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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039194
Receipt No. R000044696
Scientific Title Study on intervention using Stress Loading Program for patients with distal radius fracture
Date of disclosure of the study information 2020/01/23
Last modified on 2020/01/18

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Basic information
Public title Study on intervention using Stress Loading Program for patients with distal radius fracture
Acronym Study on intervention using Stress Loading Program for patients with distal radius fracture
Scientific Title Study on intervention using Stress Loading Program for patients with distal radius fracture
Scientific Title:Acronym Study on intervention using Stress Loading Program for patients with distal radius fracture
Region
Japan

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

Objectives
Narrative objectives1 We investigated the effects of range of motion, fear of falling, frequency of hand use in daily life, pain, grip strength, and standing time for one leg when we conducted the Stress Loading Program for patients with distal radius fractures .
In addition, the relationship between the standing posture and the body sway, fall history, and injury rotation during the Stress Loading Program is also examined using a body sway meter.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fear of falling
Measure initial assessment 8 weeks after surgery and final assessment 10 weeks after surgery
Key secondary outcomes Fracture classification , fall history , injury mechanism ,Range of motion , hand use in daily life (DASH) , pain (PRWE) , grip strength , single leg standing , stabilometer , WHO fracture risk assessment tool FRAX
Measure initial assessment 8 weeks after surgery and final assessment 10 weeks after surgery
Six months later, one year later , a follow-up survey will be conducted to determine if a fall occurred.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention according to our protocol for distal radius fracture.
In addition, the intervention byStress Loading Program
Duration: 2 weeks, frequency ofoutpatient occupational therapy2-3 times a week
Six months later, one year later , a follow-up survey will be conducted to determine if a fall occurred.
Interventions/Control_2 Intervention according to our protocol for distal radius fracture.
Duration: 2 weeks, frequency of outpatient occupational therapy 2-3 times a week .
Six months later, one year later , a follow-up survey will be conducted to determine if a fall occurred.
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
90 years-old >
Gender Female
Key inclusion criteria Patient who was prescribed occupational therapy for diagnosis of distal radius fracture at our hospital
Key exclusion criteria 1.Patients with a history of cerebrovascular disease and lower limb orthopedic disease
2.Patients with a fracture in theupper limb other than the distal radius fracture
3.Patients with cognitive dysfunction who have difficulty understanding language
4.Patient in which the doctor cannot give instructions on the load due to severe fracture
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Kimura
Organization Isogo Central Hospital
Division name Department of Rehabilitation
Zip code 235-0016
Address 2-20-45 Isogo , Isogo Ward Yok ohama-city Kanagawa
TEL 045-752-1212
Email ryota151@infoseek.jp

Public contact
Name of contact person
1st name Kimura
Middle name
Last name Ryota
Organization Isogo Central Hospital
Division name Department of Rehabilitation
Zip code 235-0016
Address 2-20-45 Isogo , Isogo Ward Yok ohama-city Kanagawa
TEL 045-752-1212
Homepage URL
Email ryota151@infoseek.jp

Sponsor
Institute Isogo Central Hospital
Department of Rehabilitation
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanagawa University of Human Services
Name of secondary funder(s)

IRB Contact (For public release)
Organization Isogo Central Hospital
Address 2-20-45 Isogo , Isogo Ward Yok ohama-city Kanagawa
Tel 045-752-1212
Email ryota151@infoseek.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 磯子中央病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 23 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
2020 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2021 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
2020 Year 01 Month 18 Day
Last modified on
2020 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044696

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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