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

NCT02897752 | Completed DMC

• 2 other identifiers: TRIORTHO1523UMIN-CTR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 24

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.

Conditions

Stroke

Keywords

stroke; Rehabilitation; WalkAide (WA); Functional Electrical Stimulation (FES)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Lower extremity subscale of the Fugl-Meyer Assessment

  4weeks

• Muscle strength of the ankle dorsiflexor muscle

  4weeks

• Ankle dorsiflexion range of motion

  4weeks

• Modified Ashworth Scale for the plantar flexor muscle

  4weeks

• 10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed).

  4weeks

Other Outcomes (1)

• Improvement of QOL

  4weeks

Study Arms (2)

WalkAide

EXPERIMENTAL

Device: gait training with WA

Usual gait Training

ACTIVE COMPARATOR

Other: usual gait training

Interventions

gait training with WA DEVICE

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.

WalkAide

usual gait training OTHER

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.

Usual gait Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• )First-ever hemiplegic patients 4 months after the stroke onset
• )Patients whose the lower extremity paralysis is estimated to be stage IV, V or VI according to the Brunnstrom stage
• )Patients whose spasticity of the plantar flexor muscle is estimated at 2 or less according to the Modified Ashworth Scale
• )Patients whose ankle dorsiflexion range of motion is 0 degree or more
• )Patients whose gait performance is estimated to be 5 or 6 according to the FAC
• )Patients who can understand the purpose and instructions of this study and complete the training
• )Patients who agree to participate in this study and provide their written informed consent

You may not qualify if:

• )Patients whose ankle dorsiflexion is not induced by the WA due to peripheral neuropathy
• )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)
• )Patients who underwent Botox treatment in the lower extremities within 3 months of this study registry
• )Patients who have nervous system (excluding stroke), cardio-respiratory system, or musculoskeletal system disorders, which may affect gait and training
• )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
• )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.
• \) Patients who are regarded to be ineligible for this study by the principal investigator or co-investigators

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Moji Medical Center, Kyusyu Rosai Hospital: collaborator

Study Sites (24)

Fukuoka Mirai Hospital

Fukuoka, Fukuoka, 813-0017, Japan

Location

Nagao Hospital

Fukuoka, Fukuoka, 814-0153, Japan

Location

Hakujuji Hospital

Fukuoka, Fukuoka, 819-8511, Japan

Location

Kitakyushu Abeyamakouen Hospital

Kitakyushu, Fukuoka, 800-0257, Japan

Location

Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization

Kitakyushu, Fukuoka, 801-8502, Japan

Location

Tobata Rehabilitation Hospital

Kitakyushu, Fukuoka, 804-0092, Japan

Location

Kitakyushu Yahata Higashi Hospital

Kitakyushu, Fukuoka, 805-0061, Japan

Location

Shin-Oji Hospital

Kitakyushu, Fukuoka, 806-0057, Japan

Location

Tochiku Hospital

Kitakyushu, Fukuoka, 807-0856, Japan

Location

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, 807-8555, Japan

Location

Yoshino Hospital

Kitakyushu, Fukuoka, 808-0034, Japan

Location

Sapporo Shiroishi Memorial Hospital

Sapporo, Hokkaido-prefecture, 003-0026, Japan

Location

Tokeidai Memorial Hospital

Sapporo, Hokkaido-prefecture, 060-0031, Japan

Location

Hyogo Prefectural Rehabilitation Central Hospital

Kobe, Hyōgo, 651-2181, Japan

Location

Yoshida Hospital, Cerebrovascular Research Institute

Kobe, Hyōgo, 652-0803, Japan

Location

Yamaga Onsen Rehabilitation Hospital

Yamaga, Kumamoto, 861-0514, Japan

Location

Nichinan Municipal Chubu Hospital

Nichinan, Miyazaki, 889-3141, Japan

Location

Nagasakikita Hospital

Nishisonogi-gun, Nagasaki, 851-2103, Japan

Location

Beppu Rehabilitation Center

Beppu, Oita Prefecture, 874-8611, Japan

Location

Ginowan Memorial Hospital

Ginowan, Okinawa, 901-2211, Japan

Location

Chuzan Hospital

Okinawa, Okinawa, 904-2151, Japan

Location

Nanbu-Tokushukai Hospital

Shimajiri-gun, Okinawa, 901-0493, Japan

Location

Saitama Misato Sogo Rehabilitation Hospital

Misato, Saitama, Saitama, 341-0034, Japan

Location

Showa Hospital

Shimonoseki, Yamaguchi, 750-0059, Japan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kenji Hachisuka, MD, Ph.D

  Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: September 13, 2016
• Study Start: March 23, 2016
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

JP (24)