UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039973 |
|---|---|
| Receipt number | R000045575 |
| Scientific Title | Development of upper limb function training program using EMG biofeedback and motor imagery :The effect of motor imagery training by action observation in rehabilitation of distal radius fracture |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2025/04/03 05:45:18 |
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Basic information
Public title
The effect of motor imagery training by action observation in rehabilitation of distal radius fracture
Acronym
Case control study
Scientific Title
Development of upper limb function training program using EMG biofeedback and motor imagery :The effect of motor imagery training by action observation in rehabilitation of distal radius fracture
Scientific Title:Acronym
Case control study
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify the effects of intervention.Exercise motor image exercise program by visual observation for distal radius fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of motion
Key secondary outcomes
Self estimation of Wrist range motion
Grip strength
Patient Related Wrist Evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1.Intervention group
in addition to action observation exercises by video with regular rehabilitation program.
Duration is one month from the start of rehabilitation.
Conduct at least once a week.
Interventions/Control_2
2.Control group
Perform only regular rehabilitation at the same time as the intervention group.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with distal radius fracture (include TFCC damage, ulnar styloid fracture).
Key exclusion criteria
1.Central nervous system disease
2.Dementia
3.Communication disorder
4.Patients with upper limb orthopedic disease other than distal radius fracture (TFCC damage, ulnar styloid fracture).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Usuki |
Organization
Saitama Prefectural University Graduate School.
kitasato University medical center
Division name
Department of rehabilitation
Zip code
364-8501
Address
Arai 6-100 Kitamoto city Saitama prefecture
TEL
048-593-1212
k-usuki@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Usuki |
Organization
Kitasato University medical center
Division name
Department of rehabilitation
Zip code
364-8501
Address
Arai 6-100 Kitamoto city Saitama prefecture
TEL
048-593-1212
Homepage URL
k-usuki@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Saitama prefectural University
Institute
Department
Personal name
Funding Source
Organization
Saitama prefectural University
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
Kitasato University medical Center
Address
Arai 6-100 Kitamoto city Saitama prefecture
Tel
048-593-1212
k-usuki@insti.kitasato-u.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
北里大学メディカルセンター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | 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
42
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Manuscript in preparation
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045575
