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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015003
Receipt No. R000017448
Scientific Title Efficacy of Occupational Therapy after Volar Locking Plate Fixation of the Distal Radius Fracture: A Randomized Controlled Trial
Date of disclosure of the study information 2014/08/31
Last modified on 2019/03/07

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Basic information
Public title Efficacy of Occupational Therapy after Volar Locking Plate Fixation of the Distal Radius Fracture: A Randomized Controlled Trial
Acronym Efficacy of OT after Operation of DRF
Scientific Title Efficacy of Occupational Therapy after Volar Locking Plate Fixation of the Distal Radius Fracture: A Randomized Controlled Trial
Scientific Title:Acronym Efficacy of OT after Operation of DRF
Region
Japan

Condition
Condition Distal radius fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of occupationa therapy after volar locking plate fixation of distal radius fracture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quick Disability of Arm, Shoulder, and Hand (QuickDASH) score after 6 weeks
Key secondary outcomes Range of motion of the wrist and the forearm, Grip strength, Pinch strength, Patient-Rated Wrist Evaluation (PRWE), Pain evaluated by Visual Analogue Scale(VAS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Occupational therapy (2 times/week, during the twelve weeks after surgery) and home exercise instruction by the attending doctor at every visit.
Interventions/Control_2 Home exercise instruction by the attending doctor at every visit.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Patients who have a distal radius fracture to open reduction and internal fixation with volar locking plate.
2) Patients 40 years of age or over at the time of providing consent.
3) Patients who could provide written consent for participation.
Key exclusion criteria 1) Patients with a history of a distal radius fracture.
2) Patients with complex regional pain syndrome.
3) Patients with a connective tissue disease.
4) Patients who are deemed unsuitable by the attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazushige Gamo
Organization Bellland General Hospital
Division name Orthopaedic Surgery
Zip code
Address 500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka 599-8247, Japan
TEL 072-234-2001
Email kaz-gamo@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazushige Gamo
Organization Bellland General Hospital
Division name Orthopaedic Surgery
Zip code
Address 500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka 599-8247, Japan
TEL 072-234-2001
Homepage URL
Email kaz-gamo@umin.ac.jp

Sponsor
Institute Bellland General Hospital
Institute
Department

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
Address
Tel
Email

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 ベルランド総合病院 

Other administrative information
Date of disclosure of the study information
2014 Year 08 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
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 No longer recruiting
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 31 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017448

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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