ClinicalTrials.gg
RecruitingNCT07814053CLUpdated Oct 27, 2026

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

An interventional study of Dual-Task Cognitive Loading Protocol in Older People, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 27, 2026Now RecruitingFirst site in Egypt+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Older People

Keywords

  • Dose-Response and Phase-Specific
  • Graded Cognitive Load
  • Functional Mobility
  • Older Adults
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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
  • (BMI) between 18.5 and 29.9 kg/m², as values ≥ 30 kg/m² (obesity) may adversely affect gait and balance performance.

Exclusion criteria

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 (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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Dual-Task Cognitive Loading Protocol

    sixty Participants will perform the time-up-and-go test under four standardized experimental conditions designed to investigate the dose-response and phase-specific effects of graded cognitive load on functional mobility in older adults.

    Other: Dual-Task Cognitive Loading Protocol

Interventions

  • OtherDual-Task Cognitive Loading Protocol

    Participants will perform the TUG test under four standardized experimental conditions: 1\. 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.

06

What researchers measure

Primary outcomes

  1. Timed Up and Go (TUG) Completion Time

    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

    Time frame: up to one day

Secondary outcomes

  1. sit-to-stand phase time

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

    Time frame: up to one day

  2. walking phase time

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

    Time frame: up to one day

  3. turning phase time

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

    Time frame: up to one day

  4. stand-to-sit phase

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

    Time frame: up to one day

  5. gait speed

    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)

    Time frame: up to one day

  6. step length

    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

    Time frame: up to one day

  7. cadence

    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

    Time frame: up to one day

  8. step time

    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

    Time frame: up to one day

  9. turning duration

    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

    Time frame: up to one day

  10. peak trunk flexion angle

    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

    Time frame: up to one day

  11. peak hip flexion angle

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

    Time frame: up to one day

  12. peak knee flexion angle

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

    Time frame: up to one day

07

Study locations

1 of 1 sites recruiting
  • Faculty of Physical Therapy Banha University
    Banhā, Qalyubia Governorate, Egypt
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2026
First posted
Sep 10, 2026
StartActual
Sep 20, 2026
Primary completionEst.
Feb 20, 2027
CompletionEst.
Feb 20, 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 27, 2026
Sites
1 site added — first site in Egypt
Show site
  • Faculty of Physical Therapy Banha University · Banhā, Egypt
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Egypt
    Show site
    • Faculty of Physical Therapy Banha University · Banhā, Egypt
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07814053
Lead sponsor
Cairo University
Responsible party
Mostafa Abd-Elsamie Mohamed Abd-Elhamied seliem (principle investigator : mostafa abd-elsamei mohamed, Cairo University) — Principal investigator
First posted
Sep 10, 2026
Start date
Sep 20, 2026
Primary completion
Feb 20, 2027 (estimated)
Completion
Feb 20, 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

mostafa seliem, master
Contact
mostafasleim92@gmail.com
01554049062

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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