UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043499 |
|---|---|
| Receipt number | R000049506 |
| Scientific Title | Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation: randomized-control trial |
| Date of disclosure of the study information | 2021/03/02 |
| Last modified on | 2021/09/01 09:24:15 |
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Basic information
Public title
Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation
Acronym
Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation: randomized-control trial
Scientific Title
Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation: randomized-control trial
Scientific Title:Acronym
Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation: randomized-control trial
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to perform PA-EST(Purposeful Activity and Electrical Stimulation Therapy) on patients with severe hemiplegic upper limbs in the convalescent ward and confirm the effects of daily activities on the upper limbs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl Meyer Assessment
Key secondary outcomes
Motor activity log, Functional independence measure, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PA-EST(Purposeful Activity and Electrical Stimulation Therapy: PA-EST) /functional occupational therapy
Interventions/Control_2
Frequency: 5 times or more / week
Time: about 60 minutes
Duration: 1-2 months or 3 months
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were selected as those who entered the recovery phase rehabilitation ward and had a Hasegawa dementia rating scale-revised of 28 points or more, and the Fugl Meyer Assessment (FMA) motor function (upper limbs / lower limbs) of 50 points or less. In addition, the FMA upper limb score was 30 points or less. The condition is occupational therapy intervention, and cognitive function is capable of conversation in daily life.
Key exclusion criteria
Exclusion criteria were those with a history of seizures, those with a pacemaker, and those with prominent higher brain dysfunction.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Minami |
| Middle name | |
| Last name | Seigo |
Organization
Gunma Paz University
Division name
Faculty of Rehabilitation
Zip code
370-0006
Address
1-7-1 Tonyamachi, takasaki-city, Gunma
TEL
027-365-3366
seigo.minami@gmail.com
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Seigo |
Organization
Gunma Paz University
Division name
Faculty of Rehabilitation
Zip code
597-0104
Address
1-7-1 Tonyamachi, takasaki-city, Gunma
TEL
027-365-3366
Homepage URL
seigo.minami@gmail.com
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Kawasaki Rehabilitation University, Japan
Address
158, Mizuma, Kaizuka, Osaka, Japan
Tel
0727766700
minamise@kawasakigakuen.ac.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
| 2021 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
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
| 2018 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049506
