Osteogenesis Imperfecta and Balance

August 17, 2023 updated by: Nehad Ahmed Youness Abo-zaid, South Valley University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Qina, Egypt, 83523
        • Recruiting
        • South Valley University, Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Physical Therapy Program plus Whole Body Vibration
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
Physical Therapy Program plus Whole Body Vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Over All Stabiity Index
Time Frame: at day 0
Stability Index
at day 0
Over All Stabiity Index
Time Frame: at day 90
Stability Index
at day 90
Medio lateral Stabiity Index
Time Frame: at day 0
Stability Index
at day 0
Medio lateral Stabiity Index
Time Frame: at day 90
Stability Index
at day 90
Antro posterior Stabiity Index
Time Frame: at day 0
Stabiity Index
at day 0
Antro posterior Stabiity Index
Time Frame: at day 90
Stabiity Index
at day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: Hanady Mohamed, Faculty of Physical Therapy, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/002577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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