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Design and construction of a body balance biofeedback device and investigation of its effect on improving balance, movement, and quality of life in patients with severe bilateral vestibular system dysfunction

Design and construction of a body balance biofeedback device and investigation of its effect on improving balance, movement, and quality of life in patients with severe bilateral vestibular system dysfunction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220119053761N3
Enrollment
40
Registered
2025-09-15
Start date
2025-08-23
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vestibular neuritis. Diseases of the ear and mastoid process

Interventions

In this study, there is an intervention group that is evaluated before and after the interventions. The intervention involves the use of vibrational biofeedback, sound with a Body Balance Biofeedback

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age range 18-60 years Slow phase velocity less than 5 degrees/second in caloric test with two-thermal stimulation Vestibular reflex gain less than 0.2 for all bilateral semicircular canals in the Video Head Impulse test Imbalance with fear of falling or actual falling, despite having previously undergone various types of virtual reality therapy Score less than 20 on the Barg test The patient's satisfaction score with their balance during their daily life is less than 40%. Avoid alcohol and caffeine for 72 hours before the tests. Not taking medications that suppress the vestibular system within 48 hours before the tests.

Exclusion criteria

Exclusion criteria: History of orthopedic problems in the last 6 months based on self-report (lower limb fractures, dislocations, and pain in the lower limbs or trunk) Decreased proprioceptive sensitivity Visual impairment

Design outcomes

Primary

MeasureTime frame
Quality of life questionnaire score Dizziness Handicap Inventory score Sensory organization test stage 5 Posturography Motor control test score in Posturography Berg test score Group (before - after). Timepoint: Before intervention , Two months after intervention. Method of measurement: Quality of Life Questionnaire score (questionnaire) Dizziness Handicap Inventory score (questionnaire) Sensory Organization Test Stage 5 Posturography score (posturography device) Posturography Motor Control Test score (posturography device) Berg Test score (berg test).—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Ashrafi

Shahid Beheshti University of Medical Sciences

m_ashrafi@sbmu.ac.ir+98 21 7756 1721

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026