Virtual RealityNCT07004101
Effect of Virtual Reality Combined With Balance Training on Biodex Balance System in Female With Fibromyalgia
A study testing virtual reality, biodex training and conventional balance exercises in people with Virtual Reality, run by Badr University at 1 site in Egypt.
Trial summary
Is there an effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia . Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- virtual reality, biodex training and conventional balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 31 Oct 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 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women patients from age 35 to 50 years old
- All patients describe a history of pain spreading in all quadrants of the body for at least three months and pain is caused by digital pressure in at least 11 out of 18 allogenic points, called tender points
Who cannot join
- Old neglected fracture
- Malignant diseases
- Neurological diseases.
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality-based Therapy Combined With Balance Training on Biodex Balance System in Female Patients With Fibromyalgia
Is there an effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .
Read the detailed description
PURPOSE: To Study the Effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .
BACKGROUND: Fibromyalgia (FM) is a chronic disorder defined by report of chronic widespread pain including axial pain and presence of multiple tender points on physical exam . Beyond the defining criteria.A recent survey reported balance problems as one of the top 10 most debilitating symptoms with prevalence of 45%. Balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance .
Biodex balance system is a relatively new instrument that can be used for the assessment and management of balance dysfunction. Preliminary studies reported positive effects of balance training on Biodex balance system for the improvement of balance function.
Virtual reality based therapy (VRBT) could be effective as a non-pharmacological alternative intervention to reduce pain in women with FM. It improves dynamic balance, as it is an active therapy that requires engaging in physical activities during the sessions.VRBT requires autonomous movement of different body parts that can increase muscle tone and the perception of pain-free movement favoring the elimination of restrictions to movement included in the cerebral body scheme due to continued pain.
- Conditions
- Virtual Reality
- Being tested
- virtual reality, biodex training, conventional balance exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
virtual reality and biodex training
biodex trainingOther
biodex training
conventional balance exercisesOther
conventional balance exercises
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group ( A) will perform exercise which done by VR and biodex training Receives: Other: virtual reality; Other: biodex training |
| intervention | Experimental | Group (B) will perform biodex training only Receives: Other: virtual reality; Other: biodex training |
| conventional | Other | group (C) will perform conventional balance exercise Receives: Other: conventional balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIODEX BALANCE ASSESMENT
BIODEX used to asses balance
Measured: pre and post treatment 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Apr 2025
- Primary completion29 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Othman, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004101
- Sponsor's protocol ID
- P.T.REC/012/005765
- Status last verified
- Sep 2026
- First submitted
- 18 May 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-based Therapy Combined With Balance Training on Biodex Balance System in Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07004101
- Acronym / sponsor ID
- P.T.REC/012/005765
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 4 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.
Is there an effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .
Detailed description
PURPOSE: To Study the Effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .
BACKGROUND: Fibromyalgia (FM) is a chronic disorder defined by report of chronic widespread pain including axial pain and presence of multiple tender points on physical exam . Beyond the defining criteria.A recent survey reported balance problems as one of the top 10 most debilitating symptoms with prevalence of 45%. Balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance .
Biodex balance system is a relatively new instrument that can be used for the assessment and management of balance dysfunction. Preliminary studies reported positive effects of balance training on Biodex balance system for the improvement of balance function.
Virtual reality based therapy (VRBT) could be effective as a non-pharmacological alternative intervention to reduce pain in women with FM. It improves dynamic balance, as it is an active therapy that requires engaging in physical activities during the sessions.VRBT requires autonomous movement of different body parts that can increase muscle tone and the perception of pain-free movement favoring the elimination of restrictions to movement included in the cerebral body scheme due to continued pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: virtual reality, Other: biodex trainingGroup ( A) will perform exercise which done by VR and biodex training |
| intervention | Experimental | Other: virtual reality, Other: biodex trainingGroup (B) will perform biodex training only |
| conventional | Other | Other: conventional balance exercisesgroup (C) will perform conventional balance exercise |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women patients from age 35 to 50 years old
- All patients describe a history of pain spreading in all quadrants of the body for at least three months and pain is caused by digital pressure in at least 11 out of 18 allogenic points, called tender points
Key exclusion criteria (4 listed)
- Old neglected fracture
- Malignant diseases
- Neurological diseases.
- Uncontrolled diabetes
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 realityvirtual reality and biodex training | Other | Intervention, intervention |
| biodex trainingbiodex training | Other | Intervention, intervention |
| conventional balance exercisesconventional balance exercises | Other | conventional |
Primary outcome
BIODEX BALANCE ASSESMENT
Time frame: pre and post treatment 4 weeks
BIODEX used to asses balance
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 29 Sep 2026.
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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, biodex training and conventional balance exercises in people with Virtual Reality, run by Badr 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 2 inclusion and 4 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 29 Sep 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?
BIODEX BALANCE ASSESMENT (time frame: pre and post treatment 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.