NCT07103837

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 29, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Cognitive-motor testingReaction timeReactive skill

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 first day of inclusion in the study, once

  • Five Times Sit-to-Stand Test (FTSST)

    the first day of inclusion in the study, once

  • International Physical Activity Questionnaire (Short Form)

    the first day of inclusion in the study, once

  • Hand Reaction Time Test

    the first day of inclusion in the study, once

Study Arms (1)

Reactive Skill Test

EXPERIMENTAL
Other: Reactive Skill Test

Interventions

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.

Reactive Skill Test

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to ambulate independently
  • Scoring below 10 points on the Mini-Mental State Examination (MMSE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University

Balıkesir, Bigadiç, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pamukkale University

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

December 25, 2024

Primary Completion

March 20, 2025

Study Completion

June 12, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations