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NCT Number: NCT07571369

Stress Modulation and Dynamic Balance

This three-arm, parallel-group, randomized controlled trial (RCT) investigates whether dual-task therapeutic exercises (dynamic balance + cognitive task) improve perceived stress and dynamic balance in 72 healthy university students (18-25 years) compared to traditional balance training alone or a control group receiving general health advice. The dual-task group performs the same dynamic balance exercises (e.g., backward walking, tandem gait, single-leg reaches) while simultaneously engaging in cognitive tasks (verbal fluency, arithmetic, or working memory). The intervention lasts 6 weeks (2 sessions/week, 20-30 min each). Primary outcomes are Perceived Stress Scale (PSS-10) scores and objective dynamic balance indices (anterior/posterior/lateral deviation, overall stability) measured via the Balance check 636 device. Assessments occur at baseline and post-intervention by a blinded assessor. The study addresses a gap: no prior trial has examined combined effects of dual-task training on both stress modulation and balance in this population.

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Study Design

  • Type: Pre-post RCT, three parallel groups (n=24 each).
  • Setting: Outpatient Clinic & Balance Laboratory, Faculty of Physical Therapy, Kafr Elsheikh University.
  • Blinding: Assessor blinded to group allocation.

Population & Eligibility

  • Sample: 72 students (both sexes), age 18-25, BMI 18.5-29.9.
  • Inclusion: Free from neurological, musculoskeletal, or psychiatric disorders; willing to comply.
  • Exclusion: Lower limb/spine injury/surgery (past 6 months), vestibular disorders, pregnancy, medications affecting balance/cognition, regular balance or mind-body training in past 6 months.

Randomization & Groups

  • Computer-generated block randomization with opaque sealed envelopes.
  • Group A (Balance only): dynamic balance exercises (backward walking, lateral stepping, single-leg forward/lateral reach, tandem gait).
  • Group B (Dual-task): same balance exercises plus concurrent cognitive tasks: verbal fluency (e.g., name words starting with letter 'S'), arithmetic (e.g., subtract 7 from 100), or working memory (digit span backward). Cognitive tasks varied across sessions.
  • Group C (Control): general health advice (regular daily activities, sleep, nutrition, avoid excessive stress); no structured exercise.

Intervention Protocol

  • Duration: 6 weeks, twice/week, each session 20-30 minutes.
  • Progression Not Explicitly Stated - but exercises are fixed (10 repetitions or 5-10 m distance per item).
  • Safety: Arms crossed over chest in most exercises to eliminate upper limb compensation.

Outcome Measures (assessed at baseline & week 6)

  • Primary - Perceived Stress: Arabic PSS-10 (0-40, higher = worse).
  • Primary - Dynamic Balance: Balance check 636 (multiaxial wobble board with real-time software) - records anterior/posterior/right/left average deviations and overall stability index.
  • Anthropometric: Weight, height, BMI via standard scale.

Statistical Analysis

  • Software: SPSS v26.
  • Normality: Shapiro-Wilk test.
  • Within-group: Paired t-test or Wilcoxon signed-rank.
  • Between-groups (post-intervention): One-way ANOVA or Kruskal-Wallis; post-hoc with Bonferroni.
  • Power: G*Power (α=0.05, power=0.9, effect size 0.46) → n=72 (24/group, allowing 10% dropout).
  • Significance level: p < 0.05.

Hypotheses (Null)

  • No significant effect of dual-task exercises on stress modulation or dynamic balance.
  • No significant difference between dual-task and balance-only groups.

Limitations Noted in Protocol

  • No long-term follow-up.
  • Single-site, student population (limited generalizability).
  • No objective stress biomarker (only self-report PSS).

Timeline & Ethics

  • Participants sign informed consent (Helsinki protocol). Voluntary withdrawal allowed without justification.
  • Study period: not explicitly dated; protocol submitted 2026 for master's degree.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will be included if they meet the following criteria:

Age between 18 and 25 years. Body Mass Index (BMI) ranging from 18.5 to 29.9 kg/m². Both males and females. Apparently healthy individuals with no diagnosed neurological, musculoskeletal, or psychological disorders.

Ability to understand instructions and provide informed consent. Willingness to participate and comply with the study protocol.

Exclusion criteria

  • Participants will be excluded if they have any of the following:

Any neurological disorder affecting balance (e.g., vestibular disorders, Parkinson's disease, multiple sclerosis, peripheral neuropathy).

Any recent musculoskeletal injury (within the last 6 months) affecting the lower limbs or spine.

History of lower limb or spinal surgery. Severe visual or auditory impairment not corrected by aids. Use of medications that may affect balance or cognitive function (e.g., sedatives, antidepressants, anxiolytics, antipsychotics).

Pregnancy. Uncontrolled cardiovascular or respiratory disorders limiting exercise tolerance.

Current diagnosis of major psychiatric disorders (e.g., major depression, generalized anxiety disorder, panic disorder).

Regular participation in balance training, mind-body exercises (e.g., yoga, Pilates, tai chi), or structured stress management programs within the last 6 months.

Participation in another interventional study at the same time.

Treatment and study plan

Dynamic Balance Training Only

Other

Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include:

  • Controlled Backward Walking (CBW): Walk backward in a straight line (5-10 meters) using a toe-heel strike pattern; maintain upright trunk, head forward, arms naturally at sides.
  • Controlled Lateral Dynamic Stepping (CLDS): Step sideways along a 5-meter path; feet shoulder-width apart, knees slightly flexed, hands clasped at chest; gaze fixed forward.
  • Single-Leg Forward Reach (SLFR): Stand on one limb, hands crossed over chest; reach the non-standing leg forward to touch the floor with toes, return without losing balance. 10 repetitions per leg.
  • Single-Leg Lateral Reach (SLSR): Same as SLFR but reaching sideways (lateral abduction). 10 repetitions per leg.
  • Dynamic Tandem Gait (DTG): Walk heel-to-toe in a straight line (3-5 meters) with hands crossed over chest; gaze fixed forward.

Delivery: In-person, supervised by a trained physical thera

Primary outcomes

  1. Balance check 636

    Time frame: baseline and at 6 weeks post-treatment

  2. PERCEIVED SRESS SCALE

    Time frame: baseline and at 6 weeks post-treatment

    The Perceived Stress Scale (PSS-10) is a 10-item self-report questionnaire designed to measure the degree to which situations in one's life over the past month are appraised as stressful. Items assess feelings of unpredictability, uncontrollability, and overload (e.g., "How often have you felt nervous and stressed?"). Responses are rated on a 5-point Likert scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating higher perceived stress.

Study contacts

Contact information is provided by the study sponsor or research team.

AMMAR GHALLAB, TEACHING ASSISTANT

CONTACT

[email protected]

0201065825099

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Impact of Dual Task Therapeutic Exercises on Stress Modulation and Dynamic Balance in University Students

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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