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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020458
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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