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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06010134
Other study ID # P.T.REC/012/002577
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date September 30, 2023

Study information

Verified date May 2023
Source South Valley University
Contact Nehad Abo-zaid, Assistant Professor
Phone +201008980727
Email dr.nehadahmed@svu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Osteogenesis Imperfecta (OI), also known as brittle bone disease, is a group of genetic disorders that mainly affect the bones. It results in bones that break easily. Its severity may be mild to severe. Other symptoms may include a blue tinge to the whites of the eye, short height, loose joints, hearing loss, breathing problems and problems with the teeth. Physiotherapy is aimed to strengthen muscles and improve motility in a gentle manner, while minimizing the risk of fracture, and the use of support cushions to improve posture.


Description:

This study aimed to assess the efficacy of Whole Body Vibration on balance and motor function in children with Osteogenesis Imperfecta. Whole body vibration (WBV) therapy is targeted at musculoskeletal strengthening and has been trialed in a variety of conditions. WBV has been shown to have therapeutic advantage in various osteopenic preclinical models and populations such as postmenopausal women (improved mobility, muscle strength, postural strength, and bone density) and children with osteogenesis imperfecta (improved mobility)


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Their age was ranging from six to twelve years 2. Children participated in this study were from both sexes 3. All children with stable medical and psychological status. 4. They were able to follow the verbal commands or instructions during testing. Exclusion Criteria: 1. Children with visual or auditory problems. 2. Children with any cognitive problems. 3. Children without deformity

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical Therapy Program
Physical Therapy Program plus Whole Body Vibration

Locations

Country Name City State
Egypt South Valley University, Faculty of Physical Therapy Qina

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Andersen PE Jr, Hauge M. Osteogenesis imperfecta: a genetic, radiological, and epidemiological study. Clin Genet. 1989 Oct;36(4):250-5. doi: 10.1111/j.1399-0004.1989.tb03198.x. — View Citation

Bishop N. Bone Material Properties in Osteogenesis Imperfecta. J Bone Miner Res. 2016 Apr;31(4):699-708. doi: 10.1002/jbmr.2835. Epub 2016 Mar 26. — View Citation

Folkestad L, Hald JD, Ersboll AK, Gram J, Hermann AP, Langdahl B, Abrahamsen B, Brixen K. Fracture Rates and Fracture Sites in Patients With Osteogenesis Imperfecta: A Nationwide Register-Based Cohort Study. J Bone Miner Res. 2017 Jan;32(1):125-134. doi: — View Citation

Rauch F, Travers R, Parfitt AM, Glorieux FH. Static and dynamic bone histomorphometry in children with osteogenesis imperfecta. Bone. 2000 Jun;26(6):581-9. doi: 10.1016/s8756-3282(00)00269-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Over All Stabiity Index Stability Index at day 0
Primary Over All Stabiity Index Stability Index at day 90
Primary Medio lateral Stabiity Index Stability Index at day 0
Primary Medio lateral Stabiity Index Stability Index at day 90
Primary Antro posterior Stabiity Index Stabiity Index at day 0
Primary Antro posterior Stabiity Index Stabiity Index at day 90
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