UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046290
Receipt number R000052828
Scientific Title Intervention effect of telerehabilitaion for patients with orthopedic diseases
Date of disclosure of the study information 2022/01/01
Last modified on 2021/12/06 15:38:35

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Basic information

Public title

Intervention effect of telerehabilitaion for patients with orthopedic diseases

Acronym

Intervention effect of telerehabilitaion for patients with orthopedic diseases

Scientific Title

Intervention effect of telerehabilitaion for patients with orthopedic diseases

Scientific Title:Acronym

Intervention effect of telerehabilitaion for patients with orthopedic diseases

Region

Japan


Condition

Condition

orthopedic diseases

Classification by specialty

Orthopedics Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of the effect of implementing telerehabilitaion after discharge on improving the activity/participation in the International Classification of Functioning, Disability and Health

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Goal Attainment Scaling(GAS)

Key secondary outcomes

pain(numerical rating scale, Timed up and go test, Berg Balance Scale, FIM, Pain Catastrophizing Scale, satisfaction, fall prevention self-efficacy, Life-Space Assessment


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

telerehabilitaiton (voluntary training while watching exercise video 5 times a week for 30 minutes once) and outpatient rehabilitaiton

Interventions/Control_2

outpatient rehabilitaiton only

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

60 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Elderly who are hospitalized to orthopedic disease and undergo outpatient follow-up after discharge

Key exclusion criteria

1. If you have difficulty walking before admission, 2. If you have neuromuscular or cerebrovascular disease, 3. If you do not have the understanding and cooperation of the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Tomoya
Middle name
Last name Kishimoto

Organization

Kawasaki University of Medical Welfare

Division name

Department of Physical Therapy

Zip code

701-0193

Address

288, Matsushima, Kurashiki Okayama 701-0193, Japan

TEL

086-462-1111

Email

t-kishi@mw.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name Tomoya
Middle name
Last name Kishimoto

Organization

Kawasaki University of Medical Welfare

Division name

Department of Physical Therapy

Zip code

701-0193

Address

288, Matsushima, Kurashiki Okayama 701-0193, Japan

TEL

086-462-1111

Homepage URL


Email

t-kishi@mw.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki University of Medical Welfare

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical corporation Nijinkai Ishikawa Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawasaki University of Medical Welfare

Address

288, Matsushima, Kurashiki Okayama 701-0193, Japan

Tel

09052621579

Email

t-kishi@mw.kawasaki-m.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

2022 Year 01 Month 01 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

19

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

No longer recruiting

Date of protocol fixation

2021 Year 04 Month 01 Day

Date of IRB

2021 Year 01 Month 14 Day

Anticipated trial start date

2022 Year 01 Month 01 Day

Last follow-up date

2023 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 12 Month 06 Day

Last modified on

2021 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052828