UMIN-CTR Clinical Trial

Basic information
Public title	The study on the usefulness of rehabilitation using smartphone apps for patients after wrist surgery
Acronym	Examination of rehabilitation effect by smartphone apps
Scientific Title	The study on the usefulness of rehabilitation using smartphone apps for patients after wrist surgery
Scientific Title:Acronym	Examination of rehabilitation effect by smartphone apps
Region	Japan

Condition
Condition	Distal Radius Fracture, Carpal tunnel syndrome
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of smartphone apps for rehabillitaition
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	DASH-JSSH at 12 weeks postoperatively
Key secondary outcomes	DASH-JSSH, Grip strength, range of wrist motion at 4,6,8,10,27 weeks postoperatively,

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Using smartphone apps 10 minutes everyday, from 3-12 weeks postoperatively
Interventions/Control_2
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	The patients with distal radius fracture or carpal tunnel syndrome who underwent surgeries.
Key exclusion criteria	Patients who are < 20 years of age. Can't use smartphone by themselves. are with Dementia, mental disease which prevent from understanding the research. are suffering from traffic accident or labor injury. have another fracture or illness on their upper extremities.
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Fujita
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic and Spinal Surgery
Zip code	113-8519
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5279
Email	fujiorth@tmd.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Fujita
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic and Spinal Surgery
Zip code	1138519
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5279
Homepage URL
Email	fujiorth@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Internal funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima Bunkyo-ku
Tel	+81358035279
Email	fujiorth@tmd.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 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	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2023 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	2016 Year 12 Month 30 Day
Last modified on	2020 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029326