NCT06656052

Brief Summary

The goal of this study is to determine how different types of cognitive loading affect the gait of an individual and its association with growing age. The main aim is to find out if:

  1. 1.There is a significant difference in the effect of three different methods of cognitive loading on gait parameters across age groups.
  2. 2.There is an association of cognitive loading with different age groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

October 8, 2024

Last Update Submit

January 10, 2025

Conditions

Keywords

gaitcognitive loadcognitive loading

Outcome Measures

Primary Outcomes (24)

  • Walking speed

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the walking speed of the participant. A decrease in walking speed is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Walking speed

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the walking speed of the participant. A decrease in walking speed is the usual effect of cognitive loading on this gait parameter.

    During three cognitive tasks

  • Walking speed

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the walking speed of the participant. A decrease in walking speed is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

  • Gait Symmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the gait symmetry of the participant. A decrease in gait symmetry is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Gait Symmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the gait symmetry of the participant. A decrease in gait symmetry is the usual effect of cognitive loading on this gait parameter.

    During Cognitive loading tests

  • Gait Symmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the gait symmetry of the participant. A decrease in gait symmetry is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

  • Step length

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length of the participant. An increase in step length is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Step length

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length of the participant. An increase in step length is the usual effect of cognitive loading on this gait parameter.

    During Cognitive loading tests

  • Step length

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length of the participant. An increase in step length is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

  • Step length variability

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length variability of the participant. An increase in step length variability is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Step length variability

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length variability of the participant. An increase in step length variability is the usual effect of cognitive loading on this gait parameter.

    During Cognitive loading tests

  • Step length variability

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length variability of the participant. An increase in step length variability is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

  • Step time

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time of the participant. An increase in step time is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Step time

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time of the participant. An increase in step time is the usual effect of cognitive loading on this gait parameter.

    During Cognitive loading tests

  • Step time

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time of the participant. An increase in step time is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

  • Step time variability

    Smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time variability of the participant. An increase in step time variability is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Step time variability

    Smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time variability of the participant. An increase in step time variability is the usual effect of cognitive loading on this gait parameter.

    During Cognitive loading tests

  • Step time variability

    Smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time variability of the participant. An increase in step time variability is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

  • Step length asymmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length asymmetry of the participant. An increase in step length asymmetry is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Step length asymmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length asymmetry of the participant. An increase in step length asymmetry is the usual effect of cognitive loading on this gait parameter.

    During Cognitive loading tests

  • Step length asymmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step length asymmetry of the participant. An increase in step length asymmetry is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

  • Step time asymmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time asymmetry of the participant. An increase in step time asymmetry is the usual effect of cognitive loading on this gait parameter.

    Baseline

  • Step time asymmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time asymmetry of the participant. An increase in step time asymmetry is the usual effect of cognitive loading on this gait parameter.

    During Cognitive loading tests

  • Step time asymmetry

    A smartphone-based accelerometer through a mobile app named Gait \& Balance (G\&B app) will be used to detect the step time asymmetry of the participant. An increase in step time asymmetry is the usual effect of cognitive loading on this gait parameter.

    Immediately after Cognitive loading tests

Study Arms (5)

First Age Group

EXPERIMENTAL

Participants with Age 21-30 years. All members of group number 1 who fall in the eligibility criteria will undergo three different types of cognitive loading. Three types of cognitive loading will be applied randomly to eliminate any bias. Each Method will be used three times with pre and post-recordings to ensure reliability.

Other: 1. working memory task.Other: 2. Visual and Verbal Fluency TaskOther: 3. Motor Task

Second Age Group

EXPERIMENTAL

Participants with age 31-40 years. All members of group number 2 who fall in the eligibility criteria will undergo three different types of cognitive loading. Three types of cognitive loading will be applied randomly to eliminate any bias. Each Method will be used three times with pre and post-recordings to ensure reliability.

Other: 1. working memory task.Other: 2. Visual and Verbal Fluency TaskOther: 3. Motor Task

Third Age Group

EXPERIMENTAL

Participants with Age 41-50 years. All members of group number 3 who fall in the eligibility criteria will undergo three different types of cognitive loading. Three types of cognitive loading will be applied randomly to eliminate any bias. Each Method will be used three times with pre and post-recordings to ensure reliability.

Other: 1. working memory task.Other: 2. Visual and Verbal Fluency TaskOther: 3. Motor Task

Fourth Age Group

EXPERIMENTAL

Participants with age 51-60 years. All members of group number 4 who fall in the eligibility criteria will undergo three different types of cognitive loading. Three types of cognitive loading will be applied randomly to eliminate any bias. Each Method will be used three times with pre and post-recordings to ensure reliability.

Other: 1. working memory task.Other: 2. Visual and Verbal Fluency TaskOther: 3. Motor Task

Fifth Age Group

EXPERIMENTAL

Participants with age 61-70 years. All members of group number 5 who fall in the eligibility criteria will undergo three different types of cognitive loading. Three types of cognitive loading will be applied randomly to eliminate any bias. Each Method will be used three times with pre and post-recordings to ensure reliability.

Other: 1. working memory task.Other: 2. Visual and Verbal Fluency TaskOther: 3. Motor Task

Interventions

Arithmetic test (Backward counting with serial 3 subtraction and articulation): participants will be asked to count out loud backward with serial subtraction of 3 from each number, starting with a random number provided by the researcher.

Fifth Age GroupFirst Age GroupFourth Age GroupSecond Age GroupThird Age Group

Stroop colour word test (modified Stroop test): participants will be asked to name the colour of ink that each word is printed in. This test will appear on the mobile phone in their hands while they walk to increase the effect of cognitive loading.

Fifth Age GroupFirst Age GroupFourth Age GroupSecond Age GroupThird Age Group

Participants will be asked to hold a tray of glasses filled with water and walk 10 meters to calculate the effect of cognitive loading on gait.

Fifth Age GroupFirst Age GroupFourth Age GroupSecond Age GroupThird Age Group

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female genders.
  • Age between 21-70 years.
  • Healthy individuals with normal systemic history.
  • Individuals with normal cognitive level (score between 0-7 on 6CIT test)

You may not qualify if:

  • Individuals having any comorbidities.
  • Individuals having diagnosed gait disorders/deviations.
  • Non-cooperative participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: research
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 24, 2024

Study Start

October 24, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations