UMIN-ICDS Clinical Trial

Public title

An exploratory interventional study of a mixed reality game integrating assessment and treatment for children and adults with upper limb motor impairment due to central nervous system disorders.

Acronym

An exploratory interventional study of a mixed reality game integrating assessment and treatment for upper limb motor impairment

Scientific Title

An exploratory interventional study of a mixed reality game integrating assessment and treatment for children and adults with upper limb motor impairment due to central nervous system disorders

Scientific Title:Acronym

An exploratory interventional study of a mixed reality game integrating assessment and treatment for upper limb motor impairment

Region

Japan

Condition

central nervous system disorders

Classification by specialty

Neurology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to assess the feasibility and explore the efficacy of a mixed reality (MR) game integrating assessment and treatment in children and adults with upper limb motor impairment due to central nervous system disorders.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

) Questionnaire-based assessment of the system
- Adult patients (aged 18 years or older): Quebec User Evaluation of Satisfaction with Assistive Technology, version 2.0 (QUEST 2.0); System Usability Scale (SUS); a brief questionnaire assessing enjoyment, willingness to play again, perceived difficulty, fatigue, and the absence of pain or nausea, with each item rated on a visual analogue scale (VAS); and Simulator Sickness Questionnaire (SSQ).
- Pediatric patients: A brief questionnaire assessing enjoyment, willingness to play again, perceived difficulty, fatigue, and the absence of pain or nausea, with each item rated on a visual analogue scale (VAS); and Simulator Sickness Questionnaire (SSQ).
2) Kinematic assessment of the paretic upper limb
Upper limb movements will be recorded using markerless motion capture.
Secondary outcome measures (including metrics and assessment methods)
- Ophthalmological assessment: Distance and near visual acuity, refraction, ocular alignment, binocular visual function, accommodative function, convergence and divergence, subjective symptoms (asthenopia, diplopia, blurred vision, ocular pain, headache, dizziness, and nausea), anterior segment and fundus findings, and ocular axial length.
- Data obtained from in-game logs: Task completion rate, gameplay duration, error rate, and other recorded variables.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Children and adults with upper limb motor impairment due to central nervous system disorders will participate in a game integrating assessment and treatment while wearing a mixed reality device at Keio University Hospital. The intervention will be delivered for approximately 30 minutes per day on a total of 10 intervention days, which need not be consecutive. Intervention days will be scheduled according to participants' health and hospital attendance. Upper limb movement data and game performance will be recorded, and tasks will be presented at difficulty levels appropriate to each participant's motor ability. Upper limb function and ophthalmological assessments will be performed before the first intervention and after the intervention on the tenth intervention day. The Simulator Sickness Questionnaire and a brief questionnaire will be administered after the first intervention. Participants aged 18 years or older will also complete QUEST 2.0 and the System Usability Scale. If the SSQ total score after the first intervention exceeds 40, continuation will be determined in consultation with the principal investigator and subinvestigators, based on the nature and severity of symptoms. Participants deemed able to continue will proceed to subsequent intervention days, with adverse events assessed and recorded before and after each intervention from the second intervention day onward.

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

Age-lower limit

6

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Aged 6 years or older.
2. Upper limb paresis due to a central nervous system disorder.
3. At least 90 days have elapsed since the onset of the central nervous system disorder.

Key exclusion criteria

Missing data.
Difficulty maintaining a sitting position.
Upper limb disorders other than paresis of central origin (e.g., upper limb fractures).
Communication difficulties due to aphasia or impaired consciousness.
Severe impairment of higher brain functions that makes assessment difficult.
Severe visual or hearing impairment.
Severe psychiatric disorders, such as depression or schizophrenia.
Contraindications to exercise therapy, as detailed below:
-Severe cardiac disease, including unstable angina, recent myocardial infarction, decompensated congestive heart failure, acute cor pulmonale, poorly controlled arrhythmias, severe aortic stenosis, active myocarditis, or endocarditis.
-Poorly controlled hypertension.
-Acute systemic illness or fever.
-Recent pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension.
-Severe hepatic or renal dysfunction.
-Severe orthopedic conditions that interfere with exercise.
-Severe cognitive impairment or severe psychiatric disorders.
-Other metabolic abnormalities (e.g., acute thyroiditis).

Target sample size

50

Name of lead principal investigator

1st name	Michiyuki
Middle name
Last name	Kawakami

Organization

Keio University

Division name

Department of Rehabilitation Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-5843-6169

Email

daisuke.ito@keio.jp

Name of contact person

1st name	Daisuke
Middle name
Last name	Ito

Organization

Keio University

Division name

Department of Rehabilitation Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-5843-6169

Homepage URL

Email

daisuke.ito@keio.jp

Institute

Keio University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Keio University

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-5363-3611

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

28

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

28

Day

Last modified on

2026

Year

10

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072612