UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044422 |
|---|---|
| Receipt number | R000050419 |
| Scientific Title | Comparative Validation of Graded Motor Imagery Interventions for Recovery of Upper Limb Paralysis after Stroke A Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/06/15 |
| Last modified on | 2022/10/01 11:14:51 |
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Basic information
Public title
Comparative Validation of Graded Motor Imagery Interventions for Recovery of Upper Limb Paralysis after Stroke
A Randomized Controlled Trial
Acronym
Comparative Validation of Graded Motor Imagery Interventions for Recovery of Upper Limb Paralysis after Stroke
A Randomized Controlled Trial
Scientific Title
Comparative Validation of Graded Motor Imagery Interventions for Recovery of Upper Limb Paralysis after Stroke
A Randomized Controlled Trial
Scientific Title:Acronym
Comparative Validation of Graded Motor Imagery Interventions for Recovery of Upper Limb Paralysis after Stroke
A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing whether Graded Motor Imagery is beneficial in restoring upper limb function in stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
Key secondary outcomes
Trail Making Test
Motor Activity Log
Simple test for evaluating hand fanction
The Kinesthetic and Visual Imagery Questionnaire
Body ownership question paper
Stroke Impact scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Graded Motor Imagery.30 minutes of intervention per day for 27 days.
Interventions/Control_2
motor imagery.30 minutes of intervention per day for 27 days.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with first stroke who are continuously hospitalized and receiving rehabilitation in the recovery ward of Izumo Municipal Rehabilitation Hospital during the study period
2) Patients aged between 20 and 80 years17)
3) Patients with scores of 1 to 4 on the proximal upper extremity test and distal upper extremity test of the Stroke Impairment Assessment Set (SIAS)
4) Patients scoring less than 3 on the Modified Ashworth Spasticity Scale (MAS)
5) Pain in the paralyzed upper extremity scoring less than 4 out of 10 on the Visual Analog Scale (hereafter referred to as pain VAS)
6) Patients with a score of 24 or higher on the Mini-Mental State Examination (hereinafter referred to as MMSE)
7) Patients who have the verbal ability to perform each assessment and understand the tasks.
8) Patients who have given consent for this study.
Key exclusion criteria
1) Patients participating in other rehabilitation or drug studies.
2) Patients with higher brain dysfunction that interferes with intervention and evaluation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | ATUSHI |
| Middle name | |
| Last name | NAGAI |
Organization
Shimane University School of Medicine
Division name
Internal Medicine III
Zip code
693-8501
Address
89-1 Shioji-cho, Izumo City, Shimane Prefecture
TEL
0853-20-2198
anagai@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | yuto |
| Middle name | |
| Last name | kishi |
Organization
Izumo Shimin Rehabilitation Hospital
Division name
Rehabilitation Medicine
Zip code
693-0033
Address
238 Chiimiyacho, Izumo-shi, Shimane-ken
TEL
0853-21-2733
Homepage URL
rehabili@izumoriha-hp.or.jp
Sponsor or person
Institute
Izumo Shimin Rehabilitation Hospital
Rehabilitation Medicine
Institute
Department
Personal name
Funding Source
Organization
Izumo Shimin Rehabilitation Hospital
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
Izumo Shimin Rehabilitation Hospital
Address
238 Chiimiyacho, Izumo-shi, Shimane-ken
Tel
0853-21-2733
rehabili@izumoriha-hp.or.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 | 06 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2021 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050419
