UMIN-CTR Clinical Trial

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
Email	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
Email	rehabili@izumoriha-hp.or.jp

Sponsor
Institute	Izumo Shimin Rehabilitation Hospital Rehabilitation Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050419