NCT07571369

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Oct 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

First Submitted

Initial submission to the registry

April 24, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 24, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Balance check 636

    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.

    baseline and at 6 weeks post-treatment

Study Arms (3)

Dynamic Balance Training Only

ACTIVE COMPARATOR

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 ther

Other: Dynamic Balance Training Only

Dual task therapeutic exercises

EXPERIMENTAL

Arm B: Dual-Task Therapeutic Exercise Group Intervention Type: Other (Dual-Task Training) Intervention Name: Dual-Task Therapeutic Exercise Description: Participants perform exactly the same dynamic balance exercises as Arm A, but simultaneously with a secondary cognitive task (dual-task condition). The cognitive task is performed throughout the duration of each balance exercise. Cognitive tasks are varied across sessions to maintain engagement and avoid habituation, and include: * Verbal Fluency Task: e.g., "Name as many words as you can starting with the letter 'S'" or "Name as many animals/fruits/cities." * Arithmetic Task: e.g., "Count backwards from 100 by 7" or "Subtract 3 from 50, then 3 from that number, and so on." * Working Memory Task: The therapist reads a list of numbers or words; the participant recalls them in reverse order (digits backward). Delivery: In-person, supervised by the same trained physical therapist as Arm A. Frequency \& Duration: Twice weekly for 6

Other: Dynamic Balance Training Only

General Health Advice

NO INTERVENTION

Participants in this arm receive no active intervention (no dynamic balance training or dual-task exercises). They are provided with general health advice and educational brochures about fall prevention and physical activity, but no structured exercise program is prescribed. They are asked to maintain their usual daily activities and are followed up at the same time points as the intervention groups.

Interventions

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

Dual task therapeutic exercisesDynamic Balance Training Only

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • MAHMOUD EWIDA, PROFESSOR

    Kafr Elsheikh University, Faculty of Physical Therapy, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AMMAR GHALLAB, TEACHING ASSISTANT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 6, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share