Cognitive Load, PerformanceNCT06656078
Comparison of Effect of Different Methods of Cognitive Loading on Gait of Normal Healthy Students
A study testing 1. WORKING MEMORY TASK:, 2. VISUAL AND VERBAL FLUENCY TASK and 3. MOTOR TASK: in people with Cognitive Load, Performance, run by Riphah International University at 1 site in Pakistan.
Trial summary
Comparison of effect of different methods of cognitive loading on gait of normal healthy students. Read more about this study
- Who is it for?
- Ages 17 to 20 years
- Conditions the study is for
- 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
- 82 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 17 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Islamabad, Punjab Province, 44030
About this study
Official title: The Effects of Different Types of Cognitive Load on Gait
Comparison of effect of different methods of cognitive loading on gait of normal healthy students.
- Conditions
- Cognitive Load, Performance
- Being tested
- 1. WORKING MEMORY TASK:, 2. VISUAL AND VERBAL FLUENCY TASK, 3. MOTOR TASK:
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 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.
2. VISUAL AND VERBAL FLUENCY TASKOther
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.
3. MOTOR TASK:Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 male | Experimental | 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. Receives: Other: 1. WORKING MEMORY TASK:; Other: 2. VISUAL AND VERBAL FLUENCY TASK; Other: 3. MOTOR TASK: |
| Group 2 female | Experimental | 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. 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.
Walking speed (m/s)
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.
Measured: Baseline
Walking speed (m/s)
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.
Measured: During Cognitive loading tests
Walking speed (m/s)
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.
Measured: Immediately after Cognitive loading tests
Gait symmetry (%)
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.
Measured: Baseline
Gait symmetry (%)
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.
Measured: During Cognitive loading tests
Gait symmetry (%)
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.
Measured: Immediately after Cognitive loading tests
Step length(m)
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.
Measured: Baseline
Step length(m)
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.
Measured: During Cognitive loading tests
Step length(m)
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.
Measured: Immediately after Cognitive loading tests
Step time(s)
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.
Measured: Baseline
Step time(s)
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.
Measured: During Cognitive loading tests
Step time(s)
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.
Measured: Immediately after Cognitive loading tests
Step time variability(%)
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.
Measured: Baseline
Step time variability(%)
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.
Measured: During Cognitive loading tests
Step time variability(%)
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.
Measured: Immediately after Cognitive loading tests
Step length variability(%)
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.
Measured: Baseline
Step length asymmetry(%)
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.
Measured: During Cognitive loading tests
Step length asymmetry(%)
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.
Measured: Immediately after Cognitive loading tests
Step time asymmetry(%)
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.
Measured: Baseline
Step time asymmetry(%)
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.
Measured: During Cognitive loading tests
Step time asymmetry(%)
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.
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.
- First posted24 Oct 2024
- Study start24 Oct 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Load, PerformanceStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656078
- Sponsor's protocol ID
- REC/01885 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Types of Cognitive Load on Gait
- ClinicalTrials.gov ID
- NCT06656078
- Acronym / sponsor ID
- REC/01885 Imran Amjad
- Conditions
- Cognitive Load, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of effect of different methods of cognitive loading on gait of normal healthy students.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Research
| Arm | Type | Receives |
|---|---|---|
| Group 1 male | Experimental | Other: 1. WORKING MEMORY TASK:, Other: 2. VISUAL AND VERBAL FLUENCY TASK, Other: 3. MOTOR TASK: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. |
| Group 2 female | Experimental | Other: 1. WORKING MEMORY TASK:, Other: 2. VISUAL AND VERBAL FLUENCY TASK, Other: 3. MOTOR TASK: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. |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. WORKING MEMORY TASK: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. | Other | Group 1 male, Group 2 female |
| 2. VISUAL AND VERBAL FLUENCY TASKModified 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. | Other | Group 1 male, Group 2 female |
| 3. MOTOR TASK: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. | Other | Group 1 male, Group 2 female |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Amjad, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
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 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 3 inclusion and 5 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 (m/s) (time frame: Baseline). The study lists 21 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.