NCT07814053

Brief 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

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress9%
Sep 2026Feb 2027

First Submitted

Initial submission to the registry

September 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 5, 2026

Last Update Submit

September 5, 2026

Conditions

Keywords

Dose-Response and Phase-SpecificGraded Cognitive LoadFunctional MobilityOlder Adults

Outcome Measures

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

    up to one day

Secondary Outcomes (12)

  • sit-to-stand phase time

    up to one day

  • walking phase time

    up to one day

  • turning phase time

    up to one day

  • stand-to-sit phase

    up to one day

  • gait speed

    up to one day

  • +7 more secondary outcomes

Study Arms (1)

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.

Other: Dual-Task Cognitive Loading Protocol

Interventions

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.

Dual-Task Cognitive Loading Protocol

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

mostafa seliem, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Dose-Response and Phase-Specific Effects of Graded Cognitive Load
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator : mostafa abd-elsamei mohamed

Study Record Dates

First Submitted

September 5, 2026

First Posted

September 10, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09