UMIN-CTR Clinical Trial

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