UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039194 |
|---|---|
| Receipt number | 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 18:27:58 |
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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
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
ryota151@infoseek.jp
Sponsor or person
Institute
Isogo Central Hospital
Department of Rehabilitation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044696
