
Country
Japan
Facility Name
Hyogo Prefectural Rehabilitation Central Hospital
City
Kobe-city
State/Province
Hyogo-prefecture
ZIP/Postal Code
651-2181
Country
Japan
Facility Name
Yoshida Hospital, Cerebrovascular Research Institute
City
Kobe-city
State/Province
Hyogo-prefecture
ZIP/Postal Code
652-0803
Country
Japan
Facility Name
Yamaga Onsen Rehabilitation Hospital
City
Yamaga-city
State/Province
Kumamoto-prefecture
ZIP/Postal Code
861-0514
Country
Japan
Facility Name
Nichinan Municipal Chubu Hospital
City
Nichinan-city
State/Province
Miyazaki-prefecture
ZIP/Postal Code
889-3141
Country
Japan
Facility Name
Nagasakikita Hospital
City
Nishisonogi-gun
State/Province
Nagasaki-prefecture
ZIP/Postal Code
851-2103
Country
Japan
Facility Name
Beppu Rehabilitation Center
City
Beppu-city
State/Province
Oita-prefecture
ZIP/Postal Code
874-8611
Country
Japan
Facility Name
Ginowan Memorial Hospital
City
Ginowan-city
State/Province
Okinawa-prefecture
ZIP/Postal Code
901-2211
Country
Japan
Facility Name
Chuzan Hospital
City
Okinawa-city
State/Province
Okinawa-prefecture
ZIP/Postal Code
904-2151
Country
Japan
Facility Name
Nanbu-Tokushukai Hospital
City
Shimajiri-gun
State/Province
Okinawa-prefecture
ZIP/Postal Code
901-0493
Country
Japan
Facility Name
Saitama Misato Sogo Rehabilitation Hospital
City
Misato-city
State/Province
Saitama-prefecture
ZIP/Postal Code
341-0034
Country
Japan
Facility Name
Showa Hospital
City
Shimonoseki-city
State/Province
Yamaguchi-prefecture
ZIP/Postal Code
750-0059
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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