Effect of Virtual Reality Combined With Balance Training on Biodex Balance System in Female With Fibromyalgia

NCT ID: NCT07004101

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2025-06-30

Brief Summary

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Is there an effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .

Detailed Description

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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

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Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention

Group ( A) will perform exercise which done by VR and biodex training

Group Type EXPERIMENTAL

virtual reality

Intervention Type OTHER

virtual reality and biodex training

biodex training

Intervention Type OTHER

biodex training

intervention

Group (B) will perform biodex training only

Group Type EXPERIMENTAL

virtual reality

Intervention Type OTHER

virtual reality and biodex training

biodex training

Intervention Type OTHER

biodex training

conventional

group (C) will perform conventional balance exercise

Group Type OTHER

conventional balance exercises

Intervention Type OTHER

conventional balance exercises

Interventions

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virtual reality

virtual reality and biodex training

Intervention Type OTHER

biodex training

biodex training

Intervention Type OTHER

conventional balance exercises

conventional balance exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Old neglected fracture
* Malignant diseases
* Neurological diseases.
* Uncontrolled diabetes
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Badr University

OTHER

Sponsor Role lead

Responsible Party

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Dina Othman

Assisted professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/005765

Identifier Type: -

Identifier Source: org_study_id

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