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Osteogenesis ImperfectaNCT06010134

Osteogenesis Imperfecta and Balance

A study testing Physical Therapy Program in people with Osteogenesis Imperfecta, run by South Valley University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteogenesis Imperfecta
What is being tested?
Physical Therapy Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 May 2023to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Their age was ranging from six to twelve years
  • Children participated in this study were from both sexes
  • All children with stable medical and psychological status.
  • They were able to follow the verbal commands or instructions during testing.

Who cannot join

  • Children with visual or auditory problems.
  • Children with any cognitive problems.
  • Children without deformity

Trial locations and contacts

1 site in 1 country.

Nehad Abo-zaid, Assistant Professor contact

+201008980727

dr.nehadahmed@svu.edu.eg

Egypt1 site, 1 recruiting

  • South Valley University, Faculty of Physical Therapy

    Qina, 83523

    Recruiting

Other trials in Egypt

About this study

Official title: Efficacy of Whole Body Vibration on Balance and Motor Control in Children With Osteogenesis Imperfecta

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)

Being tested
Physical Therapy Program
Keywords
Osteogenesis Imperfecta, Whole Body Vibration, Balance, Motor Control
Medical subject headings
Osteogenesis Imperfecta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Therapy ProgramOther

    Physical Therapy Program plus Whole Body Vibration

Study groups in NCT06010134
Study groupRoleWhat they receive
Control GroupExperimentalGroup 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.
Receives: Other: Physical Therapy Program
Study groupExperimentalGroup 2 the study group received the same physical therapy program 15 min. plus Whole Body Vibration for 15 min.
Receives: Other: Physical Therapy Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Over All Stabiity Index

    Stability Index

    Measured: at day 0

  2. Over All Stabiity Index

    Stability Index

    Measured: at day 90

  3. Medio lateral Stabiity Index

    Stability Index

    Measured: at day 0

  4. Medio lateral Stabiity Index

    Stability Index

    Measured: at day 90

  5. Antro posterior Stabiity Index

    Stabiity Index

    Measured: at day 0

  6. Antro posterior Stabiity Index

    Stabiity Index

    Measured: at day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start1 May 2023
  3. Primary completion30 Aug 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06010134
Sponsor's protocol ID
P.T.REC/012/002577
Status last verified
May 2023
First submitted
17 Aug 2023
Last updated
24 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Physical Therapy Program in people with Osteogenesis Imperfecta, run by South Valley University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nehad Abo-zaid, Assistant Professor (+201008980727, dr.nehadahmed@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Over All Stabiity Index (time frame: at day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06010134, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.

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