UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000060861
Receipt number R000068833
Scientific Title A Study on the Effects of Sensor Games on Physical Fitness Among Users of Daily Living Support Facilities
Date of disclosure of the study information 2026/03/06
Last modified on 2026/03/06 22:40:41

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Basic information

Public title

A Study on the Effects of Sensor Games on Physical Fitness Among Users of Daily Living Support Facilities

Acronym

A Study on the Effects of Sensor Games on Physical Fitness Among Users of Daily Living Support Facilities

Scientific Title

A Study on the Effects of Sensor Games on Physical Fitness Among Users of Daily Living Support Facilities

Scientific Title:Acronym

A Study on the Effects of Sensor Games on Physical Fitness Among Users of Daily Living Support Facilities

Region

Japan


Condition

Condition

Individuals attending a daily living support facility

Classification by specialty

Orthopedics Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate the effects of a whole-body exercise intervention using sensor games on physical functions such as standing-to-sitting ability, walking ability, and balance ability in users attending a daily living care facility. This evaluation will be conducted before and after a 4-week intervention period to assess its safety and feasibility.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Timed UP and Go test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Exercise through sensor games

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Age at consent acquisition: 18 years or older and 80 years or younger
Individuals currently attending a daily living support facility
Individuals who have consented to participate in this research

Key exclusion criteria

Individuals with difficulty communicating verbally
Individuals who have previously performed DigiReha sensor games at least four times per month
Individuals with walking difficulties who cannot perform the Timed Up and Go test

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Yasuaki
Middle name
Last name Kusumoto

Organization

Fukushima Medical University School of Health Sciences

Division name

Department of Physical Therapy

Zip code

960-8516

Address

10-6 Sakaemachi, Fukushima city, Fukushima

TEL

0245815503

Email

kusumoto@fmu.ac.jp


Public contact

Name of contact person

1st name Yasuaki
Middle name
Last name Kusumoto

Organization

Fukushima Medical University School of Health Sciences

Division name

Department of Physical Therapy

Zip code

960-8516

Address

10-6 Sakaemachi, Fukushima city, Fukushima

TEL

0245815503

Homepage URL


Email

kusumoto@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University School of Health Sciences

Institute

Department

Personal name

Kusumoto Yasuaki


Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukushima Medical University Ethics Review Committee

Address

Hikarigaoka 1, Fukushima City, Fukushima Prefecture

Tel

0245815503

Email

fmurec@fmu.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

福島県


Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2026 Year 03 Month 06 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

2025 Year 12 Month 22 Day

Date of IRB

2025 Year 12 Month 22 Day

Anticipated trial start date

2025 Year 12 Month 22 Day

Last follow-up date

2027 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

2026 Year 03 Month 06 Day

Last modified on

2026 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068833