UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042117 |
|---|---|
| Receipt number | R000048068 |
| Scientific Title | Synergistic effect of voluntary practice program and occupational therapy after Distal radius fracture surgery |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2024/02/19 14:01:58 |
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Basic information
Public title
Synergistic effect of voluntary practice program and occupational therapy after Distal radius fracture surgery
Acronym
Synergistic effect of voluntary practice program and occupational therapy after Distal radius fracture surgery
Scientific Title
Synergistic effect of voluntary practice program and occupational therapy after Distal radius fracture surgery
Scientific Title:Acronym
Synergistic effect of voluntary practice program and occupational therapy after Distal radius fracture surgery
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify whether outpatient occupational therapy can be combined with a voluntary practice program after distal radius fracture to increase efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient-Rated Wrist Evaluation (PRWE) 6 weeks after surgery
Key secondary outcomes
wrist joint forearm range of motion, grip strength, pain (Visual Analogue Scale, pain catastrophizing scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
An occupational therapist teaches voluntary practice at the time of examination.
Interventions/Control_2
An occupational therapist teaches voluntary practice at the time of examination.
In addition to voluntary practice, occupational therapy is given 4 times in 6 weeks.
Interventions/Control_3
An occupational therapist teaches voluntary practice at the time of examination.
In addition to voluntary practice, occupational therapy is given 8 times in 6 weeks.
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
1)Subjects who underwent volar plate fusion after distal radius fracture
2)18 years old and over
3)Independence in daily life
Key exclusion criteria
If there is a fracture other than the distal radius fracture.
When it is difficult to carry out independent practice.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Sakurai |
Organization
Aizawa Hospital
Division name
Department of Orthopedic Rehabilitation Center
Zip code
390-8510
Address
2-5-1 Honjou,Matumoto-shi,Nagano 390-8510,JAPAN
TEL
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 Orthopedic Rehabilitation Center
Zip code
390-8510
Address
2-5-1 Honjou,Matumoto-shi,Nagano 390-8510,JAPAN
TEL
0263-33-8600
Homepage URL
ai.47324@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
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
Address
2-5-1 Honjou,Matumoto-shi,Nagano 390-8510,JAPAN
Tel
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
| 2021 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
https://doi.org/10.1177/17531934241231709
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1177/17531934241231709
Number of participants that the trial has enrolled
128
Results
At the 6-week evaluation, we observed a significant difference in PRWE scores among the groups. The PRWE score in group 3 was significantly better than that in group 1. The difference of 18 points (p < 0.01) corresponded to a medium effect size (r: 0.37) and sufficient power (r: 0.81) to detect differences.
Results date posted
| 2023 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Because it has not yet been adopted.
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 16 | Day |
Baseline Characteristics
The mean age of the study population was 65.1 years (SD: 15.6, range: 18-91); 79 (81%) were female; 50 (50%) were injured in the dominant hand; the mean time from injury to surgery was 5.2 days (SD: 4.5); 22 (22%) were high-energy injuries. The mean baseline PRWE score prior to injury was 1.0 (SD: 3.1), VAS pain score was 32.7 (SD: 24.0), PCS score was 21.5 (SD: 11.7), active ROM was 28 (SD: 13)% wrist flexion/extension and 46 (SD: 16)% forearm pronation/uprotation The baseline data were from a high energy injury study. All baseline data were comparable between groups except for the distribution of high-energy injuries.
Participant flow
Participants were recruited between August 2020 and April 2022 until the required number of patients was enrolled. A total of 128 distal radial fractures in 128 patients underwent anterior locking plate fixation at our institution during the study period. Of those, 102 met the inclusion criteria and were assigned to the study.
Adverse events
none
Outcome measures
Patient-Rated Wrist Evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 11 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 11 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048068
