Stress Modulation and Dynamic Balance

N/ANot Yet RecruitingNCT07571369

Kafrelsheikh University72 enrolled

Overview

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.

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.

Interventions

Dynamic Balance Training OnlyOTHER

Participants perform a structured set of dynamic balance exercises under single-task conditions (motor task only). Exercises include: 1. 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. 2. 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. 3. 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. 4. Single-Leg Lateral Reach (SLSR): Same as SLFR but reaching sideways (lateral abduction). 10 repetitions per leg. 5. 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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Balance check 636

Time frame: baseline and at 6 weeks post-treatment

PERCEIVED SRESS SCALE

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.