UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025480 |
|---|---|
| Receipt number | R000029326 |
| Scientific Title | The study on the usefulness of rehabilitation using smartphone apps for patients after wrist surgery |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/07/03 12:18:12 |
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Basic information
Public title
The study on the usefulness of rehabilitation using smartphone apps for patients after wrist surgery
Acronym
Examination of rehabilitation effect by smartphone apps
Scientific Title
The study on the usefulness of rehabilitation using smartphone apps for patients after wrist surgery
Scientific Title:Acronym
Examination of rehabilitation effect by smartphone apps
Region
| Japan |
Condition
Condition
Distal Radius Fracture, Carpal tunnel syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of smartphone apps for rehabillitaition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
DASH-JSSH at 12 weeks postoperatively
Key secondary outcomes
DASH-JSSH, Grip strength, range of wrist motion at 4,6,8,10,27 weeks postoperatively,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using smartphone apps 10 minutes everyday, from 3-12 weeks postoperatively
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with distal radius fracture or carpal tunnel syndrome who underwent surgeries.
Key exclusion criteria
Patients who
are < 20 years of age.
Can't use smartphone by themselves.
are with Dementia, mental disease which prevent from understanding the research.
are suffering from traffic accident or labor injury.
have another fracture or illness on their upper extremities.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Fujita |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic and Spinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5279
fujiorth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Fujita |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic and Spinal Surgery
Zip code
1138519
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5279
Homepage URL
fujiorth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Internal funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku
Tel
+81358035279
fujiorth@tmd.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2016 | Year | 12 | Month | 30 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029326
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
