Cognitive and Behavioral ImpairmentNCT06941506
Using SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia
A study testing VA-SPOZ exercise program in people with Cognitive and Behavioral Impairment and Sensory and Perceptual Impairment, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
This project was aimed to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment and sensory perceptual impairment of older adults with dementia in adult daycare centers. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Cognitive and Behavioral Impairment, Sensory and Perceptual Impairment
- What is being tested?
- VA-SPOZ exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Apr 2025to 18 Dec 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosed as dementia by a physician, or
- screened by the SPMSQ as dementia
- age 65 and older
Who cannot join
- have severe cardiopulmonary disease
- have physical mobility impairment
- have spinal cord injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Integration of SPOZ Technology to Support and Enhance the Vitality Acupunch Exercise Program for Improving the Cognitive Behavioral Impairment and Sensory Perceptual Impairment of Older Adults With Dementia
This project was aimed to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment and sensory perceptual impairment of older adults with dementia in adult daycare centers.
Read the detailed description
A cluster-randomized controlled trial was conducted to examine the effects of a six-month VA exercise program incorporated the SPOZ technology in improving the cognitive behavioral impairment (using Montreal Cognitive Assessment and Neuropsychiatric Inventory Questionnaire) and sensory perceptual impairment (using Pain Assessment in Advanced Dementia) of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 142 older adults were recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group received a 40-minute program 3 times a week for 6 months; the control group maintained their routine activities. The two groups were measured at three time points: before the intervention, and at three months and six months of the intervention.
- Being tested
- VA-SPOZ exercise program, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA-SPOZ exercise programOther
The VA-SPOZ exercise program had three phases and took 40 minutes to complete. The program was performed in a seated position, and the participants wore SPOZ devices on both hands to record and track the accuracy of the movements.
ControlOther
Participants maintained their routine activities.
| Study group | Role | What they receive |
|---|---|---|
| VA-SPOZ exercise program | Experimental | The VA-SPOZ exercise program was comprised of three parts: (1) the first part had 5 movements, including breathing regulation, alternating arm stretching, trunk movement, alternating left and right legs, and gradually started the blood circulation in a gentle way; (2) the second part had 14 movements, using five punching techniques, the left and right arms alternating in a natural parabola, and punching the acupoints to vibrate meridians. The purpose of the second part of the movement was to stimulate the 14 meridians and to promote the circulation of qi and blood throughout the body; (3) the third part had 5 movements, which were to adjust the breath, relax the muscles, stretch the body, and warm the face and lower back of the body by hand touch. Participants wore SPOZ devices on both hands to record and track the accuracy of the movements.The 40-minute program was administered three times a week for 6 months. Receives: Other: VA-SPOZ exercise program |
| Control | Active comparator | Participants in the control group maintained their routine activities. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive status
measured by the Montreal Cognitive Assessment. A scale that includes seven aspects: visuospatial and executive functioning, animal naming, delayed recall (short-term memory), attention, language, abstraction, and orientation. The total score ranges between 0 and 30: a score ≥ 26 indicates no cognitive impairment, 18-25 indicates mild cognitive impairment, 10-17 represents moderate impairment, and < 10 indicates severe impairment.
Measured: 6 months
Secondary outcomes (2)
Behavioral and psychological symptoms of dementia (BPSD)
measured by the Neuropsychiatric Inventory Questionnaire. The 12 items measure 12 psychiatric behavioral symptoms: delusions, hallucinations, agitation/aggression, depression/bad mood, anxiety, euphoria/elation, apathy, vocally disruptive behaviors, irritable/changeable mood, aberrant motor behaviors, sleep/nighttime behaviors, and changes in appetite/eating behaviors. The assessment consists of three parts: (1) to determine the presence or absence of symptoms, 0 = no, 1 = yes; (2) to determine the severity of the symptoms, rating between 1 and 3, and the total score is 36 with higher scores indicate more severe symptoms; (3) to rate the degree of caregiver's distress caused by the client's symptoms on a scale of 0-5, and the total score is 60 with higher scores indicating greater distress.
Measured: 6 months
Pain status
measured by the Pain Assessment in Advanced Dementia. A 5-item scale that includes patient's breathing pattern, uncomfortable/negative vocalization, facial expression, body language, and soothability. Scores are rated on a scale of 0-2. The total score is between 0 and 10; a higher score indicates a higher level of observed discomfort.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start23 Apr 2025
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive and Behavioral ImpairmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
- Investigators
- Kuei-Min Chen, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941506
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240009(1)
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2025
- Last updated
- 24 Dec 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Integration of SPOZ Technology to Support and Enhance the Vitality Acupunch Exercise Program for Improving the Cognitive Behavioral Impairment and Sensory Perceptual Impairment of Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT06941506
- Acronym / sponsor ID
- KMUHIRB-F(I)-20240009(1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 23 Apr 2025 (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.
This project was aimed to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment and sensory perceptual impairment of older adults with dementia in adult daycare centers.
Detailed description
A cluster-randomized controlled trial was conducted to examine the effects of a six-month VA exercise program incorporated the SPOZ technology in improving the cognitive behavioral impairment (using Montreal Cognitive Assessment and Neuropsychiatric Inventory Questionnaire) and sensory perceptual impairment (using Pain Assessment in Advanced Dementia) of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 142 older adults were recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group received a 40-minute program 3 times a week for 6 months; the control group maintained their routine activities. The two groups were measured at three time points: before the intervention, and at three months and six months of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA-SPOZ exercise program | Experimental | Other: VA-SPOZ exercise programThe VA-SPOZ exercise program was comprised of three parts: (1) the first part had 5 movements, including breathing regulation, alternating arm stretching, trunk movement, alternating left and right legs, and gradually started the blood circulation in a gentle way; (2) the second part had 14 movements, using five punching techniques, the left and right arms alternating in a natural parabola, and punching the acupoints to vibrate meridians. The purpose of the second part of the movement was to stimulate the 14 meridians and to promote the circulation of qi and blood throughout the body; (3) the third part had 5 movements, which were to adjust the breath, relax the muscles, stretch the body, and warm the face and lower back of the body by hand touch. Participants wore SPOZ devices on both hands to record and track the accuracy of the movements.The 40-minute program was administered three times a week for 6 months. |
| Control | Active comparator | Other: ControlParticipants in the control group maintained their routine activities. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- diagnosed as dementia by a physician, or
- screened by the SPMSQ as dementia
- age 65 and older
Key exclusion criteria (3 listed)
- have severe cardiopulmonary disease
- have physical mobility impairment
- have spinal cord injury
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 |
|---|---|---|
| VA-SPOZ exercise programThe VA-SPOZ exercise program had three phases and took 40 minutes to complete. The program was performed in a seated position, and the participants wore SPOZ devices on both hands to record and track the accuracy of the movements. | Other | VA-SPOZ exercise program |
| ControlParticipants maintained their routine activities. | Other | Control |
Primary outcome
Cognitive status
Time frame: 6 months
measured by the Montreal Cognitive Assessment. A scale that includes seven aspects: visuospatial and executive functioning, animal naming, delayed recall (short-term memory), attention, language, abstraction, and orientation. The total score ranges between 0 and 30: a score ≥ 26 indicates no cognitive impairment, 18-25 indicates mild cognitive impairment, 10-17 represents moderate impairment, and < 10 indicates severe impairment.
2 secondary outcomes
Behavioral and psychological symptoms of dementia (BPSD)
Time frame: 6 months
Pain status
Time frame: 6 months
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 24 Dec 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. This study is not recruiting at the moment.
Kuei-Min Chen, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA-SPOZ exercise program in people with Cognitive and Behavioral Impairment and Sensory and Perceptual Impairment, run by Kaohsiung Medical 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 3 inclusion and 3 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 24 Dec 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?
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?
Cognitive status (time frame: 6 months). 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 24 Dec 2025.