UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020458
Receipt number R000023274
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
Date of disclosure of the study information 2016/01/15
Last modified on 2019/03/08 17:06:04

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Basic information

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

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

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


Public contact

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


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name