Virtual RealityNCT06151626
A Novel Multisensory-Rhythmic Intervention in Geriatric Rehabilitation
A study testing virtual-reality based rhythmic skill training, rhythmic skill training with visual feedback and strengthening group in people with Virtual Reality and Hand Mirror, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Human performance takes shape from the dynamic interaction between person, environment, and task. Goal-directed action is a complex task, which requires the elderly to adapt their motor response according to the environment constraints and task requirements to accomplish the task goal. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Hand Mirror, Geriatric
- What is being tested?
- virtual-reality based rhythmic skill training, rhythmic skill training with visual feedback and strengthening group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Dec 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment (MoCA) score of 23 or higher,
- Clinical Dementia Rating (CDR) of 0 (for normal subjects) or 1 (for mild cognitive impairment subjects),
- Healthy young participants aged between 20-39 years, healthy older adults and mild cognitive impairment participants aged between 65-85 years,
- No skeletal, muscular, or neurological problems in the upper limbs in the past year, and
- Sufficient visual acuity to complete the tasks.
Who cannot join
- Any subjects with significant mental illness, central nervous system disorders, or medical history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Hsiu-Yun Hsu, PhD
About this study
Official title: Linking From an Artificial-Intelligence Driven Assessment of Upper Extremity Motor Adaptation to a Novel Multisensory-Rhythmic Intervention in Geriatric Rehabilitation
Human performance takes shape from the dynamic interaction between person, environment, and task. Goal-directed action is a complex task, which requires the elderly to adapt their motor response according to the environment constraints and task requirements to accomplish the task goal. Among age-related problems, motor control deficits are often the main problems which restricts the frail elderly from maintaining independence for activities of daily living. Therefore, to preserve the quality of life, motor function of the elderly must be taken into consideration, including early detection of motor control problems and development of appropriate intervention strategy for persons with either healthy or pathological brain aging. Rhythmic skill training which is a new mode of dual tasks using rhythmic cueing as an external agent for facilitating an automatized motor task. During training, rhythmic skill training can provide multi-component of sensory stimulation, strengthen motor planning and optimize motor execution, therefore, it will improve the motor performance for the elderly or patients with mild cognitive impairment. In addition, the neuroplastic changes related to sensory processing, selective attention, or working memory demands through music rhythm training can facilitate the cognitive function for the elderly which is a current trend of geriatric rehabilitation. Moreover, the advantage of virtual reality is that it provides important information related to knowledge of result, which can induce better motor and cognitive training effects. Therefore, this research project will focus on assessing and intervening motor adaptation of upper extremity for the healthy elderly and patients with mild cognitive impairment. The first purpose of the project will analyze the difference in efficiency of responsive and predictive grasping motor adaptation among the healthy young adults, healthy elderly and patients with mild cognitive impairment through a test of perturbation-based of pinch-holding-up-activity, and use artificial intelligence for more accurate classification for the grasp pattern of healthy young adults, elderly and patients with mild cognitive impairment. The second one is to verify the effects of virtual-reality based rhythmic skill training system on the motor adaptation capability of upper limb and cognition for the elderly and patients with mild cognitive impairment.
- Conditions
- Virtual Reality, Hand Mirror, Geriatric, Kinesiology, Applied
- Being tested
- virtual-reality based rhythmic skill training, rhythmic skill training with visual feedback, strengthening group, breathing and muscle relaxation exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual-reality based rhythmic skill trainingOther
Participants wear VR headsets and Oculus Touch controllers and undergo rhythm skill training for a total of 35 minutes.
rhythmic skill training with visual feedbackOther
The rhythm skill training activities in this group are the same as the virtual reality-based system. Participants received 35 minutes of rhythm skill training presented through a computer interface
strengthening groupOther
Participants receive an upper limb strengthening exercise program under the supervision of a therapist to ensure that the strengthening exercises are performed correctly. This includes: proprioceptive neuromuscular facilitation, resistance training, and tendon gliding exercises.
breathing and muscle relaxation exercisesOther
5 minutes of breathing and muscle relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| virtual-reality based rhythmic skill training | Experimental | Participants wear VR headsets and Oculus Touch controllers and undergo rhythm skill training for a total of 35 minutes. Receives: Other: virtual-reality based rhythmic skill training; Other: breathing and muscle relaxation exercises |
| rhythmic skill training with visual feedback | Active comparator | The rhythm skill training activities in this group are the same as the virtual reality-based system. Participants received 35 minutes of rhythm skill training presented through a computer interface Receives: Other: rhythmic skill training with visual feedback; Other: breathing and muscle relaxation exercises |
| strengthening group | Active comparator | The patients receive an upper limb strengthening exercise program under the supervision of a therapist to ensure that the strengthening exercises are performed correctly. This includes: proprioceptive neuromuscular facilitation, resistance training, and tendon gliding exercises. Receives: Other: strengthening group; Other: breathing and muscle relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in responsive grip behavior
To evaluate change in amplitude of pinch force development or adaptation to perturbation through a test of perturbation-based of pinch-holding-up-activity
Measured: baseline, 8 weeks and 16 weeks
Secondary outcomes (8)
Change in the results of Semmes-Weinstein monofilament test
To evaluate change in touch-deep pressure threshold of hands using a set of 20 nylon monofilaments with Semmes-Weinstein monofilament test
Measured: baseline, 8 weeks and 16 weeks
Change in the result of Purdue pegboard test
To evaluate change in hand dexterity of dominant hand, non-dominant and both hands with a timed-test
Measured: baseline, 8 weeks and 16 weeks
Change in the result of Minnesota manual dexterity test
To evaluate change in gross motor coordination of upper limb of dominant hand and both hands with a timed placing and turning test
Measured: baseline, 8 weeks and 16 weeks
Change in the result of Weber Two-Point Discrimination Test
To evaluate the change in sensibility of the hands
Measured: baseline, 8 weeks and 16 weeks
The change in the results of Mini-Mental Status Examination (MMSE)
To evaluate the changes in cognitive function in an individual over time with The MMSE test
Measured: baseline, 8 weeks and 16 weeks
The change in the results of Digit Span (DS) subtest from the Wechsler Adult Intelligence Scale-4th
To evaluate the change in working memory, mental manipulation, cognitive flexibility and attention in an individual over time with Digit Span (DS) subtest
Measured: baseline, 8 weeks and 16 weeks
The change in the results of Knox Cube Test-Revised (KCT-R)
To evaluate the change in short-term memory and attention span in an individual over time with a performance test
Measured: baseline, 8 weeks and 16 weeks
The change in the results of Conners continuous performance test-3
To evaluate attention related problems in an individual over time with a performance test
Measured: baseline, 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start5 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151626
- Sponsor's protocol ID
- B-ER-111-482
- Status last verified
- Aug 2025
- First submitted
- 20 Nov 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking From an Artificial-Intelligence Driven Assessment of Upper Extremity Motor Adaptation to a Novel Multisensory-Rhythmic Intervention in Geriatric Rehabilitation
- ClinicalTrials.gov ID
- NCT06151626
- Acronym / sponsor ID
- B-ER-111-482
- Conditions
- Virtual Reality, Hand Mirror, Geriatric, Kinesiology, Applied
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Nov 2023 (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.
Human performance takes shape from the dynamic interaction between person, environment, and task. Goal-directed action is a complex task, which requires the elderly to adapt their motor response according to the environment constraints and task requirements to accomplish the task goal. Among age-related problems, motor control deficits are often the main problems which restricts the frail elderly from maintaining independence for activities of daily living. Therefore, to preserve the quality of life, motor function of the elderly must be taken into consideration, including early detection of motor control problems and development of appropriate intervention strategy for persons with either healthy or pathological brain aging. Rhythmic skill training which is a new mode of dual tasks using rhythmic cueing as an external agent for facilitating an automatized motor task. During training, rhythmic skill training can provide multi-component of sensory stimulation, strengthen motor planning and optimize motor execution, therefore, it will improve the motor performance for the elderly or patients with mild cognitive impairment. In addition, the neuroplastic changes related to sensory processing, selective attention, or working memory demands through music rhythm training can facilitate the cognitive function for the elderly which is a current trend of geriatric rehabilitation. Moreover, the advantage of virtual reality is that it provides important information related to knowledge of result, which can induce better motor and cognitive training effects. Therefore, this research project will focus on assessing and intervening motor adaptation of upper extremity for the healthy elderly and patients with mild cognitive impairment. The first purpose of the project will analyze the difference in efficiency of responsive and predictive grasping motor adaptation among the healthy young adults, healthy elderly and patients with mild cognitive impairment through a test of perturbation-based of pinch-holding-up-activity, and use artificial intelligence for more accurate classification for the grasp pattern of healthy young adults, elderly and patients with mild cognitive impairment. The second one is to verify the effects of virtual-reality based rhythmic skill training system on the motor adaptation capability of upper limb and cognition for the elderly and patients with mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| virtual-reality based rhythmic skill training | Experimental | Other: virtual-reality based rhythmic skill training, Other: breathing and muscle relaxation exercisesParticipants wear VR headsets and Oculus Touch controllers and undergo rhythm skill training for a total of 35 minutes. |
| rhythmic skill training with visual feedback | Active comparator | Other: rhythmic skill training with visual feedback, Other: breathing and muscle relaxation exercisesThe rhythm skill training activities in this group are the same as the virtual reality-based system. Participants received 35 minutes of rhythm skill training presented through a computer interface |
| strengthening group | Active comparator | Other: strengthening group, Other: breathing and muscle relaxation exercisesThe patients receive an upper limb strengthening exercise program under the supervision of a therapist to ensure that the strengthening exercises are performed correctly. This includes: proprioceptive neuromuscular facilitation, resistance training, and tendon gliding exercises. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Montreal Cognitive Assessment (MoCA) score of 23 or higher,
- Clinical Dementia Rating (CDR) of 0 (for normal subjects) or 1 (for mild cognitive impairment subjects),
- Healthy young participants aged between 20-39 years, healthy older adults and mild cognitive impairment participants aged between 65-85 years,
- No skeletal, muscular, or neurological problems in the upper limbs in the past year, and
- Sufficient visual acuity to complete the tasks.
Key exclusion criteria (1 listed)
- Any subjects with significant mental illness, central nervous system disorders, or medical history
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 based rhythmic skill trainingParticipants wear VR headsets and Oculus Touch controllers and undergo rhythm skill training for a total of 35 minutes. | Other | virtual-reality based rhythmic skill training |
| rhythmic skill training with visual feedbackThe rhythm skill training activities in this group are the same as the virtual reality-based system. Participants received 35 minutes of rhythm skill training presented through a computer interface | Other | rhythmic skill training with visual feedback |
| strengthening groupParticipants receive an upper limb strengthening exercise program under the supervision of a therapist to ensure that the strengthening exercises are performed correctly. This includes: proprioceptive neuromuscular facilitation, resistance training, and tendon gliding exercises. | Other | strengthening group |
| breathing and muscle relaxation exercises5 minutes of breathing and muscle relaxation exercises | Other | rhythmic skill training with visual feedback, strengthening group, virtual-reality based rhythmic skill training |
Primary outcome
Change in responsive grip behavior
Time frame: baseline, 8 weeks and 16 weeks
To evaluate change in amplitude of pinch force development or adaptation to perturbation through a test of perturbation-based of pinch-holding-up-activity
8 secondary outcomes
Change in the results of Semmes-Weinstein monofilament test
Time frame: baseline, 8 weeks and 16 weeks
Change in the result of Purdue pegboard test
Time frame: baseline, 8 weeks and 16 weeks
Change in the result of Minnesota manual dexterity test
Time frame: baseline, 8 weeks and 16 weeks
Change in the result of Weber Two-Point Discrimination Test
Time frame: baseline, 8 weeks and 16 weeks
The change in the results of Mini-Mental Status Examination (MMSE)
Time frame: baseline, 8 weeks and 16 weeks
The change in the results of Digit Span (DS) subtest from the Wechsler Adult Intelligence Scale-4th
Time frame: baseline, 8 weeks and 16 weeks
The change in the results of Knox Cube Test-Revised (KCT-R)
Time frame: baseline, 8 weeks and 16 weeks
The change in the results of Conners continuous performance test-3
Time frame: baseline, 8 weeks and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 based rhythmic skill training, rhythmic skill training with visual feedback and strengthening group in people with Virtual Reality and Hand Mirror, run by National Cheng-Kung University Hospital 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiu-Yun Hsu, Ph.D (886-6-2353535 ext. 2669, hyhsu@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in responsive grip behavior (time frame: baseline, 8 weeks and 16 weeks). 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 21 Aug 2025.