NCT07006870

Brief Summary

The aim of this study will be to evaluate the effect of adding Virtual reality training to balance exercise program on improving Balance, Postural Stability, mobility and Quality of life in obese patients.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

May 28, 2025

Last Update Submit

April 17, 2026

Conditions

Keywords

Virtual Reality TrainingBalancePostural StabilityQuality of LifeObese

Outcome Measures

Primary Outcomes (1)

  • Single-Leg Stance Test

    Single-Leg Stance Test on Firm and Foam Surfaces Participants were asked to stand on 1 leg with eyes open on firm and foam surfaces for as long as possible; the time in seconds was recorded using a stopwatch. Participants completed 3 trials on each leg, and a mean score was calculated for each leg. Rest was permitted between each trial. The test was terminated when (1) the raised foot touched the stance leg or the floor, (2) the participant hopped, and (3) the arm touched a support surface or the investigator. The dominant leg was indicated by the preferred foot when kicking a ball. This test has shown excellent test-retest reliability among healthy older adults, and predictive validity in older adults with Parkinson disease. A cutoff of \<10 seconds has discriminated between fallers and non-fallers with Parkinson disease

    Eight weeks

Secondary Outcomes (3)

  • Stability Assessment

    Eight weeks.

  • Timed-Up-and-Go Test

    Eight weeks.

  • The Short Form-36 (SF-36) Questionnaire

    Eight weeks

Study Arms (2)

Virtual reality Plus Balance exerciseTraining Group

EXPERIMENTAL

30 patients will receive Virtual reality training in addition to balance exercise program. for 30 minutes, 3 days/ week for 8 weeks.

Other: Virtual Reality plus Balance Exercise TrainingOther: Balance Exercise Training

Balance Training Exercise Program

ACTIVE COMPARATOR

30 patients will receive balance exercise program. for 30 minutes, 3 days/ week for 8 weeks.

Other: Balance Exercise Training

Interventions

Virtual reality balance training will be completed using the BRU system's preloaded programs for postural training and rehabilitation. Rehabilitation exercises will include tasks performed standing with virtual reality headset on whereby the visual and vestibular systems will be stressed and will be customized according to the participant's needs and ability to tolerate the training stimulus. Postural training exercises will be used to develop limits of stability, with 3 exercises performed requiring participants to move their center of mass to collect rings/blocks through a course within a given amount of time. Each of the 3 postural training exercises contained 15 levels of varying difficulty. Sessions will be tailored to everyone, with progression of increasing the level of difficulty or time of exposure for each exercise. Participants at this group will be also participate in a Balance exercise training program for 40 min/3 times per week for 8 weeks.

Virtual reality Plus Balance exerciseTraining Group

Each session of balance exercises will be composed of three phases, including warm-up, balance training and cool down. The warm-up phase will involve gentle stretching for calf, hamstring, quadriceps, iliopsoas muscles, as well as anterior, posterior and lateral step-ups for 5-10 minutes. The active phase will be performed on a balance training for 20 minutes. It included heel and toe raises, one-legged stance for each extremity, shifting weight anteriorly, posteriorly, laterally and diagonally, step-ups, narrow walking, backward walking, sideward walking, stepping over obstacles, passing balls arranged on the training mat in a circle, and throwing and catching a ball on the training mat. A rest period of 1 minute will be given between each component. The program will be ended with 5-10 minutes of cool down. During the cool-down phase, patients will perform deep breathing exercises and static exercises for back extensors in a recumbent position.

Balance Training Exercise ProgramVirtual reality Plus Balance exerciseTraining Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with 20 to 40 years old,
  • Participants with BMI of 30 to 39.9 kg/m2
  • Absence of neurological disorders i.e.: stroke, ataxia, or parkinsonism.

You may not qualify if:

  • Participants with vestibular or vision problem.
  • Participants with Diabetes mellitus or cardiorespiratory disorders.
  • Participants with severe obesity BMI ≥40.
  • participants at regular physical therapy exercise training program at the last 3 months.
  • Participants who are unable to follow instructions due to personal or cognitive problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo university

Cairo, Giza Governorate, 11432, Egypt

Location

Related Publications (4)

  • Sadeghi H, Jehu DA, Daneshjoo A, Shakoor E, Razeghi M, Amani A, Hakim MN, Yusof A. Effects of 8 Weeks of Balance Training, Virtual Reality Training, and Combined Exercise on Lower Limb Muscle Strength, Balance, and Functional Mobility Among Older Men: A Randomized Controlled Trial. Sports Health. 2021 Nov-Dec;13(6):606-612. doi: 10.1177/1941738120986803. Epub 2021 Feb 13.

  • Fang Q, Ghanouni P, Anderson SE, Touchett H, Shirley R, Fang F, Fang C. Effects of Exergaming on Balance of Healthy Older Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Games Health J. 2020 Feb;9(1):11-23. doi: 10.1089/g4h.2019.0016. Epub 2019 Dec 3.

  • Anastasiadou D, Herrero P, Garcia-Royo P, Vazquez-De Sebastian J, Slater M, Spanlang B, Alvarez de la Campa E, Ciudin A, Comas M, Ramos-Quiroga JA, Lusilla-Palacios P. Assessing the Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity: Randomized Controlled Trial. J Med Internet Res. 2024 Apr 5;26:e51558. doi: 10.2196/51558.

  • Greco G, Poli L, Gabriele M, Aidar FJ, Fischetti F, Patti A, Cataldi S. Effectiveness of a 5-week virtual reality versus traditional training on balance and flexibility in healthy adult females. Sport Sciences for Health. 2025 Mar;21(1):289-300.

    RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Access Criteria
After 6 months of publication

Locations