AgingNCT07103837
Development, Validity, and Reliability of the Reactive Skill Test in Older Adults
A study testing Reactive Skill Test in people with Aging and Cognitive Performance, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
Aging is associated with cognitive and physical decline, leading to an increased risk of falls in older adults. Recent evidence highlights the critical role of cognitive functions-such as attention, memory, and executive functioning-in postural control and fall risk. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Performance
- What is being tested?
- Reactive Skill Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2024to 12 Jun 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 60 years of age
- Scoring at least 10 points on the Mini-Mental State Examination (MMSE)
- Ability to ambulate independently
- Being literate
- Providing informed consent to participate in the study
Who cannot join
- Inability to ambulate independently
- Scoring below 10 points on the Mini-Mental State Examination (MMSE)
Trial locations and contacts
1 site in 1 country.
About this study
Aging is associated with cognitive and physical decline, leading to an increased risk of falls in older adults. Recent evidence highlights the critical role of cognitive functions-such as attention, memory, and executive functioning-in postural control and fall risk. This study aims to develop and validate a novel Reactive Skill Test (RST) that simultaneously assesses cognitive (reaction time, visual attention, short-term memory) and motor responses in older adults. The test involves matching colored stimuli to targets using a color-coded pod and cone setup controlled via the ReactionX system. The validity of RST will be examined through correlations with established cognitive and fall risk measures, while test-retest reliability will be assessed across separate sessions. This tool may provide early detection of cognitive-motor impairments contributing to fall risk in aging populations.
- Conditions
- Aging, Cognitive Performance
- Being tested
- Reactive Skill Test
- Keywords
- Cognitive-motor testing, Reaction time, Reactive skill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive Skill TestOther
The Reactive Skill Test will be conducted using a setup consisting of four pods, white cones, and balls that match the colors of the light signals During the test, a ReactionX device configured with four distinct light colors (red, green, blue, and yellow) will be used. The test protocol is programmed via the ReactionX mobile application to control the sequence and display of lights. Each LED light is illuminated in a randomized order with zero delay time. Upon illumination, the participant is required to select the ball corresponding to the color of the light, place it on the matching cone, and then deactivate the LED light of the same color as the last placed ball. The test concludes once this sequence is completed for all four lights. Performance is evaluated based on parameters such as reaction time, accuracy, and total completion time. This protocol is specifically designed to assess cognitive skills such as color recognition, reaction time, motor coordination, and attention.
| Study group | Role | What they receive |
|---|---|---|
| Reactive Skill Test | Experimental | Not described Receives: Other: Reactive Skill Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of the Reactive Skills Test
The Reactive Skill Test will be conducted using a setup consisting of four pods, white cones, and balls that match the colors of the light signals. During the test, a ReactionX device configured with four distinct light colors (red, green, blue, and yellow) will be used. The test protocol is programmed via the ReactionX mobile application to control the sequence and display of lights. Each LED light is illuminated in a randomized order with zero delay time. Upon illumination, the participant is required to select the ball corresponding to the color of the light, place it on the matching cone, and then deactivate the LED light of the same color as the last placed ball. The test concludes once this sequence is completed for all four lights. Performance is evaluated based on parameters such as reaction time, accuracy, and total completion time. This protocol is specifically designed to assess cognitive skills such as color recognition, reaction speed, motor coordination and attention.
Measured: For the reliability of RBT, the test will be performed again one week later at the same time of day.
Secondary outcomes (4)
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is widely recognized as one of the most commonly used tools for assessing cognitive impairment worldwide. The MMSE evaluates orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities. Its ease and rapid administration are among its main advantages. In this study, the MMSE will be used to assess cognitive function. Scores ranging from 27 to 30 are considered normal, 24 to 27 indicate mild cognitive impairment, 20 to 23 represent mild dementia, 10 to 19 correspond to moderate dementia, and scores below 10 indicate severe dementia.
Measured: the first day of inclusion in the study, once
Five Times Sit-to-Stand Test (FTSST)
The Five Times Sit-to-Stand Test is a standardized assessment used to evaluate lower extremity muscle strength and balance in older adults. Participants sit on a backless chair 45 cm in height with their arms crossed over their chest and are instructed to stand up and sit down five times as quickly as possible. Performance is measured by timing the duration from the initial seated position to the final seated position using a stopwatch. The validity of the test is supported by its correlation with measures of knee extension strength and walking performance. It assesses lower limb strength and functional mobility. Times exceeding 15 seconds are associated with a higher risk of falls. The test will be performed three times, and the average time will be recorded.
Measured: the first day of inclusion in the study, once
International Physical Activity Questionnaire (Short Form)
This questionnaire will be used to assess participants' physical activity levels in daily life. Participants report the types of activities performed and the time spent on each over the past seven days. Walking, sitting, moderate-intensity, and vigorous-intensity activities will be recorded based on participant self-report. The score is calculated by multiplying the MET value assigned to each activity by the duration and the number of days performed per week, resulting in a MET-minutes/week value. MET values are assigned as follows: walking = 3.3 MET, moderate activity = 4 MET, and vigorous activity = 8 MET. Based on these scores, participants will be classified into three categories: physically inactive (<600 MET-min/week), low physical activity level (600-1500 MET-min/week), and sufficient physical activity level (>1500 MET-min/week).
Measured: the first day of inclusion in the study, once
Hand Reaction Time Test
Hand movement reaction times will be recorded using an LED light system connected to a smartphone application (ReactionX). The ReactionX system consists of six LEDs and a wireless lighting setup. Participants will be seated with both hands placed on the table, palms down, spaced 40 cm apart (ReactionX device positioned centrally, 20 cm from each hand) and elbows flexed at 90°. When a light illuminates, participants are instructed to touch the device with the indicated hand as quickly as possible to turn off the light. Each test will be performed six times, with the best trial recorded. Results will be expressed in milliseconds (ms).
Measured: the first day of inclusion in the study, once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start25 Dec 2024
- Primary completion20 Mar 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Tekin, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103837
- Sponsor's protocol ID
- 2024/22
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validity, and Reliability of the Reactive Skill Test in Older Adults
- ClinicalTrials.gov ID
- NCT07103837
- Acronym / sponsor ID
- 2024/22
- Conditions
- Aging, Cognitive Performance
- Keywords
- Cognitive-motor testing, Reaction time, Reactive skill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 5 Aug 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.
Aging is associated with cognitive and physical decline, leading to an increased risk of falls in older adults. Recent evidence highlights the critical role of cognitive functions-such as attention, memory, and executive functioning-in postural control and fall risk. This study aims to develop and validate a novel Reactive Skill Test (RST) that simultaneously assesses cognitive (reaction time, visual attention, short-term memory) and motor responses in older adults. The test involves matching colored stimuli to targets using a color-coded pod and cone setup controlled via the ReactionX system. The validity of RST will be examined through correlations with established cognitive and fall risk measures, while test-retest reliability will be assessed across separate sessions. This tool may provide early detection of cognitive-motor impairments contributing to fall risk in aging populations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reactive Skill Test | Experimental | Other: Reactive Skill Test |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being over 60 years of age
- Scoring at least 10 points on the Mini-Mental State Examination (MMSE)
- Ability to ambulate independently
- Being literate
- Providing informed consent to participate in the study
Key exclusion criteria (2 listed)
- Inability to ambulate independently
- Scoring below 10 points on the Mini-Mental State Examination (MMSE)
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 |
|---|---|---|
| Reactive Skill TestThe Reactive Skill Test will be conducted using a setup consisting of four pods, white cones, and balls that match the colors of the light signals During the test, a ReactionX device configured with four distinct light colors (red, green, blue, and yellow) will be used. The test protocol is programmed via the ReactionX mobile application to control the sequence and display of lights. Each LED light is illuminated in a randomized order with zero delay time. Upon illumination, the participant is required to select the ball corresponding to the color of the light, place it on the matching cone, and then deactivate the LED light of the same color as the last placed ball. The test concludes once this sequence is completed for all four lights. Performance is evaluated based on parameters such as reaction time, accuracy, and total completion time. This protocol is specifically designed to assess cognitive skills such as color recognition, reaction time, motor coordination, and attention. | Other | Reactive Skill Test |
Primary outcome
Development of the Reactive Skills Test
Time frame: For the reliability of RBT, the test will be performed again one week later at the same time of day.
The Reactive Skill Test will be conducted using a setup consisting of four pods, white cones, and balls that match the colors of the light signals. During the test, a ReactionX device configured with four distinct light colors (red, green, blue, and yellow) will be used. The test protocol is programmed via the ReactionX mobile application to control the sequence and display of lights. Each LED light is illuminated in a randomized order with zero delay time. Upon illumination, the participant is required to select the ball corresponding to the color of the light, place it on the matching cone, and then deactivate the LED light of the same color as the last placed ball. The test concludes once this sequence is completed for all four lights. Performance is evaluated based on parameters such as reaction time, accuracy, and total completion time. This protocol is specifically designed to assess cognitive skills such as color recognition, reaction speed, motor coordination and attention.
4 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: the first day of inclusion in the study, once
Five Times Sit-to-Stand Test (FTSST)
Time frame: the first day of inclusion in the study, once
International Physical Activity Questionnaire (Short Form)
Time frame: the first day of inclusion in the study, once
Hand Reaction Time Test
Time frame: the first day of inclusion in the study, once
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 5 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. 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 Reactive Skill Test in people with Aging and Cognitive Performance, run by Balikesir University at 1 site in Turkey (Türkiye).
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 2 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 5 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 Turkey (Türkiye). 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?
Development of the Reactive Skills Test (time frame: For the reliability of RBT, the test will be performed again one week later at the same time of day.). 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 5 Aug 2025.