UMIN-CTR Clinical Trial

Basic information
Public title	Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Acronym	Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Scientific Title	Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Scientific Title:Acronym	Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Region	Japan

Condition
Condition	Total knee arthroplasty/Total hip arthroplasty
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effectiveness and feasibility of post-discharge telerehabilitation on the inprovement of physical function
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Timed up and go test/six minutes walking test
Key secondary outcomes	pain(numerical rating scale, Pain Catastrophizing Scale, satisfaction, pain self-efficacy questionnaire, Life-Space Assessment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom Maneuver
Interventions/Control_1	telerehabilitaiton (voluntary training while watching exercise video 5 times a week for 30 minutes once) and outpatient rehabilitaiton onece for week
Interventions/Control_2	outpatient rehabilitaiton only (onece for 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	50 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Elderly who are hospitalized to initial TKA or THA 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
Institute	Kawasaki University of Medical Welfare
Institute
Department

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 02 Month 05 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	60
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 12 Month 01 Day
Date of IRB	2021 Year 01 Month 14 Day
Anticipated trial start date	2022 Year 02 Month 15 Day
Last follow-up date	2022 Year 12 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	2022 Year 02 Month 03 Day
Last modified on	2022 Year 12 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053415