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临床试验/NCT07571369
NCT07571369尚未招募不适用

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

Kafrelsheikh University0 个研究点目标入组 72 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
主要终点
Balance check 636

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: Dynamic Balance Training Only (Other)

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

干预措施: Dynamic Balance Training Only (Other)

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.

结局指标

主要结局

Balance check 636

时间窗: baseline and at 6 weeks post-treatment

PERCEIVED SRESS SCALE

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ammar Sobhy Farag Ghallab

Teaching assistant

Kafrelsheikh University

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