UMIN-CTR Clinical Trial

Basic information
Public title	Effects of tele-rehabilitation for after discharge patients with hip fracture
Acronym	Effects of tele-rehabilitation for patients with hip fracture
Scientific Title	Effects of tele-occupational therapy for after discharge clients with hip fracture
Scientific Title:Acronym	Effect of tele-occupational therapy for clients with hip fracture
Region	Japan

Condition
Condition	Hip fracture
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identify the effects of tele-occupational therapy to clients with hip fracture in Japan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EuroQolS-Dimension Functional Independence Measure Occupational Self Assessment -Short Form Physical Activity Scale for Elderly Care Requiring
Key secondary outcomes	Numeric Rating Scale Range of motion Manual Muscle Test Timed Up & Go Test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group Training that promotes the acquisition of specific executive skills to achieve specific goals, ADL training, education for hip fractures
Interventions/Control_2	Control group Jigsaw puzzle Study period: 3 months (One intervention per week)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with hip fracture and have been discharged at home. Inclusion criteria: Whose patients or caregiver Agree this study, and whose general symptoms are stable.
Key exclusion criteria	A person with dementia or higher brain dysfunction.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Daichi Middle name Last name Nitta
Organization	Kushiro Red cross hospital
Division name	Department of Rehabilitation
Zip code	0858512
Address	21-14 Shinei-cho, Kushiro-city, Hokkaido 085-8512, Japan
TEL	0154-22-7171
Email	nittakumano@gmail.com

Public contact
Name of contact person	1st name daichi Middle name Last name nitta
Organization	Kibi International University Graduate School
Division name	Division of Health Sciences
Zip code	7168508
Address	8 Iga-cho, Takahashi City, Okayama Prefecture, 716-8508, Japan
TEL	0866229454
Homepage URL
Email	nittakumano@gmail.com

Sponsor
Institute	Kibi International University Graduate School
Institute
Department

Funding Source
Organization	None
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	International University Graduate School
Address	8 Iga-cho, Takahashi City, Okayama Prefecture, 716-8508, Japan
Tel	0866-22-9454
Email	nittakumano@gmail.com

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	2023 Year 04 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
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	2022 Year 01 Month 03 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 03 Day
Last follow-up date	2022 Year 11 Month 30 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 20 Day
Last modified on	2021 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052968