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Trial record 15 of 16 for:    Foot Drop AND meter

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

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ClinicalTrials.gov Identifier: NCT02897752
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Moji Medical Center, Kyusyu Rosai Hospital
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Stroke Device: gait training with WA Other: usual gait training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2016
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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.


  5. 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.

  6. Stroke Impact Scale [ Time Frame: 4weeks ]
    An evaluation of summation score of the total score and physical domain (sixth domain) score.

  7. 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.



Other Outcome Measures:
  1. Improvement of QOL [ Time Frame: 4weeks ]
    Exploratory outcome for improvement of QOL



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897752


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

Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT02897752     History of Changes
Other Study ID Numbers: TRIORTHO1523
UMIN-CTR ( Other Identifier: UMIN000020458 )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
stroke
Rehabilitation
WalkAide (WA)
Functional Electrical Stimulation (FES)

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases