NCT07004101

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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 Start

First participant enrolled

April 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 18, 2025

Last Update Submit

May 26, 2025

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • BIODEX BALANCE ASSESMENT

    BIODEX used to asses balance

    pre and post treatment 4 weeks

Study Arms (3)

Intervention

EXPERIMENTAL

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

Other: virtual realityOther: biodex training

intervention

EXPERIMENTAL

Group (B) will perform biodex training only

Other: virtual realityOther: biodex training

conventional

OTHER

group (C) will perform conventional balance exercise

Other: conventional balance exercises

Interventions

virtual realityOTHER

virtual reality and biodex training

Interventionintervention
biodex trainingOTHER

biodex training

Interventionintervention
conventional balance exercisesOTHER

conventional balance exercises

conventional

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Old neglected fracture
  • Malignant diseases
  • Neurological diseases.
  • Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisted professor

Study Record Dates

First Submitted

May 18, 2025

First Posted

June 4, 2025

Study Start

April 15, 2025

Primary Completion

June 20, 2025

Study Completion

June 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations

EG(1)