- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06656078
Comparison of Effect of Different Methods of Cognitive Loading on Gait of Normal Healthy Students
The Effects of Different Types of Cognitive Load on Gait
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Islamabad, Punjab, Pakistan, 44030
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female students from colleges of Abbottabad.
- Age limit (17 to 20) According to (FSC admission criteria age of the student should not be more than 18 to enter the college.)
- Healthy individuals without any neurological and MSK disorder. (screening will be done before performing the test on the student, questions regarding the above-mentioned conditions and consent will be signed before starting the test)
Exclusion Criteria:
- Any student with visible physical deformity or MSK disorder will not be included in this research (15)
- Any student with a psychiatric or neurological disorder will not be included (16)
- Any student with cardiac abnormality will be excluded from this research (17)
- Any student who does not fall in this age group will not be included in this research.
- Colleges outside Abbottabad will not be included in this research.
Study Plan
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: Group 1 male
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 applied three times with pre and post-recordings to ensure reliability. |
Arithmetic task: backward counting with serial 3 subtractions out loud.
Group 1 and Group 2 participants will be asked to count backwards with serial 3 subtractions out loud while walking 10 meters.
There is considerable disruption of performance because of simultaneous articulatory suppression.
However, when errors were observed they were calculated to be numerically close to the correct figure which suggests that performance was not completely disrupted by suppression of articulation.
Modified Stroop test or Stroop colour word test: Participants are asked to name the colour of ink that each word is printed.
It is the most frequent test used to show attention bias in anxiety patients.
This test will appear on the mobile phone in their hands while they walk to increase the effect of cognitive loading.
Carrying a tray with four glasses filled with water.
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: Group 2 female
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 applied three times along with pre and post-recordings to ensure reliability. |
Arithmetic task: backward counting with serial 3 subtractions out loud.
Group 1 and Group 2 participants will be asked to count backwards with serial 3 subtractions out loud while walking 10 meters.
There is considerable disruption of performance because of simultaneous articulatory suppression.
However, when errors were observed they were calculated to be numerically close to the correct figure which suggests that performance was not completely disrupted by suppression of articulation.
Modified Stroop test or Stroop colour word test: Participants are asked to name the colour of ink that each word is printed.
It is the most frequent test used to show attention bias in anxiety patients.
This test will appear on the mobile phone in their hands while they walk to increase the effect of cognitive loading.
Carrying a tray with four glasses filled with water.
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 (m/s)
Time Frame: Baseline
|
For gait activity, the Gait and Balance mobile app (G&B) measures the walking speed with moderate to excellent reliability while the participant is walking normally with (ICC=0.93).
Walking speed usually decreases if the participant performs a task that challenges dynamic balance.
|
Baseline
|
|
Walking speed (m/s)
Time Frame: During Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures the walking speed with moderate to excellent reliability while the participant is walking normally with (ICC=0.93).
Walking speed usually decreases if the participant performs a task that challenges dynamic balance.
|
During Cognitive loading tests
|
|
Walking speed (m/s)
Time Frame: Immediately after Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures the walking speed with moderate to excellent reliability while the participant is walking normally with (ICC=0.93).
Walking speed usually decreases if the participant performs a task that challenges dynamic balance.
|
Immediately after Cognitive loading tests
|
|
Gait symmetry (%)
Time Frame: Baseline
|
For gait activity, the Gait and Balance mobile app (G&B) measures gait symmetry with moderate to excellent reliability while the participant is walking normally with (ICC=0.65)
Gait symmetry tends to decrease if the participant undergoes a task that includes dynamic balance.
|
Baseline
|
|
Gait symmetry (%)
Time Frame: During Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures gait symmetry with moderate to excellent reliability while the participant is walking normally with (ICC=0.65)
Gait symmetry tends to decrease if the participant undergoes a task that includes dynamic balance.
|
During Cognitive loading tests
|
|
Gait symmetry (%)
Time Frame: Immediately after Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures gait symmetry with moderate to excellent reliability while the participant is walking normally with (ICC=0.65)
Gait symmetry tends to decrease if the participant undergoes a task that includes dynamic balance.
|
Immediately after Cognitive loading tests
|
|
Step length(m)
Time Frame: Baseline
|
For gait activity, the Gait and Balance mobile app (G&B) measures step length with moderate to excellent reliability while the participant is walking normally with (ICC=0.94).
Step length usually increases with challenged dynamic balance-based activities.
|
Baseline
|
|
Step length(m)
Time Frame: During Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step length with moderate to excellent reliability while the participant is walking normally with (ICC=0.94).
Step length usually increases with challenged dynamic balance-based activities.
|
During Cognitive loading tests
|
|
Step length(m)
Time Frame: Immediately after Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step length with moderate to excellent reliability while the participant is walking normally with (ICC=0.94).
Step length usually increases with challenged dynamic balance-based activities.
|
Immediately after Cognitive loading tests
|
|
Step time(s)
Time Frame: Baseline
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time with moderate to excellent reliability while the participant is walking normally with (ICC=0.84).
Step time increases under the effect of dynamic balance-based activities.
|
Baseline
|
|
Step time(s)
Time Frame: During Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time with moderate to excellent reliability while the participant is walking normally with (ICC=0.84).
Step time increases under the effect of dynamic balance-based activities.
|
During Cognitive loading tests
|
|
Step time(s)
Time Frame: Immediately after Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time with moderate to excellent reliability while the participant is walking normally with (ICC=0.84).
Step time increases under the effect of dynamic balance-based activities.
|
Immediately after Cognitive loading tests
|
|
Step time variability(%)
Time Frame: Baseline
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time with moderate to poor reliability while the participant is walking normally (ICC=0.51).
Step time variability tends to increase if a participant undergoes dynamic balance-based activities.
|
Baseline
|
|
Step time variability(%)
Time Frame: During Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time with moderate to poor reliability while the participant is walking normally (ICC=0.51).
Step time variability tends to increase if a participant undergoes dynamic balance-based activities.
|
During Cognitive loading tests
|
|
Step time variability(%)
Time Frame: Immediately after Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time with moderate to poor reliability while the participant is walking normally (ICC=0.51).
Step time variability tends to increase if a participant undergoes dynamic balance-based activities.
|
Immediately after Cognitive loading tests
|
|
Step length variability(%)
Time Frame: Baseline
|
For gait activity, the G&B app measures step length variability with moderate to poor reliability while the participant is walking normally (ICC=0.16).
step length variability tends to increase with activities that involve dynamic balance.
|
Baseline
|
|
Step length asymmetry(%)
Time Frame: During Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step length asymmetry with moderate to poor reliability while the participant is walking normally with (ICC=0.6).
Step length asymmetry tends to increase with tasks that include dynamic balance.
|
During Cognitive loading tests
|
|
Step length asymmetry(%)
Time Frame: Immediately after Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step length asymmetry with moderate to poor reliability while the participant is walking normally with (ICC=0.6).
Step length asymmetry tends to increase with tasks that include dynamic balance.
|
Immediately after Cognitive loading tests
|
|
Step time asymmetry(%)
Time Frame: Baseline
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time asymmetry with moderate reliability while the participant is walking normally with (ICC=0.68).
Step time asymmetry tends to increase with activities that include dynamic balance.
|
Baseline
|
|
Step time asymmetry(%)
Time Frame: During Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time asymmetry with moderate reliability while the participant is walking normally with (ICC=0.68).
Step time asymmetry tends to increase with activities that include dynamic balance.
|
During Cognitive loading tests
|
|
Step time asymmetry(%)
Time Frame: Immediately after Cognitive loading tests
|
For gait activity, the Gait and Balance mobile app (G&B) measures step time asymmetry with moderate reliability while the participant is walking normally with (ICC=0.68).
Step time asymmetry tends to increase with activities that include dynamic balance.
|
Immediately after Cognitive loading tests
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Imran Amjad, Phd, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/01885 Imran Amjad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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