UMIN-CTR Clinical Trial

Public title

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

Acronym

Clinical effects of peroneal nerve functional electrical stimulation (WalkAide[R]) for chronic stroke patients (PLEASURE trial)

Scientific Title

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

Scientific Title:Acronym

Clinical effects of peroneal nerve functional electrical stimulation (WalkAide[R]) for chronic stroke patients (PLEASURE trial)

Region

Japan

Condition

stroke

Classification by specialty

Neurology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Hachisuka

Organization

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

Division name

President room

Zip code

Address

3-1 Higashiminato-cho, Moji-ku, Kitakyusyu-shi, Japan

TEL

+81-93-331-3461

Email

khachi@mojih.johas.go.jp

Name of contact person

1st name
Middle name
Last name	Mitsuhiro Ochi

Organization

University of Occupational and Environmental Health

Division name

Department of Rehabilitation Medicine

Zip code

Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu

TEL

+81-93-691-7266

Homepage URL

Email

wochi@med.uoeh-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

Teijin Pharma Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

12

Month

02

Day

Date of IRB

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

Other related information

Registered date

2016

Year

01

Month

06

Day

Last modified on

2019

Year

03

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023274