UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effects of peroneal nerve functional electrical stimulation (WalkAide[R]) for the lower extremities in chronic stroke patients with hemiplegia: A multicneter, prospective, randomized controlled trial
Title of the study (Brief title)	Clinical effects of peroneal nerve functional electrical stimulation (WalkAide[R]) for chronic stroke patients (PLEASURE trial)
Region	Japan

Condition
Condition	stroke
Classification by specialty	Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal whether gait training with the WalkAide[R](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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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 wearing neither the WA nor ankle-foot orthosis (AFO)before and after each intervention in the WA-asssisted training group (WA group) and usual training group (UT group).
Key secondary outcomes	1)Lower extremity subscale of the Fugl-Meyer Assessment 2)Muscle strength of the ankle dorsiflexor muscle 3)Ankle dorsiflexion range of motion 4)Modified Ashworth Scale for the plantar flexor muscle 5)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 wearing neither the WA nor AFO before and after each intervention in the WA and UT groups 6)Stroke Impact Scale 7)Adverse event assessment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intervention: 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.
Interventions/Control_2	Control: 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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)Brunnstorm 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
Target sample size	120

Research contact person
Name of lead principal investigator	Kenji Hachisuka
Organization	Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
Division name	President room
Address	3-1 Higashiminato-cho, Moji-ku, Kitakyusyu-shi, Japan
TEL	+81-93-331-3461
Email	khachi@mojih.johas.go.jp

Public contact
Name of contact person	Mitsuhiro Ochi
Organization	University of Occupational and Environmental Health
Division name	Department of Rehabilitation Medicine
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL	+81-93-691-7266
Homepage URL
Email	wochi@med.uoeh-u.ac.jp

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

Funding Source
Organization	Teijin Pharma Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 02 Day
Anticipated trial start date	2016 Year 01 Month 29 Day
Last follow-up date	2017 Year 07 Month 30 Day
Date of closure to data entry	2017 Year 10 Month 10 Day
Date trial data considered complete	2017 Year 12 Month 07 Day
Date analysis concluded	2018 Year 10 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 06 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023274