UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053346 |
|---|---|
| Receipt number | R000060885 |
| Scientific Title | Intervention study of visualizing and exercising upper limb activity using accelerometers in postoperative patients with distal radius fractures |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/01/13 20:05:29 |
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Basic information
Public title
Usefulness of visualizing and exercising upper extremity activity with accelerometers in postoperative patients with distal radius fractures
Acronym
Usefulness of monitoring upper extremity activity and exercising with accelerometers in postoperative patients with distal radius fractures
Scientific Title
Intervention study of visualizing and exercising upper limb activity using accelerometers in postoperative patients with distal radius fractures
Scientific Title:Acronym
Intervention study of visualizing and exercising upper extremity activity, in postoperative patients with distal radius fractures
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to visualize the amount of upper limb activity using an accelerometer to improve the frequency of upper limb use in daily life and to use it as an index for patient guidance in order to improve the functional recovery of patients after distal radius fracture surgery, and to verify the effectiveness of the treatment.
Basic objectives2
Others
Basic objectives -Others
Range of motion of joints
Muscle strength
Ability to perform ADLs
DASH-JSSH
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective hand performance at 3, 6, 9, and 12 weeks postoperatively(Disabilities of the Arm, Shoulder and Hand The JSSH Version:DASH-JSSH).
Key secondary outcomes
Amount of activity, range of motion of automatic joints (palmar and dorsal flexion, radial and ulnar flexion, and forearm pronation/supination), and Patient-Rated Wrist Evaluation The Japanese Version (PRWE-J) at 3, 6, 9, and 12 weeks postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
At 3, 6, 9, and 12 weeks postoperatively, the patients will be fitted with accelerometers in both wrist joints for one day (24 hours). The amount of activity will be visualized, and occupational therapy will be conducted by having the patients confirm the use of their hands in daily life.
Interventions/Control_2
At 3, 6, 9, and 12 weeks postoperatively, the patients will be fitted with accelerometers in both wrist joints for one day (24 hours).The amount of activity is not visualized.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient who underwent volar locking plate fixation after distal radius fracture
The one that is based on the patient's opinion and understanding
20 years old and over
Key exclusion criteria
Multiple trauma cases
Patients with cerebrovascular disease, peripheral nerve injury, tendon injury, or orthopedic upper limb disease as pre-existing conditions or complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Manami |
| Middle name | |
| Last name | Jibiki |
Organization
Koshigayaseiwa Hospital
Division name
Department of Rehabilitation
Zip code
343-0856
Address
4-25-5Yanakachou,Koshigaya-shi,Saitama
TEL
048-967-2215
nrk29980@nifty.com
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | |
| Last name | Jibiki |
Organization
Koshigayaseiwa Hospital
Division name
Department of Rehabilitation
Zip code
343-0856
Address
4-25-5Yanakachou,Koshigaya-shi,Saitama
TEL
048-967-2215
Homepage URL
nrk29980@nifty.com
Sponsor or person
Institute
Koshigayaseiwa Hospital
Institute
Department
Personal name
ManamiJibiki
Funding Source
Organization
None
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
Koshigayaseiwa Hospital
Address
4-25-5Yanakachou,Koshigaya-shi,Saitama
Tel
048-967-2215
nrk29980@nifty.com
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
| 2024 | Year | 01 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060885
