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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042629
Receipt No. R000048522
Scientific Title Synergetic effect of Functional Electrical Stimulation Therapy and Trunk Orthosis with joints providing resistive force for Inpatients with Stroke Hemiplegia in a Convalescent Rehabilitation Ward
Date of disclosure of the study information 2020/12/02
Last modified on 2020/12/02

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Basic information
Public title Synergetic effect of Functional Electrical Stimulation Therapy and Trunk Orthosis with joints providing resistive force for Inpatients with Stroke Hemiplegia in a Convalescent Rehabilitation Ward
Acronym Synergetic effect of FES and Trunk Orthosis with joints providing resistive force for patients with Stroke
Scientific Title Synergetic effect of Functional Electrical Stimulation Therapy and Trunk Orthosis with joints providing resistive force for Inpatients with Stroke Hemiplegia in a Convalescent Rehabilitation Ward
Scientific Title:Acronym Synergetic effect of FES and Trunk Orthosis with joints providing resistive force for patients with Stroke
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to investigate the synergetic effect and the adaptation of Functional Electrical Stimulation Therapy and Trunk Orthosis with joints providing resistive force for inpatients with stroke hemiplegia in a convalescent rehabilitation ward.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10-meter walking test
Key secondary outcomes Stroke Impairment Assessment Set
range of motion on ankle dorsiflexion
Functional Assessment for Control of Trunk

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Functional electrical stimulation
Trunk Orthosis with joints providing resistive force
Interventions/Control_2
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Recovering Stroke Hemiplegic Patients
Indications for Functional Electrical Stimulation Therapy
Adaptation of the Trunk Solution
10 m walkable
Key exclusion criteria Difficulty in understanding instructions, such as severe aphasia
Significant ataxia
Pure perxonism
Comorbidities of obvious painful diseases and orthopedic conditions
Vital signs unstable
Target sample size 11

Research contact person
Name of lead principal investigator
1st name Yamashige
Middle name
Last name Taiki
Organization Midori hospital,general rehabilitation center
Division name rehabilitation department
Zip code 9500983
Address niigataken niigatashi chuuouku kandouji 2-5-1
TEL 0252440080
Email midori-pt@midori-gr.jp

Public contact
Name of contact person
1st name Yamashige
Middle name
Last name Taiki
Organization Midori hospital,general rehabilitation center
Division name rehabilitation department
Zip code 9500983
Address niigataken niigatashi chuuouku kandouji 2-5-1
TEL 0252440080
Homepage URL
Email midori-pt@midori-gr.jp

Sponsor
Institute Midori hospital,general rehabilitation center
Institute
Department

Funding Source
Organization France Bed CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Midori hospital,general rehabilitation center
Address niigataken niigatashi chuuouku kandouji 2-5-1
Tel 0252440080
Email midori-pt@midori-gr.jp

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
2020 Year 12 Month 02 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 11
Results Synergetic effect of functional electrical stimulation and Trunk Orthosis with joints providing resistive force significantly improved gait speed. Decreased trunk function was found be a characteristic of the synergetic effect of functional electrical stimulation and Trunk Orthosis with joints providing resistive force.
Results date posted
2020 Year 11 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Recovering Stroke Hemiplegic Patients
Indications for Functional Electrical Stimulation Therapy
Adaptation of the Trunk Orthosis with joints providing resistive force
10 m walkable
Participant flow Thirteen people participated, but one patient stopped rehabilitation due to hypertension and one patient stopped due to mental instability caused by the evaluation, resulting in the completion of 11 participants.
Adverse events Discontinuation of rehabilitation due to high blood pressure in one case
Mental instability due to the assessment was observed and discontinued in one case
No adverse events were identified for functional electrical stimulation and the Trunk Orthosis with joints providing resistive force.
Outcome measures 10m-walking test
Stroke Impairment Assessment Set:SIAS
ankle angle
Functional Assessment for Control of Trunk:FACT
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
2018 Year 11 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 29 Day
Last follow-up date
2019 Year 12 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 02 Day
Last modified on
2020 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048522

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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