Obesity/TherapyNCT07006870
Virtual Reality Training on Balance, Postural Stability, Mobility and Quality of Life in Obese Patients
A study testing Virtual Reality plus Balance Exercise Training and Balance Exercise Training in people with Obesity/Therapy and Obesity (Body Mass Index >30 kg/m2), run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Obesity/Therapy, Obesity (Body Mass Index >30 kg/m2)
- What is being tested?
- Virtual Reality plus Balance Exercise Training and Balance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jun 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo university
Cairo, Giza Governorate, 11432
About this study
Official title: Impact of Adding Virtual Reality Training to Balance Exercise Training Program on Balance, Postural Stability, Mobility and Quality of Life in Obese Patients, A Prospective Randomized Controlled Trial
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.
- Being tested
- Virtual Reality plus Balance Exercise Training, Balance Exercise Training
- Keywords
- Virtual Reality Training, Balance, Postural Stability, Quality of Life, Obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality plus Balance Exercise TrainingOther
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.
Balance Exercise TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality plus Balance Exercise Training; Other: 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. Receives: Other: Balance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Eight weeks
Secondary outcomes (3)
Stability Assessment
The Biodex Balance System (Biodex Medical System, Inc., Shirley, NY, USA) will be used to measure anteroposterior, mediolateral, and overall stability indices. Postural balance assessment will evaluate the participant's ability to regulate the platform's tilt angle, with deviations from the centre using standard deviation instead of the mean. Each test will last 20 seconds, with a 10-minute rest between three trials. The Biodex Balance System is reported to have high reliability
Measured: Eight weeks.
Timed-Up-and-Go Test
The TUG test involved participants' getting up from a chair, walking 3 meters at a comfortable speed, turning around, walking back to the chair, and sitting down.45 The time in seconds was recorded between when the examiner verbalized "go" and when the participants back touched the backrest of the chair. The average of the 2 experimental trials was used in the analysis. The test has shown high inter- and intrarater reliability,53 as well as discriminative validity in community dwelling and institutionalized older adults.5 A clinical cutoff of ≤12 seconds has been a recognized threshold for normal TUG performance in community-dwelling older adults
Measured: Eight weeks.
The Short Form-36 (SF-36) Questionnaire
It will be used to evaluate quality of life. This instrument assesses eight domains: general health, mental health, physical functioning, role physical, role emotional, body pain, social functioning, and vitality. Scores for each domain range from 0 to 100, with 0 representing the worst and 100 the best quality of life. The SF-36 primarily evaluates physical and mental aspects and has demonstrated validity and reliability in burn survivors
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start17 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity/TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadaya Mosaad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006870
- Sponsor's protocol ID
- 005842
- Status last verified
- Apr 2026
- First submitted
- 28 May 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33583253Fang 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.
PubMed 31800322Anastasiadou 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.
PubMed 38578667Greco 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding Virtual Reality Training to Balance Exercise Training Program on Balance, Postural Stability, Mobility and Quality of Life in Obese Patients, A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07006870
- Acronym / sponsor ID
- 005842
- Keywords
- Virtual Reality Training, Balance, Postural Stability, Quality of Life, Obese
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality Plus Balance exerciseTraining Group | Experimental | Other: Virtual Reality plus Balance Exercise Training, Other: Balance Exercise Training30 patients will receive Virtual reality training in addition to balance exercise program. for 30 minutes, 3 days/ week for 8 weeks. |
| Balance Training Exercise Program | Active comparator | Other: Balance Exercise Training30 patients will receive balance exercise program. for 30 minutes, 3 days/ week for 8 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality plus Balance Exercise TrainingVirtual 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. | Other | Virtual reality Plus Balance exerciseTraining Group |
| Balance Exercise TrainingEach 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. | Other | Balance Training Exercise Program, Virtual reality Plus Balance exerciseTraining Group |
Primary outcome
Single-Leg Stance Test
Time frame: Eight weeks
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
3 secondary outcomes
Stability Assessment
Time frame: Eight weeks.
Timed-Up-and-Go Test
Time frame: Eight weeks.
The Short Form-36 (SF-36) Questionnaire
Time frame: Eight weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 33583253Sadeghi 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.
- Results publication: PubMed 31800322Fang 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.
- Results publication: PubMed 38578667Anastasiadou 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.
- Results publicationGreco 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality plus Balance Exercise Training and Balance Exercise Training in people with Obesity/Therapy and Obesity (Body Mass Index >30 kg/m2), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-Leg Stance Test (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07006870, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.