UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058317 |
|---|---|
| Receipt number | R000066672 |
| Scientific Title | A Randomized Controlled Trial of Dynamic Flamingo exercise in Postoperative Patients with Distal Radius Fractures |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/07/12 15:56:41 |
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Basic information
Public title
A Randomized Controlled Trial of Dynamic Flamingo exercise in Postoperative Patients with Distal Radius Fractures
Acronym
Randomized controlled trial incorporating balance exercise in postoperative patients with distal radius fracture fractures
Scientific Title
A Randomized Controlled Trial of Dynamic Flamingo exercise in Postoperative Patients with Distal Radius Fractures
Scientific Title:Acronym
A Randomized Controlled Trial of Dynamic Flamingo exercise 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
This study will determine whether dynamic flamingo exercise (balance exercises) as an intervention improves balance and walking ability immediately after distal radius fracture surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation at 6 weeks, 12 weeks, 6 months, and 1 year postoperatively
Timed Up and Go Test(TUG)
Key secondary outcomes
Evaluated at 6, 12, 6 months, and 1 year postoperatively
Range of motion, grip strength, Patient-Rated Wrist Evaluation(PRWE), one leg standing time, EQ5D5L, TSK-j
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
In addition to regular independent practice, dynamic flamingo practice (balance practice) will be conducted three times a day for six weeks.
Interventions/Control_2
A regular voluntary practice program will be implemented three times a day for six weeks.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient over 50 years of age who sustained a distal radius fracture due to a fall and underwent palmar plate fixation.
Key exclusion criteria
Patients with multiple traumas and bilateral upper extremity fractures that make it difficult to assess treatment outcome.
Patients with paralysis, neurological impairment, or cognitive decline that makes it difficult to assess treatment outcome.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Sakurai |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Rehabilitation
Zip code
390-8510
Address
Honjo 1-5-2, Matsumoto
TEL
81-0263-33-8600
ai.47324@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Sakurai |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Rehabilitation
Zip code
390-8510
Address
Honjo 1-5-2, Matsumoto
TEL
81-0263-33-8600
Homepage URL
ai.47324@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Toshiyasu Sakurai
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
Aizawa Hospital Clinical Research Ethics Committee
Address
Honjo 1-5-2, Matsumoto 390-8510, Japan
Tel
81-0263-33-8600
kenkuy@hosp.or.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
| 2025 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066672
