UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033392 |
|---|---|
| Receipt number | 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 | 2021/07/27 10:59:33 |
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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 | 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
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
mnb328@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038072
