- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06656052
Effects of Different Types of Cognitive Loading on Gait With Growing Age
January 10, 2025 updated by: Riphah International University
To Determine the Effects of Different Types of Cognitive Loading on Gait With Growing Age
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:
- There is a significant difference in the effect of three different methods of cognitive loading on gait parameters across age groups.
- There is an association of cognitive loading with different age groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Riphah International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Individuals having any comorbidities.
- Individuals having diagnosed gait disorders/deviations.
- Non-cooperative participants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: First Age Group
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.
|
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.
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.
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.
|
|
Experimental: Second Age Group
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.
|
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.
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.
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.
|
|
Experimental: Third Age Group
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.
|
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.
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.
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.
|
|
Experimental: Fourth Age Group
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.
|
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.
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.
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.
|
|
Experimental: Fifth Age Group
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking speed
Time Frame: Baseline
|
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
Time Frame: During three cognitive tasks
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
Time Frame: Baseline
|
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
Time Frame: During Cognitive loading tests
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
Time Frame: Baseline
|
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
Time Frame: During Cognitive loading tests
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
Time Frame: Baseline
|
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
Time Frame: During Cognitive loading tests
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
Time Frame: Baseline
|
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
Time Frame: During Cognitive loading tests
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
Time Frame: Baseline
|
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
Time Frame: During Cognitive loading tests
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
Time Frame: Baseline
|
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
Time Frame: During Cognitive loading tests
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
Time Frame: Baseline
|
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
Time Frame: During Cognitive loading tests
|
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
Time Frame: Immediately after Cognitive loading tests
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Imran Amjad, Phd, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2024
Primary Completion (Actual)
December 30, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
October 8, 2024
First Submitted That Met QC Criteria
October 23, 2024
First Posted (Actual)
October 24, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 10, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/01884 Imran Amjad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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