UMIN-CTR Clinical Trial

Basic information
Public title	Effect of group rehabilitation on quality of life for people requiring nursing care
Acronym	Effect of group rehabilitation on quality of life for people requiring nursing care
Scientific Title	Effect of group rehabilitation on quality of life for people requiring nursing care
Scientific Title:Acronym	Effect of group rehabilitation on quality of life for people requiring nursing care
Region	Japan

Condition
Condition	The general public
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effects of group rehabilitation on the quality of life of day-care center users by providing interventions that take into account the characteristics of the users, such as their orientation toward social comparison and their emotions, which are advantages of group rehabilitation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Collection of basic information Assessment of nave function Activities of daily living and practical activities of daily living Degree of social interaction with humans Quality of life Peel off the cover Orientation to social comparison) Emotions associated with social comparison
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Users who are in daycare and require nursing care and are able to walk independently or under supervision. Those who are able to complete the questionnaire. Users who can continue to use the service for at least three months. If you have any questions, please contact us. Users who can understand and sign a written consent form.
Key exclusion criteria	Patients for whom it is difficult to conduct the assessment of walking ability. Those who have difficulty in answering all the questionnaire assessments. Those who have difficulty in continuing to use the day-care service for 3 months.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Mikami
Organization	Corporation Full Life Rehabilitation Fitness Full Life
Division name	General Nursing Department
Zip code	5720005
Address	1-29, Naruta-cho, Neyagawa-city, Osaka.
TEL	0728138000
Email	kawaguchi.ns.reha@gmail.com

Public contact
Name of contact person	1st name Atsushi Middle name Last name Mikami
Organization	Corporation Full Life Rehabilitation Fitness Full Life
Division name	General Nursing Department
Zip code	5720005
Address	1-29, Naruta-cho, Neyagawa-city, Osaka.
TEL	0728138000
Homepage URL
Email	kawaguchi.ns.reha@gmail.com

Sponsor
Institute	Corporation Full Life Rehabilitation Fitness Full Life
Institute
Department

Funding Source
Organization	None
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	Kawaguchi Neurosurgery Rehabilitation Clinic
Address	rehabilitation department
Tel	0728351010
Email	kawaguchi.ns.reha@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	2021 Year 10 Month 16 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 16 Day
Date of IRB	2021 Year 10 Month 15 Day
Anticipated trial start date	2021 Year 10 Month 16 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	None

Management information
Registered date	2021 Year 10 Month 16 Day
Last modified on	2021 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052255