- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06941714
Cognitive Load Effects on Balance and Postural Stability in Young Adults
Evaluating the Effects of Cognitive Load on Postural Stability and Balance Recovery Mechanisms in Younger Adults
- The aim is to determine the impact of cognitive load on balance recovery mechanisms following perturbations in young adults.
- To evaluate how secondary task is influenced by cognitive load and vice versa.
- To compare the impact of cognitive load on balance recovery mechanisms following perturbations in male and female young adults.
- This study interrelates the cognitive load, postural stability, balance recovery in the result of perturbation and effects on participants.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Recruiting
- Riphah International University
-
Contact:
- imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Participants between age of 18 to 30 (university Students)
- Sufficient physical function to stand independently.
- Self-reported independent ambulation.
- Participant willingness to participate.
Exclusion Criteria:
- History of neurological or vestibular disorders.
- Self-reported presence of musculoskeletal condition.
- Disorders of spine, pelvic girdle and lower limb.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Baseline Balance Assessment
All participants who fall in the eligibility criteria will stand on force plates to check the static balance.
|
|
|
Experimental: Static Balance along with Cognitive Loading
All participants who fall in the eligibility criteria will stand on force plates to check static balance and undergo two different types of cognitive loading
|
Arithmetic test (Backward counting with serial 3 subtraction and articulation): participants are asked to count out loud backward with serial subtraction of 3 from each number, starting with a random number provided by the researcher.
while participants are standing on force plates.
During all this process cognitive loading will be measured through Heart Rate Variability (HRV) and Galvanic Skin Response (GSR).
Modified Stroop test or Stroop color word test: Participants are asked to name the color of ink that each word is printed.
The test will appear on screen while participants are standing on force plates.
During all this process cognitive loading will be measured through Heart Rate Variability (HRV) and Galvanic Skin Response (GSR).
|
|
Experimental: Perturbation
All participants who fall in the eligibility criteria will stand on force plate and perturbation is given to check balance recovery.
|
Jack is attached to force plates and it is used to give perturbation when participants are standing on force platform.
Balance is assessed after perturbation and readings will be taken through HRV and GSR.
|
|
Experimental: Perturbation along with Cognitive Loading
All participants who fall in the eligibility criteria will stand on force plate and perturbation is given to check balance recovery and undergo two different types of cognitive loading.
|
Arithmetic test (Backward counting with serial 3 subtraction and articulation): participants are asked to count out loud backward with serial subtraction of 3 from each number, starting with a random number provided by the researcher.
while participants are standing on force plates.
During all this process cognitive loading will be measured through Heart Rate Variability (HRV) and Galvanic Skin Response (GSR).
Modified Stroop test or Stroop color word test: Participants are asked to name the color of ink that each word is printed.
The test will appear on screen while participants are standing on force plates.
During all this process cognitive loading will be measured through Heart Rate Variability (HRV) and Galvanic Skin Response (GSR).
Jack is attached to force plates and it is used to give perturbation when participants are standing on force platform.
Balance is assessed after perturbation and readings will be taken through HRV and GSR.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Centre of Pressure
Time Frame: Baseline
|
Force plates are used to measure data quantitatively and analyze postural stability through the displacement of COP from forces and moments.
A force platform is used in conditions when the force platform is not moving (static posturography) and when the force platform is moving (dynamic posturography).
It has the capability of measuring ground reaction forces in three directions and the moment of force.
Each of the platforms was connected to a dedicated computer with relevant software and valid controllers.
|
Baseline
|
|
Centre of Pressure (2nd reading)
Time Frame: Periprocedural
|
Force plates are used to measure data quantitatively and analyze postural stability through the displacement of COP from forces and moments. A force platform is used in conditions when the force platform is not moving (static posturography) and when the force platform is moving (dynamic posturography). It has the capability of measuring ground reaction forces in three directions and the moment of force. Each of the platforms was connected to a dedicated computer with relevant software and valid controllers. 2nd reading will be taken to measure static balance along with cognitive loading. |
Periprocedural
|
|
Centre of Pressure (3rd reading)
Time Frame: Periprocedural
|
Force plates are used to measure data quantitatively and analyze postural stability through the displacement of COP from forces and moments. A force platform is used in conditions when the force platform is not moving (static posturography) and when the force platform is moving (dynamic posturography). It has the capability of measuring ground reaction forces in three directions and the moment of force. Each of the platforms was connected to a dedicated computer with relevant software and valid controllers. 3rd reading will be taken at the time of perturbation without cognitive loading. |
Periprocedural
|
|
Centre of Pressure (4rth reading)
Time Frame: Periprocedural
|
Force plates are used to measure data quantitatively and analyze postural stability through the displacement of COP from forces and moments. A force platform is used in conditions when the force platform is not moving (static posturography) and when the force platform is moving (dynamic posturography). It has the capability of measuring ground reaction forces in three directions and the moment of force. Each of the platforms was connected to a dedicated computer with relevant software and valid controllers. 4rth reading will be taken at the time of perturbation along with cognitive loading. |
Periprocedural
|
|
Postural Sway
Time Frame: Baseline
|
It is assessed through a force plate when the subject is standing on it.
|
Baseline
|
|
Postural Sway (2nd reading)
Time Frame: Periprocedural
|
It is assessed through a force plate when the subject is standing on it.
2nd reading will be taken to measure static balance along with cognitive loading.
|
Periprocedural
|
|
Postural Sway (3rd reading)
Time Frame: Periprocedural
|
It is assessed through a force plate when the subject is standing on it.
3rd reading will be taken at the time of perturbation without cognitive loading.
|
Periprocedural
|
|
Postural Sway (4rth reading)
Time Frame: Periprocedural
|
It is assessed through a force plate when the subject is standing on it.
4rth reading will be taken at the time of perturbation along with cognitive loading.
|
Periprocedural
|
|
Balance Recovery
Time Frame: Periprocedural
|
Jack is attached to force plates, and it is used to give a perturbation when the participant is standing on the force platform, and balance is assessed after the participant recovers from the perturbation.
1st reading will be taken to measure static balance without cognitive loading.
|
Periprocedural
|
|
Balance Recovery (2nd reading)
Time Frame: Periprocedural
|
Jack is attached to force plates, and it is used to give a perturbation when the participant is standing on the force platform, and balance is assessed after the participant recovers from the perturbation.
2nd reading will be taken to measure static balance along with cognitive loading.
|
Periprocedural
|
|
Heart Rate Variability
Time Frame: Baseline
|
Heart Rate Variability is a beat-to-beat fluctuation in normal sinus rhythm, and it arises due to variation between the sympathetic and parasympathetic divisions of the autonomic nervous system.
Heart Rate Variability (HRV) is measured by using ECG signals.
There is a positive association between HRV indices and cognitive performance.
|
Baseline
|
|
Heart Rate Variability (2nd reading)
Time Frame: Periprocedural
|
Heart Rate Variability is a beat-to-beat fluctuation in normal sinus rhythm, and it arises due to variation between the sympathetic and parasympathetic divisions of the autonomic nervous system.
Heart Rate Variability (HRV) is measured by using ECG signals.
There is a positive association between HRV indices and cognitive performance.
2nd reading will be taken to measure static balance along with cognitive loading.
|
Periprocedural
|
|
Heart Rate Variability (3rd reading)
Time Frame: Periprocedural
|
Heart Rate Variability is a beat-to-beat fluctuation in normal sinus rhythm, and it arises due to variation between the sympathetic and parasympathetic divisions of the autonomic nervous system.
Heart Rate Variability (HRV) is measured by using ECG signals.
There is a positive association between HRV indices and cognitive performance.
3rd reading will be taken at the time of perturbation without cognitive loading.
|
Periprocedural
|
|
Heart Rate Variability (4rth reading)
Time Frame: Periprocedural
|
Heart Rate Variability is a beat-to-beat fluctuation in normal sinus rhythm, and it arises due to variation between the sympathetic and parasympathetic divisions of the autonomic nervous system.
Heart Rate Variability (HRV) is measured by using ECG signals.
There is a positive association between HRV indices and cognitive performance.
4rth reading will be taken at the time of perturbation along with cognitive loading.
|
Periprocedural
|
|
Galvanic Skin Response
Time Frame: Baseline
|
Galvanic Skin Response is used in many psychophysiological studies.
A change in the electrical property of skin is known as the galvanic skin response.
GSR signals are used to capture autonomic nerve responses as a parameter of sweat gland function.
There is a direct relation between GSR reading and cognitive loading.
|
Baseline
|
|
Galvanic Skin Response (2nd reading)
Time Frame: Periprocedural
|
Galvanic Skin Response is used in many psychophysiological studies.
A change in the electrical property of skin is known as the galvanic skin response.
GSR signals are used to capture autonomic nerve responses as a parameter of sweat gland function.
There is a direct relation between GSR reading and cognitive loading.
2nd reading will be taken to measure static balance along with cognitive loading.
|
Periprocedural
|
|
Galvanic Skin Response (3rd reading)
Time Frame: Periprocedural
|
Galvanic Skin Response is used in many psychophysiological studies.
A change in the electrical property of skin is known as the galvanic skin response.
GSR signals are used to capture autonomic nerve responses as a parameter of sweat gland function.
There is a direct relation between GSR reading and cognitive loading.
3rd reading will be taken at the time of perturbation without cognitive loading.
|
Periprocedural
|
|
Galvanic Skin Response (4rth reading)
Time Frame: Periprocedural
|
Galvanic Skin Response is used in many psychophysiological studies.
A change in the electrical property of skin is known as the galvanic skin response.
GSR signals are used to capture autonomic nerve responses as a parameter of sweat gland function.
There is a direct relation between GSR reading and cognitive loading.
4rth reading will be taken at the time of perturbation along with cognitive loading.
|
Periprocedural
|
|
NASA Task Load Index
Time Frame: after static balance with cognitive loading
|
The different dimensions of task load, including mental demand, physical demand, temporal demand, performance, effort and frustration, will be measured subjectively using the NASA Task Load Index(TLX).
Low ratings will typically indicate an increased cognitive load.
1st reading will be taken after measuring static balance along with cognitive loading.
|
after static balance with cognitive loading
|
|
NASA Task Load Index (2nd reading)
Time Frame: after perturbation with cognitive loading.
|
The different dimensions of task load, including mental demand, physical demand, temporal demand, performance, effort and frustration, will be measured subjectively using the NASA Task Load Index(TLX).
Low ratings will typically indicate an increased cognitive load.
2nd reading will be taken after perturbation with cognitive loading.
|
after perturbation with cognitive loading.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Imran Amjad, Phd, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- REC/02023 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
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