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

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: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: gait training with WA; Other: usual gait training

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	4weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4weeks
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.	4weeks
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).	4weeks
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.	4weeks
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.	4weeks
Stroke Impact Scale	An evaluation of summation score of the total score and physical domain (sixth domain) score.	4weeks
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.	4weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of QOL	Exploratory outcome for improvement of QOL	4weeks

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Moji Medical Center, Kyusyu Rosai Hospital
• Investigators: Study Chair: Kenji Hachisuka, MD, Ph.D, Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): December 7, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; stroke; WalkAide (WA); Functional Electrical Stimulation (FES)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: TRIORTHO1523; UMIN-CTR (Other Identifier: UMIN000020604)