Older PeopleCLNCT07814053
Dose-Response and Phase-Specific Effects of Graded Cognitive Load on Functional Mobility in Older Adults: A Kinematic Analysis
A study testing Dual-Task Cognitive Loading Protocol in people with Older People, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older People
- What is being tested?
- Dual-Task Cognitive Loading Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Banha University
Banhā, Qalyubia Governorate
Mostafa Seliem, teaching assistant, 02+01554049062, mostafasleim92@gmail.com
About this study
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.
- Conditions
- Older People
- Being tested
- Dual-Task Cognitive Loading Protocol
- Keywords
- Dose-Response and Phase-Specific, Graded Cognitive Load, Functional Mobility, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task Cognitive Loading ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Task Cognitive Loading Protocol | Experimental | 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. Receives: Other: Dual-Task Cognitive Loading Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to one day
Secondary outcomes (12)
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
Measured: up to one day
walking phase time
The smartwatch will be used to assess the time of the walking phase as a part of TUG test
Measured: up to one day
turning phase time
The smartwatch will be used to assess the time of the turning phase as a part of TUG test
Measured: up to one day
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
Measured: up to one day
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)
Measured: up to one day
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
Measured: up to one day
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
Measured: up to one day
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
Measured: up to one day
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
Measured: up to one day
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
Measured: up to one day
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.
Measured: up to one day
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.
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start20 Sep 2026
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose-Response and Phase-Specific Effects of Graded Cognitive Load
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abd-Elsamie Mohamed Abd-Elhamied seliem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814053
- Sponsor's protocol ID
- P.T.REC/012/006633
- Acronym
- CL
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response and Phase-Specific Effects of Graded Cognitive Load on Functional Mobility in Older Adults: A Kinematic Analysis
- ClinicalTrials.gov ID
- NCT07814053
- Acronym / sponsor ID
- CL / P.T.REC/012/006633
- Conditions
- Older People
- Keywords
- Dose-Response and Phase-Specific, Graded Cognitive Load, Functional Mobility, Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 10 Sep 2026 (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 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose-Response and Phase-Specific Effects of Graded Cognitive Load
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Cognitive Loading Protocol | Experimental | Other: Dual-Task Cognitive Loading Protocolsixty 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Dual-Task Cognitive Loading ProtocolParticipants 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. | Other | Dual-Task Cognitive Loading Protocol |
Primary outcome
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
12 secondary outcomes
sit-to-stand phase time
Time frame: up to one day
walking phase time
Time frame: up to one day
turning phase time
Time frame: up to one day
stand-to-sit phase
Time frame: up to one day
gait speed
Time frame: up to one day
step length
Time frame: up to one day
cadence
Time frame: up to one day
step time
Time frame: up to one day
turning duration
Time frame: up to one day
peak trunk flexion angle
Time frame: up to one day
peak hip flexion angle
Time frame: up to one day
peak knee flexion angle
Time frame: up to one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task Cognitive Loading Protocol in people with Older People, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mostafa seliem, master (01554049062, mostafasleim92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) Completion Time (time frame: up to one 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 27 Oct 2026.