Clinical trial NCT06010134: Osteogenesis Imperfecta and Balance
Official title: Efficacy of Whole Body Vibration on Balance and Motor Control in Children With Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteogenesis Imperfecta
Keywords: Osteogenesis Imperfecta
Whole Body Vibration
Balance
Motor Control
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: G 1 (control) received traditional physical therapy program for 30 min. G 2 (study) received traditional physical therapy program for 15 min. and Whole Body Vibration for 15 min
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Over All Stabiity Index
timeFrame: at day 0
measure: Over All Stabiity Index
timeFrame: at day 90
measure: Medio lateral Stabiity Index
timeFrame: at day 0
measure: Medio lateral Stabiity Index
timeFrame: at day 90
measure: Antro posterior Stabiity Index
timeFrame: at day 0
measure: Antro posterior Stabiity Index
timeFrame: at day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Qina
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
Study officials:
affiliation: Faculty of Physical Therapy, Benha University
name: Hanady Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 10.1002/jbmr.2920. Epub 2016 Aug 29.
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.
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.