UMIN-CTR Clinical Trial

Public title

HoloLens2 and Mixed Reality Assessment of Ocular Motility While Catching and Throwing Balls

Acronym

Ball activity therapy with Hololens2 for developmental disabilities

Scientific Title

Identifying Ocular Patterns in Children with Developmental Disabilities During Catching and Throwing Activity

Scientific Title:Acronym

Identifying Ocular Patterns in Children with Developmental Disabilities

Region

Japan

Condition

People with Developmental Disabilities, ASD, DCD, or ADHD

Classification by specialty

Rehabilitation medicine

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aims of this study were (1) to investigate eye gaze patterns of persons with ball sports experience, based on virtual augmentation during overhead target throwing and playing catch, and (2) to investigate the usability of the Mixed reality system for motor skills training through throwing and catching activities.
We used the Mixed Reality Tool Kit (MRTK) system, in which we combined a HoloLens2 smart glasses (Microsoft Corporation) with a motion recording capture system.
The MRTK system has the potential to provide motor skills training and to assess the eye movement pattern outside of the clinic. This initial investigation of mixed reality (MR) motor skills training may aid in the development of not only motor skills, but also social skills such as eye contacts and reading facial expression with all children, including those with developmental disabilities.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

There are two trials we are going to investigate. The first trial was the target throwing task during which each subject was wearing a HoloLens2 to view the virtual target and was allowed 10 throws to try to hit them. The second trial was the playing catch task, which required each subject to throw and catch a ball 10 times. All trials were recorded with HoloLens2 to gather eye gaze data, and digital video cameras to gather skilled movement data. The subjects' eye tracking patterns, as well as the usability and safety of the HoloLens2 in motor skills training, were evaluated.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

People with Developmental Coordination Disabilities, ASD, or other Developmental Disabilities.
The first trial was the target throwing task during which each subject was wearing a HoloLens2 to view the virtual target and was allowed 10 throws to try to hit them. The second trial was the playing catch task, which required each subject to throw and catch a ball 10 times. All trials were recorded with HoloLens2 to gather eye gaze data, and digital video cameras to gather skilled movement data.

Interventions/Control_2

Contarl group who have never diagnose with any Developmental Disabilities and There are no limitation to participate to the Physical activities.
The first trial was the target throwing task during which each subject was wearing a HoloLens2 to view the virtual target and was allowed 10 throws to try to hit them. The second trial was the playing catch task, which required each subject to throw and catch a ball 10 times. All trials were recorded with HoloLens2 to gather eye gaze data, and digital video cameras to gather skilled movement data.

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

12

years-old

>=

Gender

Male and Female

Key inclusion criteria

Criterias of Subject
1-1. Groups with Developmental Disabilities
1) Patients diagnosed with developmental disabilities include developmental coordination disorder, autism spectrum disorder and others.
2) Those who are enrolled in the Gunma university Special Needs School or the Counseling and Support Office Hidamari.
3) Age is 6 to 12 years old.
4) Gender is not required
5) The person is in a state where he can understand instructions and is in a state where he can perform movements.
6) Subject is possible to maintain the posture for 1 hour in a walking or standing.
7) Informed ascent has been obtained from the researcher himself / herself for participation in this study, and written consent has been obtained from the substitute.
1-2. Contrl group
1) They range in age from 6 to 12 years.
2) Students must be enrolled in a regular class at Gunma University Elementary School or Numata Kita Elementary School.
3) Those who have no physical disabilities and can perform exercise including physical education classes without restrictions.
4) Gender is not required
5) Never been diagnosed with developmental coordination disorder or autism spectrum disorder, and have never had symptoms of developmental disabilities including these disorders.
6) Informed ascent has been obtained from the researcher himself / herself regarding participation in this research, and consent has been obtained in writing from the substitute.

Key exclusion criteria

Exclusion Criteria
2-1. Groups with Developmental Disabilities
1) Patients with neurological diseases.
2) Patients with head injury.
3) Patients with obvious impairment of consciousness.
4) Visual impairment, patients with visual field defects.
5) Visual acuity in both eyes is 0.6 or less.
6) Those who use certain types of contact lenses or glasses that are not supported by the HoloLens 2 system.
7) In addition, it was judged to be inappropriate as a subject based on the judgment of the researcher.
2-2. Control group
1) Neurological diseases such as brain or spinal cord.
2) Have a mental illness.
3) Have a head injury.
4) Have obvious impaired consciousness.
5) Developmental disabilities.
6) Visual impairment, with visual field defects.
7) Visual acuity in both eyes is 0.6 or less.
8) Those who use certain types of contact lenses or glasses that are not supported by the HoloLens 2 system.
9) In addition, the researchers judged the subjects to be inappropriate.

Target sample size

40

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Wada

Organization

Gunma University Medical School Hospital

Division name

Rehabilitation Medicine

Zip code

371-8511

Address

3-39-22 Showa-machi Maebashi-shi, Gunma Japan

TEL

027-220-8655

Email

nwada@gunma-u.ac.jp

Name of contact person

1st name	Masayuki
Middle name
Last name	Tazawa

Organization

Gunma University Medical School Hospital

Division name

Rehabilitation Medicine

Zip code

371-8511

Address

3-39-22 Showa-machi Maebashi-shi, Gunma Japan

TEL

027-220-8655

Homepage URL

Email

reha-dr@ml.gunma-u.ac.jp

Institute

Gunma University

Institute

Department

Personal name

Organization

Gunma Univesity

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma University

Address

3-39-22 Showa-machi Maebashi, Gunma Japan

Tel

027-220-8655

Email

hitotaisho-ciru@ml.gunma-u.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

群馬大学大学院医学系研究科リハビリテーション科、群馬大学共同教育学部附属特別支援学校，相談支援事業所ひだまり，群馬大学共同教育学部附属小学校，沼田市立沼田北小学校

Date of disclosure of the study information

2023

Year

02

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

40

Results

Results: Children with DD had a longer QE duration during the Target Throw trial using MR, and they tended to have sufficient motor control skills to release the ball during activity with MR (QE at Target Throw DD vs. Playing Catch DD: MD=0.6365, SE=0.19311, p=0.008).

Results date posted

2024

Year

08

Month

05

Day

Results Delayed

Delay expected

Results Delay Reason

Submitted to a medical journal, awaiting review results.

Date of the first journal publication of results

Baseline Characteristics

The study included 40 participants, who were children of 7 to 12 years of age. Among these children, 20 were diagnosed with DD by a pediatrician: 17 male; 3 female; mean age, 8.8 years, SD 0.95, and showed typical development: TD; 17 male; 3 female; mean age, 9.05 years; SD 1.69. Children with DD were recruited from special needs schools in Saitama and Gunma Prefectures in Japan. Participants were required to be able to understand the instruction, have a good general condition, and a stable mental state. They had to maintain good posture while walking or standing for 1 hour as part of their physical activity participation requirements.

Participant flow

Target Throw Assignment
In the Target Throw trials, participants were instructed to capture and throw balls at holograms displayed in mixed reality using their focused gaze. The distance to the target was set at approximately 5 m. The light balls were thrown 5 times, and the heavy balls were thrown 5 times. The participants were instructed to aim carefully and throw the ball under the guidance of the hologram. The recognition of success was based on the participant focusing on the target for at least 100 ms and hitting the intended target.

Playing Catch Assignment
In the Playing Catch trials, each participant played catch with the researcher while wearing HoloLens 2. The participants stood straight ahead of their opponent and threw a ball toward the researcher. Assuming a distance from the opponent of approximately 5 m, participants performed 5 throws each with a light ball and a heavy ball.

Adverse events

none

Outcome measures

Gaze Behavior
The participants wore the wearable mixed reality device, securely adjusting it on their heads to ensure that the eyelid shape and pupil movements were accurately recorded for eye gaze measurements. After confirming proper device placement and adjustments, participants were instructed to fixate on the hologram before throwing. The trial was considered successful if the fixation lasted for at least 100 ms as fixed vision.

Performance
The outcome of throwing performance was expressed as a percentage of each trial where the participant successfully hit the hologram target or accurately thrown the ball to the opponent with a controlled vision score. In each trial, success rates for hitting the target and proficiency in fine motor skills were compared between the light and heavy balls in the DD and TD groups.

QE
The onset of QE was defined as the final fixation: approximately 30 cm size of the virtual target and the opponent in front of the participant, before the onset of the fore-swing of the throwing arm. The offset of the QE was defined as the gaze deviating from the target location by more than 1.5 degrees for longer than 100 ms. The duration of QE was the time between the onset and offset of QE. We only measured the trials for which the target was successfully tracked within 1.5 degrees for longer than 100ms.

Release time
The release time was defined as the duration from final eye fixation to ball release. The RT measured the time required for a series of movements, starting from focusing on the target, entering the throwing action, losing focus, swinging the arm, and releasing the ball.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

02

Month

02

Day

Date of IRB

2022

Year

12

Month

21

Day

Anticipated trial start date

2023

Year

02

Month

02

Day

Last follow-up date

2024

Year

01

Month

10

Day

Date of closure to data entry

2024

Year

01

Month

10

Day

Date trial data considered complete

2024

Year

01

Month

10

Day

Date analysis concluded

2024

Year

05

Month

01

Day

Other related information

As of June 2023, experiments were conducted on 36 participants from among the participants who agreed to participate in the ball activity using the MR system. The target number of participants is 40, and the experiment will be continued after limited recruitment based on the research plan.

Registered date

2023

Year

02

Month

02

Day

Last modified on

2025

Year

08

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057135