ClinicalTrials.gg
RecruitingNCT06010134Updated Aug 24, 2023

Osteogenesis Imperfecta and Balance

An interventional study of Physical Therapy Program in Osteogenesis Imperfecta, sponsored by South Valley University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 2 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled May 2023, registered Aug 2023).
  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Osteogenesis Imperfecta

Keywords

  • Osteogenesis Imperfecta
  • Whole Body Vibration
  • Balance
  • Motor Control
03

In context

Osteogenesis Imperfecta

84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.

This study's planned enrollment of 60 is above the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.

Browse Osteogenesis Imperfecta studies →

Lead sponsor

South Valley University is the lead sponsor of 153 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Children with visual or auditory problems.
  2. Children with any cognitive problems.
  3. Children without deformity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Control Group

    Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand pronator, wrist extensors, knee extensors and ankle dorsiflexors, coordination and balancing exercises.

    Other: Physical Therapy Program

  • Experimental
    Study group

    Group 2 the study group received the same physical therapy program 15 min. plus Whole Body Vibration for 15 min.

    Other: Physical Therapy Program

Interventions

  • OtherPhysical Therapy Program

    Physical Therapy Program plus Whole Body Vibration

06

What researchers measure

Primary outcomes

  1. Over All Stabiity Index

    Stability Index

    Time frame: at day 0

  2. Over All Stabiity Index

    Stability Index

    Time frame: at day 90

  3. Medio lateral Stabiity Index

    Stability Index

    Time frame: at day 0

  4. Medio lateral Stabiity Index

    Stability Index

    Time frame: at day 90

  5. Antro posterior Stabiity Index

    Stabiity Index

    Time frame: at day 0

  6. Antro posterior Stabiity Index

    Stabiity Index

    Time frame: at day 90

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 2805382 ↗
  • 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. PubMed 27448250 ↗
  • 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. PubMed 26987995 ↗
  • 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. PubMed 10831929 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06010134
Responsible party
Nehad Ahmed Youness Abo-zaid (Assistant Professor of Pediatric Physical Therapy, South Valley University) — Principal investigator
First posted
Aug 24, 2023
Start date
May 1, 2023
Primary completion
Aug 30, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Aug 24, 2023

Study contacts

Nehad Abo-zaid, Assistant Professor
Contact
dr.nehadahmed@svu.edu.eg
+201008980727
Hanady Mohamed
principal investigator · Faculty of Physical Therapy, Benha University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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