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

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 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

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

Value
https://center6.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