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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033392
Receipt No. R000038072
Scientific Title Effect of change in motor imagery after upper limb amputation on prosthetic operability and phantom limb pain.
Date of disclosure of the study information 2018/08/01
Last modified on 2019/07/17

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Basic information
Public title Effect of change in motor imagery after upper limb amputation on prosthetic operability and phantom limb pain.
Acronym Effect of change in motor imagery after upper limb amputation on prosthetic operability and phantom limb pain.
Scientific Title Effect of change in motor imagery after upper limb amputation on prosthetic operability and phantom limb pain.
Scientific Title:Acronym Effect of change in motor imagery after upper limb amputation on prosthetic operability and phantom limb pain.
Region
Japan

Condition
Condition Patients with upper limb amputation
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Participants were upper limb amputees with different years after amputation. The aim of this study was to investigate the effect of changes in the motor imagery after upper limb amputation on prosthetic operability and phantom limb pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The motor imagery is evaluated by the reaction time and correct answer rate of the hand mental rotation task.
Key secondary outcomes Prosthetic operability is evaluated by the score of Box and Block test. The intensity of phantom limb pain is evaluated in Visual Analog Scale.
The vividness of the motor imagery is evaluated by The Kinesthetic and Visual Imagery Questionnaire-20(KVIQ-20) and the catastrophic thought of pain is evaluated using Pain Catastrophizing Scale (PCS).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Upper limb amputees (forearm) with consents.
Key exclusion criteria Subject with dementia (MMSE<21)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Yoshimura
Organization Hiroshima University Graduate School of Biomedical & Health Sciences
Division name Laboratory of Analysis & Control of Upper Extremity Function
Zip code
Address 1-2-3Kasumi,Minami-ku,Hiroshima
TEL 082-257-5555
Email d180255@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Yoshimura
Organization Hiroshima University Graduate School of Biomedical & Health Sciences
Division name Laboratory of Analysis & Control of Upper Extremity Function
Zip code
Address 1-2-3Kasumi,Minami-ku,Hiroshima
TEL 082-257-5555
Homepage URL
Email d180255@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization The KAWASAKI Foundation for Medical Science and Medical Welfare
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 川崎医科大学附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 15 Day
Date of IRB
2019 Year 06 Month 11 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2020 Year 01 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 07 Month 15 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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