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NCT Number: NCT07814053

Dose-Response and Phase-Specific Effects of Graded Cognitive Load on Functional Mobility in Older Adults: A Kinematic Analysis

This study will be conducted to investigate the effect of dose-response and phase-specific effects of Graded Cognitive Load affect on functional mobility in Older Adults

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Aging is associated with progressive changes in both the central nervous system and the musculoskeletal system, leading to declines in motor performance, balance, and functional mobility. These changes include reduced cortical processing efficiency, slower information processing speed, and alterations in sensorimotor integration, all of which contribute to decreased movement efficiency in older adults. Functional mobility, particularly walking and transitional movements, is no longer considered a purely automatic motor task, but rather a cognitively mediated activity that requires continuous interaction between attentional resources and motor control systems. Clinically, previous studies have demonstrated that dual-task performance is strongly associated with fall risk and mobility impairment in older adults, suggesting 6 its importance in functional assessment and rehabilitation planning.Despite these advances, most of the existing research has primarily focused on binary dual-task paradigms, comparing single-task versus dual-task conditions without considering different levels of cognitive demand. This approach limits the ability to understand whether cognitive-motor interference follows a dose-response relationship, where progressively increasing cognitive load produces graded deterioration in motor performance. Furthermore, while overall gait and mobility outcomes have been widely investigated, there is a lack of detailed evidence regarding how cognitive load influences specific phases of functional mobility tasks, such as sit-to-stand, gait, turning, and stand-to-sit transitions. Previous studies suggest that different movement phases may vary in their sensitivity to cognitive interference due to differences in biomechanical and postural control demands. However, this phasespecific behavior remains underexplored, particularly in the context of graded cognitive loading.

Therefore, there is a clear gap in the literature regarding the combined effect of graded cognitive load and phase-specific motor behavior during functional mobility tasks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 60 years
  • Ability to ambulate independently without assistive devices
  • Ability to follow verbal instructions and perform dual-task activities
  • Medically stable and capable of participating in functional mobility assessment Cognitive function within normal range, defined as Mini-Mental State Examination (MMSE) score ≥ 24 out of 30, indicating absence of significant cognitive impairment .
  • Functionqal independence in basic activities of daily living, defined as Barthel Index score ≥ 90 out of 100
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m², as values ≥ 30 kg/m² (obesity) may adversely affect gait and balance performance.

Exclusion criteria

  • Any neurological disease that affects walking or balance, such as stroke or Parkinson's disease
  • Any musculoskeletal condition that limits lower-limb movement or affects normal walking patterns
  • Severe cognitive impairment defined as Mini-Mental State Examination (MMSE) score < 24
  • Visual, vestibular, or hearing problems that affect safe walking or balance control
  • History of lower-limb injury or surgery within the last 6 months
  • Serious medical conditions that make participation unsafe, such as unstable cardiac or respiratory disease

Treatment and study plan

Dual-Task Cognitive Loading Protocol

Other

Participants will perform the TUG test under four standardized experimental conditions:

  • Single-Task Condition (Baseline) : Participants will perform TUG test without any additional cognitive task.

2-Low Cognitive Load Condition:Participants will perform the TUG test while simultaneously performing simple backward counting by ones starting from a randomly assigned number between 90 and 100.

3-Moderate Cognitive Load Condition :Participants will perform the TUG test while simultaneously performing serial backward counting by threes starting from a randomly assigned number between 90 and 100.

4-High Cognitive Load Condition:Participants will perform the TUG test while simultaneously performing serial subtraction by sevens (Serial 7s task) starting from a randomly assigned number between 90 and 100.

Primary outcomes

  1. Timed Up and Go (TUG) Completion Time

    Time frame: up to one day

    A smartwatch will be used to assess the completion time of the TUG test. The total time required to complete the TUG test under each cognitive load condition will be recorded in seconds and used as the primary measure of functional mobility performance. Increased TUG completion time will indicate deterioration in functional mobility under cognitive interference conditions

Secondary outcomes

  1. sit-to-stand phase time

    Time frame: up to one day

    A smartwatch will be used to assess the time of sit-to-stand phase as a part of the TUG test

  2. walking phase time

    Time frame: up to one day

    The smartwatch will be used to assess the time of the walking phase as a part of TUG test

  3. turning phase time

    Time frame: up to one day

    The smartwatch will be used to assess the time of the turning phase as a part of TUG test

  4. stand-to-sit phase

    Time frame: up to one day

    The smartwatch will be used to assess the time of the stand-to-sit phase as a part of TUG tes

  5. gait speed

    Time frame: up to one day

    A sagittal-plane video-based kinematic analysis system will be used to evaluate gait speed.ormal gait speed for healthy adults generally ranges from 1.2 to 1.4 meters per second (m/s)

  6. step length

    Time frame: up to one day

    A sagittal-plane video-based kinematic analysis system will be used to evaluate step length. The normal walking step length is about 2.5 feet (75 to 79 cm) for men and 2.2 feet (66 to 69 cm) for women

  7. cadence

    Time frame: up to one day

    A sagittal-plane video-based kinematic analysis system will be used to evaluate cadence. A normal comfortable walking cadence for healthy adults generally ranges from 100 to 120 steps per minute

  8. step time

    Time frame: up to one day

    A sagittal-plane video-based kinematic analysis system will be used to evaluate step time. the normal step time for a healthy adult walking at a comfortable, self-selected speed is approximately 0.5 seconds per single step

  9. turning duration

    Time frame: up to one day

    A sagittal-plane video-based kinematic analysis system will be used to evaluate turning duration.For healthy, normal adults, the average turning durations typically fall into these ranges from 1.4 to 1.5 seconds

  10. peak trunk flexion angle

    Time frame: up to one day

    sagittal-plane video-based kinematic analysis system will be used to evaluate peak trunk flexion.Studies show that actively flexing the trunk increases peak angles (reaching higher ranges like an added 47° in intentional flexed landings vs. preferred landings) which helps absorb impact and protect the knees

  11. peak hip flexion angle

    Time frame: up to one day

    the sagittal-plane video-based kinematic analysis system will be used to evaluate peak hip flexion angle. it should be from 130-140 degree.

  12. peak knee flexion angle

    Time frame: up to one day

    The sagittal-plane video-based kinematic analysis system will be used to evaluate peak knee flexion angle. it should be from 120-150 degree.

Study contacts

Contact information is provided by the study sponsor or research team.

mostafa seliem, master

CONTACT

[email protected]

01554049062

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: CL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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