UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039663 |
|---|---|
| Receipt number | R000045237 |
| Scientific Title | The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/02 15:43:48 |
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Basic information
Public title
The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb: A crossover randomized controlled trial
Acronym
The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb
Scientific Title
The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb
Scientific Title:Acronym
The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This retrospective crossover randomized controlled trial aimed to examine the effect of PA-EST on the daily life of patients with chronic severely paralyzed 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
Goal Attainment Scaling Light
Motor Activity Log
Modified Ashworth Scale
US echo
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
The subjects were stratified as per sex and physical function; they were then randomly divided into groups A and B. Group A received PA-EST for 3 month, followed by regular stretching and exercise training for 3 month after a rest period of 1 month.
Interventions/Control_2
In group B, stretching exercises were mainly performed for 3 month, and PA-EST was administered for 3 month after a rest period of 1 month.
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subject has lived at home more than three years after the onset of stroke.
The subject has motor function of the upper limbs of brunnstrom recovery stage 1 form 3.
The subject has intervention of home based occupational therapy at least once a week.
The subject can talk about the situation of daily life.
Key exclusion criteria
The subject uses a demand-type cardiac pacemaker.
In the subject, the electrical stimulation is directly stimulated by the malignant tumor.
The subject has a fracture at the location where the electrical stimulation was applied.
Subject has not obtained permission from the attending physician.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Minami |
| Middle name | Seigo |
| Last name | male |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Occupational Therapy
Zip code
597-0104
Address
158, Mizuma, Kaizuka City, Osaka.
TEL
0724466700
minamise@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | Seigo |
| Last name | male |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Occupational Therapy
Zip code
597-0104
Address
158, Mizuma, Kaizuka City, Osaka.
TEL
0724466700
Homepage URL
minamise@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Kawasaki Rehabilitation University
Address
158, Mizuma, Kaizuka City, Osaka.
Tel
0724466700
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
| 2020 | Year | 04 | Month | 01 | 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
8
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 | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045237
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| Registered date | File name |
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| Registered date | File name |
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