UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027451
Receipt number R000031375
Scientific Title The effect of rehabilitation on brain function and fracture risk in elderly with fractures.
Date of disclosure of the study information 2017/06/05
Last modified on 2022/11/28 19:48:40

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Basic information

Public title

The effect of rehabilitation on brain function and fracture risk in elderly with fractures.

Acronym

The effect of rehabilitation on brain function and fracture risk in elderly with fractures.

Scientific Title

The effect of rehabilitation on brain function and fracture risk in elderly with fractures.

Scientific Title:Acronym

The effect of rehabilitation on brain function and fracture risk in elderly with fractures.

Region

Japan


Condition

Condition

fractures

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to prevent decrease in quality of life in elderly with fractures, we will consider whether combination use of OT in addition to PT is effective

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of changes in brain functions between hospitalization and discharge before departure, depending on the type of rehabilitation.

Key secondary outcomes

Comparison of changes in blood pentosidine at hospitalization and before discharge from the type of rehabilitation.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Rehabilitation will be conducted 120 minutes a day (PT 60 minutes and OT 60 minutes) every day from the day after hospitalization to discharge to the study subject.

Interventions/Control_2

Rehabilitation for PT 120 minutes a day for each day from hospitalization day to hospitalization for the subjects.

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

65 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients scheduled for rehabilitation only for PT in regular practice.
2)Elderly people over 65 years old in spinal vertebral fractures due to falls.
3)Elderly people over 65 years old who have fractured proximal femur due to falls.
4)Patients requiring hospitalization for more than one month.

Key exclusion criteria

1)Patients who broke with strong external force.
2)Patients with severe complications other than fractures.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Katsuya
Middle name
Last name Urakami

Organization

Tottori University Factory of Medicine School of Health Sciences

Division name

Department of Biological Regulation

Zip code

683-8504

Address

86 Nishi-cho,Yonago-shi,Tottori-ken

TEL

0859-38-6354

Email

kurakami@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Mitsubishi

Organization

Tottori University Factory of Medicine School of Health Sciences

Division name

Department of Biological Regulation

Zip code

683-8504

Address

86 Nishi-cho,Yonago-shi,Tottori-ken

TEL

0859-38-6354

Homepage URL


Email

macchanyann@yahoo.co.jp


Sponsor or person

Institute

Tottori University Factory of Medicine School of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

No

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

Tottori University Factory of Medicine School of Health Sciences Department of Biological Regulation

Address

86 Nishi-cho,Yonago-shi,Tottori-ken

Tel

0859-38-6354

Email

kurakami@med.tottori-u.ac.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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 05 Day


Related information

URL releasing protocol

https://www.karger.com/Article/FullText/495937

Publication of results

Published


Result

URL related to results and publications

https://www.karger.com/Article/FullText/495937

Number of participants that the trial has enrolled

28

Results

Changes in TDAS scores and serum pentosidine levels did not differ significantly between the 2 therapies. Power spectral analysis revealed a significant intergroup difference in
delta waves. Coherence analysis showed significant intergroup differences in the activities of delta waves and beta waves.

Results date posted

2022 Year 11 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 02 Month 07 Day

Baseline Characteristics

We investigated how the type of rehabilitation affects brain function and antioxidant potential.

Participant flow

Twenty-eight patients hospitalized for fall-related fractures were assigned to either a physical therapy group or an occupational therapy group.

Adverse events

None

Outcome measures

Cognition was assessed using the Touch Panel-type Dementia Assessment Scale (TDAS) and oxidative stress with serum pentosidine levels. Spectral analysis and coherence analysis were also performed.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 05 Month 02 Day

Date of IRB

2017 Year 05 Month 23 Day

Anticipated trial start date

2017 Year 06 Month 05 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 04 Month 01 Day

Date analysis concluded

2018 Year 09 Month 20 Day


Other

Other related information



Management information

Registered date

2017 Year 05 Month 22 Day

Last modified on

2022 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031375


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name