UMIN-CTR Clinical Trial

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 Manabu Middle name Last name Yoshimura
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Laboratory of Analysis & Control of Upper Extremity Function
Zip code	734-0037
Address	1-2-3Kasumi,Minami-ku,Hiroshima
TEL	082-257-5555
Email	mnb328@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Manabu Middle name Last name Yoshimura
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Laboratory of Analysis & Control of Upper Extremity Function
Zip code	734-0037
Address	1-2-3Kasumi,Minami-ku,Hiroshima
TEL	082-257-5555
Homepage URL
Email	mnb328@med.kawasaki-m.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	Kawasaki medical university
Address	577 Matsushima, Kurashiki
Tel	0864621111
Email	kmsrec@med.kawasaki-m.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	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	11
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	No longer recruiting
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	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	None

Management information
Registered date	2018 Year 07 Month 15 Day
Last modified on	2021 Year 07 Month 27 Day

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