UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042629 |
|---|---|
| Receipt number | 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 | 2023/05/08 10:55:53 |
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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 | Taiki |
| Middle name | |
| Last name | Yamashige |
Organization
Midori hospital,general rehabilitation center
Division name
rehabilitation department
Zip code
9500983
Address
niigataken niigatashi chuuouku kandouji 2-5-1
TEL
0252440080
midori-pt@midori-gr.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yamashige |
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
midori-pt@midori-gr.jp
Sponsor or person
Institute
Midori hospital,general rehabilitation center
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/jspo/38/2/38_159/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jspo/38/2/38_159/_pdf/-char/ja
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
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048522
