Osteogenesis Imperfecta and Balance

NCT ID: NCT06010134

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteogenesis Imperfecta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Double (Participant, Investigator) Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (Whole Body Vibration group).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Physical Therapy Program

Intervention Type OTHER

Physical Therapy Program plus Whole Body Vibration

Study group

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

Group Type EXPERIMENTAL

Physical Therapy Program

Intervention Type OTHER

Physical Therapy Program plus Whole Body Vibration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Therapy Program

Physical Therapy Program plus Whole Body Vibration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

South Valley University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nehad Ahmed Youness Abo-zaid

Assistant Professor of Pediatric Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hanady Mohamed

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical Therapy, Benha University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

South Valley University, Faculty of Physical Therapy

Qina, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nehad Abo-zaid, Assistant Professor

Role: CONTACT

+201008980727

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 2805382 (View on PubMed)

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.

Reference Type RESULT
PMID: 27448250 (View on PubMed)

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.

Reference Type RESULT
PMID: 26987995 (View on PubMed)

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.

Reference Type RESULT
PMID: 10831929 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/012/002577

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Electromyostimulation on Bone
NCT01296776 COMPLETED PHASE3
Build Better Bones With Exercise
NCT01761084 COMPLETED NA