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Gait AnalysisNCT06656052

Effects of Different Types of Cognitive Loading on Gait With Growing Age

A study testing 1. working memory task., 2. Visual and Verbal Fluency Task and 3. Motor Task in people with Gait Analysis and Cognitive Load, Performance, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. There is a significant difference in the effect of three different methods of cognitive loading on gait parameters across age groups. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Gait Analysis, Cognitive Load, Performance
What is being tested?
1. working memory task., 2. Visual and Verbal Fluency Task and 3. Motor Task
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 sitePakistan
Study dates
24 Oct 2024to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: 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:

  1. There is a significant difference in the effect of three different methods of cognitive loading on gait parameters across age groups.
  2. There is an association of cognitive loading with different age groups.
Being tested
1. working memory task., 2. Visual and Verbal Fluency Task, 3. Motor Task
Keywords
gait, cognitive load, cognitive loading

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1. working memory task.Other

    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.

  • 2. Visual and Verbal Fluency TaskOther

    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.

  • 3. Motor TaskOther

    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.

Study groups in NCT06656052
Study groupRoleWhat they receive
First Age GroupExperimentalParticipants 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.
Receives: Other: 1. working memory task.; Other: 2. Visual and Verbal Fluency Task; Other: 3. Motor Task
Second Age GroupExperimentalParticipants 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.
Receives: Other: 1. working memory task.; Other: 2. Visual and Verbal Fluency Task; Other: 3. Motor Task
Third Age GroupExperimentalParticipants 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.
Receives: Other: 1. working memory task.; Other: 2. Visual and Verbal Fluency Task; Other: 3. Motor Task
Fourth Age GroupExperimentalParticipants 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.
Receives: Other: 1. working memory task.; Other: 2. Visual and Verbal Fluency Task; Other: 3. Motor Task
Fifth Age GroupExperimentalParticipants 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.
Receives: Other: 1. working memory task.; Other: 2. Visual and Verbal Fluency Task; Other: 3. Motor Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: During three cognitive tasks

  3. 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.

    Measured: Immediately after Cognitive loading tests

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: During Cognitive loading tests

  6. 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.

    Measured: Immediately after Cognitive loading tests

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: During Cognitive loading tests

  9. 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.

    Measured: Immediately after Cognitive loading tests

  10. 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.

    Measured: Baseline

  11. 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.

    Measured: During Cognitive loading tests

  12. 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.

    Measured: Immediately after Cognitive loading tests

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: During Cognitive loading tests

  15. 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.

    Measured: Immediately after Cognitive loading tests

  16. 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.

    Measured: Baseline

  17. 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.

    Measured: During Cognitive loading tests

  18. 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.

    Measured: Immediately after Cognitive loading tests

  19. 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.

    Measured: Baseline

  20. 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.

    Measured: During Cognitive loading tests

  21. 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.

    Measured: Immediately after Cognitive loading tests

  22. 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.

    Measured: Baseline

  23. 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.

    Measured: During Cognitive loading tests

  24. 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.

    Measured: Immediately after Cognitive loading tests

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start24 Oct 2024
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
research
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656052
Sponsor's protocol ID
REC/01884 Imran Amjad
Status last verified
Jan 2025
First submitted
8 Oct 2024
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 1. working memory task., 2. Visual and Verbal Fluency Task and 3. Motor Task in people with Gait Analysis and Cognitive Load, Performance, run by Riphah International University at 1 site in Pakistan.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jan 2025. 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking speed (time frame: Baseline). The study lists 24 primary outcomes in all. 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 13 Jan 2025.

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