NCT07841379

Brief Summary

This study investigates whether stepping training that uses an unpredictable, variable auditory cue - changing both the timing and the direction of each step - improves dynamic balance and stepping adaptability more than stepping training with a constant, predictable auditory cue. Sedentary young adults will be randomly assigned to one of two 4-week training programs and assessed before and after training.

Trial Health

65
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Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet 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

Study Progress94%
Sep 2026Oct 2026

First Submitted

Initial submission to the registry

September 7, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 8, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2026

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

28 days

First QC Date

September 7, 2026

Last Update Submit

September 20, 2026

Conditions

Keywords

auditory cueingstepping trainingdynamic balancestepping adaptabilitymotor learningcontextual interferencesedentary young adultrehabilitation

Outcome Measures

Primary Outcomes (3)

  • Change in Y-Balance Test Composite Reach Score

    Dynamic balance assessed using the Y-Balance Test, with composite reach score (anterior, posteromedial, posterolateral directions) normalized to limb length and expressed as a percentage.

    Baseline and 4 weeks

  • Change in Choice Stepping Reaction Time

    Stepping adaptability assessed using Choice Stepping Reaction Time, measured as mean reaction time in milliseconds in response to randomized directional auditory cues.

    Baseline and 4 weeks

  • Change in Choice Stepping Reaction Time

    Stepping adaptability assessed using Choice Stepping Reaction Time, measured as accuracy (percentage of correct responses) in response to randomized directional auditory cues.

    Baseline and 4 weeks

Secondary Outcomes (3)

  • Change in Four Square Step Test Time

    Baseline and 4 weeks

  • Change in Timed Up and Go Test Time

    Baseline and 4 weeks

  • Change in Berg Balance Scale Score

    Baseline and 4 weeks

Study Arms (2)

Variable Cueing Group

EXPERIMENTAL

Participants will receive auditory-cued stepping training with randomly varying inter-stimulus timing (1.5-3.5 seconds) and randomly varying step direction (anterior, posterior, lateral), 3 sessions/week for 4 weeks.

Behavioral: Variable-Timing, Variable-Direction Auditory-Cued Stepping Training

Fixed Cueing Group

ACTIVE COMPARATOR

Participants will receive auditory-cued stepping training with constant, fixed inter-stimulus timing (every 2.5 seconds) and a single, fixed step direction (forward only), 3 sessions/week for 4 weeks, matched for total training volume with the Variable Cueing Group.

Behavioral: Fixed-Timing, Fixed-Direction Auditory-Cued Stepping Training

Interventions

A supervised stepping-training program delivered 3 sessions/week for 4 weeks (12 sessions total). Each session includes a 5-minute warm-up, 20-25 minutes of auditory-cued stepping training, and a 5-minute cool-down. During the main training phase, participants respond to auditory cues with randomly varying inter-stimulus timing (1.5-3.5 seconds) and randomly varying step direction (anterior, posterior, lateral), stepping onto the cued target as quickly as possible before returning to a central start position.

Variable Cueing Group

A supervised stepping-training program delivered 3 sessions/week for 4 weeks (12 sessions total), identical in structure, duration, and total training volume to the Variable Cueing Group. During the main training phase, participants respond to auditory cues delivered at a constant, fixed inter-stimulus interval (every 2.5 seconds) and a single, fixed step direction (forward only), stepping onto the fixed target before returning to a central start position.

Fixed Cueing Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • Sedentary lifestyle (International Physical Activity Questionnaire short-form 'inactive/low' category, or \<150 minutes/week of moderate-to-vigorous physical activity)
  • Able to stand and walk independently without an assistive device
  • Normal or corrected-to-normal hearing and vision
  • Body Mass Index (BMI) 18.5-29.9 kg/m²
  • Willing and able to provide written informed consent and comply with the 4-week training schedule and assessment sessions

You may not qualify if:

  • Diagnosed neurological, vestibular, or orthopedic/musculoskeletal condition known to affect balance or gait (e.g., stroke, Parkinson's disease, vestibular disorders, lower-limb fracture/surgery in the past 6 months)
  • History of falls within the past 12 months
  • Hearing impairment or use of a hearing aid/cochlear implant
  • Uncorrected visual impairment
  • Regular participation in structured exercise, sport, or balance/agility training (\>150 min/week of moderate-to-vigorous activity)
  • Pregnancy
  • Cardiovascular, respiratory, or other medical contraindication to physical exertion/exercise testing
  • Current use of medication known to affect balance, reaction time, or central nervous system function (e.g., sedatives, anti-vertigo medication)
  • Cognitive or communication impairment that would limit the ability to follow auditory-cued instructions
  • Concurrent enrollment in another balance, stepping, or exercise-intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Beshoy Maher Rezk Hanna

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 25, 2026

Study Start

September 8, 2026

Primary Completion (Estimated)

October 6, 2026

Study Completion (Estimated)

October 6, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share