Intellectual DisabilityNCT07844525
Virtual Reality Task-Oriented Physical Activity in Adults With Mental Disabilities
A study testing Virtual Reality Task-Oriented Physical Activity Training in people with Intellectual Disability and Serious Mental Illness, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
The goal of this clinical study was to examine the effects of virtual reality task-oriented physical activity on physical and task performance and brain activity in adults with mental disabilities. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intellectual Disability, Serious Mental Illness
- What is being tested?
- Virtual Reality Task-Oriented Physical Activity Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2024to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years or older.
- Had a Category I disability certification and a medical diagnosis of intellectual disability or persistent severe mental illness.
- Diagnosis of intellectual disability or persistent severe mental illness for more than 1 year.
- Mini-Mental State Examination (MMSE) score greater than 18.
- Able to understand and follow verbal instructions and cooperate with the training and assessment procedures.
- Able to walk independently for at least 10 meters without an assistive device.
Show all 9Show fewer
- Able to stand independently for at least 3 minutes without an assistive device or physical assistance and without falling.
- No stroke or other systemic chronic disease within the previous 6 months.
- No musculoskeletal injury within the previous 6 months that resulted in substantial cognitive or motor impairment.
Who cannot join
- Stroke or brain injury within the previous 6 months.
- Severe systemic disease, such as severe diabetes or heart disease, that substantially affected daily functioning.
- Mini-Mental State Examination (MMSE) score of 18 or lower.
- Unable to follow verbal instructions.
- Unable to cooperate with the training or assessment procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Virtual Reality Task-Oriented Physical Activities on Physical Function and Brain Reorganization in Adults With Mental Disabilities
The goal of this clinical study was to examine the effects of virtual reality task-oriented physical activity on physical and task performance and brain activity in adults with mental disabilities. The main questions it aimed to answer were:
- Does participation in virtual reality task-oriented physical activity lead to different changes in physical and task performance over time compared with usual work, rehabilitation, and daily activities?
- Does participation in virtual reality task-oriented physical activity lead to different changes in brain activity over time compared with usual work, rehabilitation, and daily activities?
Read more
Researchers compared participants who received the additional task-oriented physical activity training program with participants who continued their usual work, rehabilitation, and daily activities without additional training.
Participants in the intervention group:
- Participated in task-oriented physical activities using interactive video game-based activities and video-guided exercise.
- Completed training sessions three times per week.
- Completed assessments of physical and task performance and brain activity before and after the intervention and during follow-up.
Participants in the control group continued their usual work, rehabilitation, and daily activities and completed the same assessments over time.
- Conditions
- Intellectual Disability, Serious Mental Illness
- Being tested
- Virtual Reality Task-Oriented Physical Activity Training
- Keywords
- Mental Disabilities, Task-Oriented Training, Physical Activity, Active Video Games, Virtual Reality, Electroencephalography, Brain Network
- Medical subject headings
- Intellectual Disability, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Task-Oriented Physical Activity TrainingBehavioural
Participants received a 12-week task-oriented physical activity training program, with three 60-minute sessions per week. The program included interactive whole-body video game activities using the Nintendo Switch and standing video-guided aerobic exercises. Training involved goal-directed whole-body movements and was adjusted according to participants' abilities and performance. A therapist provided instructions, supervision, and assistance as needed during the training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this arm received the additional task-oriented physical activity training program in addition to their usual work, rehabilitation, and daily activities. Receives: Behavioral: Virtual Reality Task-Oriented Physical Activity Training |
| Control Group | No intervention | Participants in this arm continued their usual work, rehabilitation, and daily activities without receiving the additional task-oriented physical activity training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test
Gross manual dexterity was assessed using the Box and Block Test (BBT). The outcome was the number of blocks transferred from one compartment of a box to the other within 60 seconds. Two trials were performed at each assessment, and the mean number of blocks transferred across the two trials was used for analysis. A higher score indicated better gross manual dexterity.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Functional Reach Test
Functional balance was assessed using the Functional Reach Test (FRT). The outcome was the maximum distance the participant could reach forward while maintaining a fixed base of support, measured in centimeters. A greater reach distance indicated better functional balance.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Timed Up and Go Test
Functional mobility was assessed using the Timed Up and Go Test (TUG). The outcome was the time required to stand up from a chair, walk 3 meters, turn, walk back to the chair, and sit down, measured in seconds. Shorter completion time indicated better functional mobility.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
General Self-Efficacy Scale
Self-efficacy was assessed using the 10-item General Self-Efficacy Scale (GSES). Each item was rated on a 4-point Likert scale, yielding a total score ranging from 10 to 40. Higher scores indicated greater perceived self-efficacy.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Grooved Pegboard Test
Fine manual dexterity and visuomotor performance were assessed using the Grooved Pegboard Test (GPT). The outcome was completion time, measured in seconds. Two trials were performed at each assessment, and the mean completion time of the two trials was used for analysis. Shorter completion time indicated better performance.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Color Trails Test 1
Visual attention, visual search, and sequential processing were assessed using the Color Trails Test 1 (CTT1). The outcome was the time required to complete the test, measured in seconds. Shorter completion time indicated better performance.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Color Trails Test 2
Cognitive flexibility, alternating sequencing, and visual attention were assessed using the Color Trails Test 2 (CTT2). The outcome was the time required to complete the test, measured in seconds. Shorter completion time indicated better performance.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Electroencephalographic Activity During Task Performance
Brain activity was assessed using electroencephalography (EEG) during task performance. EEG signals were recorded to evaluate longitudinal changes in brain activity associated with the intervention, with particular interest in activity over frontal, sensorimotor, and parietal regions. Frequency-specific EEG activity was examined to characterize changes in neural activity over time.
Measured: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start27 Feb 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844525
- Sponsor's protocol ID
- 202301HM001
- Other IDs
- NSTC 112-2410-H-003-138-MY2
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because a formal data-sharing plan was not established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Virtual Reality Task-Oriented Physical Activities on Physical Function and Brain Reorganization in Adults With Mental Disabilities
- ClinicalTrials.gov ID
- NCT07844525
- Acronym / sponsor ID
- 202301HM001
- Conditions
- Intellectual Disability, Serious Mental Illness
- Keywords
- Mental Disabilities, Task-Oriented Training, Physical Activity, Active Video Games, Virtual Reality, Electroencephalography, Brain Network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study was to examine the effects of virtual reality task-oriented physical activity on physical and task performance and brain activity in adults with mental disabilities. The main questions it aimed to answer were:
- Does participation in virtual reality task-oriented physical activity lead to different changes in physical and task performance over time compared with usual work, rehabilitation, and daily activities?
- Does participation in virtual reality task-oriented physical activity lead to different changes in brain activity over time compared with usual work, rehabilitation, and daily activities?
Researchers compared participants who received the additional task-oriented physical activity training program with participants who continued their usual work, rehabilitation, and daily activities without additional training.
Participants in the intervention group:
- Participated in task-oriented physical activities using interactive video game-based activities and video-guided exercise.
- Completed training sessions three times per week.
- Completed assessments of physical and task performance and brain activity before and after the intervention and during follow-up.
Participants in the control group continued their usual work, rehabilitation, and daily activities and completed the same assessments over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Virtual Reality Task-Oriented Physical Activity TrainingParticipants in this arm received the additional task-oriented physical activity training program in addition to their usual work, rehabilitation, and daily activities. |
| Control Group | No intervention | –Participants in this arm continued their usual work, rehabilitation, and daily activities without receiving the additional task-oriented physical activity training program. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 20 years or older.
- Had a Category I disability certification and a medical diagnosis of intellectual disability or persistent severe mental illness.
- Diagnosis of intellectual disability or persistent severe mental illness for more than 1 year.
- Mini-Mental State Examination (MMSE) score greater than 18.
- Able to understand and follow verbal instructions and cooperate with the training and assessment procedures.
Key exclusion criteria (5 listed)
- Stroke or brain injury within the previous 6 months.
- Severe systemic disease, such as severe diabetes or heart disease, that substantially affected daily functioning.
- Mini-Mental State Examination (MMSE) score of 18 or lower.
- Unable to follow verbal instructions.
- Unable to cooperate with the training or assessment procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Task-Oriented Physical Activity TrainingParticipants received a 12-week task-oriented physical activity training program, with three 60-minute sessions per week. The program included interactive whole-body video game activities using the Nintendo Switch and standing video-guided aerobic exercises. Training involved goal-directed whole-body movements and was adjusted according to participants' abilities and performance. A therapist provided instructions, supervision, and assistance as needed during the training sessions. | Behavioural | Experimental Group |
Primary outcome
Box and Block Test
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Gross manual dexterity was assessed using the Box and Block Test (BBT). The outcome was the number of blocks transferred from one compartment of a box to the other within 60 seconds. Two trials were performed at each assessment, and the mean number of blocks transferred across the two trials was used for analysis. A higher score indicated better gross manual dexterity.
Functional Reach Test
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Functional balance was assessed using the Functional Reach Test (FRT). The outcome was the maximum distance the participant could reach forward while maintaining a fixed base of support, measured in centimeters. A greater reach distance indicated better functional balance.
Timed Up and Go Test
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Functional mobility was assessed using the Timed Up and Go Test (TUG). The outcome was the time required to stand up from a chair, walk 3 meters, turn, walk back to the chair, and sit down, measured in seconds. Shorter completion time indicated better functional mobility.
General Self-Efficacy Scale
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Self-efficacy was assessed using the 10-item General Self-Efficacy Scale (GSES). Each item was rated on a 4-point Likert scale, yielding a total score ranging from 10 to 40. Higher scores indicated greater perceived self-efficacy.
Grooved Pegboard Test
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Fine manual dexterity and visuomotor performance were assessed using the Grooved Pegboard Test (GPT). The outcome was completion time, measured in seconds. Two trials were performed at each assessment, and the mean completion time of the two trials was used for analysis. Shorter completion time indicated better performance.
Color Trails Test 1
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Visual attention, visual search, and sequential processing were assessed using the Color Trails Test 1 (CTT1). The outcome was the time required to complete the test, measured in seconds. Shorter completion time indicated better performance.
Color Trails Test 2
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Cognitive flexibility, alternating sequencing, and visual attention were assessed using the Color Trails Test 2 (CTT2). The outcome was the time required to complete the test, measured in seconds. Shorter completion time indicated better performance.
Electroencephalographic Activity During Task Performance
Time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.
Brain activity was assessed using electroencephalography (EEG) during task performance. EEG signals were recorded to evaluate longitudinal changes in brain activity associated with the intervention, with particular interest in activity over frontal, sensorimotor, and parietal regions. Frequency-specific EEG activity was examined to characterize changes in neural activity over time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because a formal data-sharing plan was not established for this study.
Related trials for Intellectual Disability
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingObservational study
Genome Medical Sequencing for Gene Discovery
Intellectual Disabilities, Congenital Anomaly
RecruitingObservational study
Neurophysiologic Biomarkers in Rett Syndrome
Rett Syndrome, RTT
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Task-Oriented Physical Activity Training in people with Intellectual Disability and Serious Mental Illness, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Block Test (time frame: Baseline (within 1 week before intervention), post-intervention (within 1 week after completion of the 12-week intervention), and follow-up at 12 and 36 weeks after completion of the intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.