NCT06941714

Brief Summary

  • 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

April 23, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 7, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

Performance

Outcome Measures

Primary Outcomes (20)

  • Centre of Pressure

    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)

    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)

    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)

    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

    It is assessed through a force plate when the subject is standing on it.

    Baseline

  • Postural Sway (2nd reading)

    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)

    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)

    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

    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)

    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

    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)

    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)

    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)

    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

    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)

    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)

    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)

    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

    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)

    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.

Study Arms (4)

Baseline Balance Assessment

NO INTERVENTION

All participants who fall in the eligibility criteria will stand on force plates to check the static balance.

Static Balance along with Cognitive Loading

EXPERIMENTAL

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

Other: Working Memory TaskOther: Visual and Verbal Fluency Task

Perturbation

EXPERIMENTAL

All participants who fall in the eligibility criteria will stand on force plate and perturbation is given to check balance recovery.

Other: Perturbation

Perturbation along with Cognitive Loading

EXPERIMENTAL

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.

Other: PerturbationOther: Working Memory TaskOther: Visual and Verbal Fluency Task

Interventions

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.

PerturbationPerturbation along with 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).

Perturbation along with Cognitive LoadingStatic Balance along with Cognitive Loading

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).

Perturbation along with Cognitive LoadingStatic Balance along with Cognitive Loading

Eligibility Criteria

Age18 Years - 30 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll male and female healthy students are eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants between age of 18 to 30 (university Students)
  • Sufficient physical function to stand independently.
  • Self-reported independent ambulation.
  • Participant willingness to participate.

You may not qualify if:

  • History of neurological or vestibular disorders.
  • Self-reported presence of musculoskeletal condition.
  • Disorders of spine, pelvic girdle and lower limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

RECRUITING

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Research
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 24, 2025

Study Start

April 23, 2025

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations