NCT06656078

Brief Summary

Comparison of effect of different methods of cognitive loading on gait of normal healthy students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 8, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

October 8, 2024

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (21)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Immediately after Cognitive loading tests

Study Arms (2)

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.

Other: 1. WORKING MEMORY TASK:Other: 2. VISUAL AND VERBAL FLUENCY TASKOther: 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.

Other: 1. WORKING MEMORY TASK:Other: 2. VISUAL AND VERBAL FLUENCY TASKOther: 3. MOTOR TASK:

Interventions

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.

Group 1 maleGroup 2 female

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.

Group 1 maleGroup 2 female

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.

Group 1 maleGroup 2 female

Eligibility Criteria

Age17 Years - 20 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll male and female healthy students are eligible to participate.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Islamabad, Punjab Province, 44030, Pakistan

Location

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 24, 2024

Study Start

October 24, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations