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Osteogenesis Imperfecta and Balance

Primary Purpose

Osteogenesis Imperfecta

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Physical Therapy Program
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring Osteogenesis Imperfecta, Whole Body Vibration, Balance, Motor Control

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Children with visual or auditory problems. Children with any cognitive problems. Children without deformity

Sites / Locations

  • South Valley University, Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group

Study group

Arm Description

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

Outcomes

Primary Outcome Measures

Over All Stabiity Index
Stability Index
Over All Stabiity Index
Stability Index
Medio lateral Stabiity Index
Stability Index
Medio lateral Stabiity Index
Stability Index
Antro posterior Stabiity Index
Stabiity Index
Antro posterior Stabiity Index
Stabiity Index

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT06010134
Brief Title
Osteogenesis Imperfecta and Balance
Official Title
Efficacy of Whole Body Vibration on Balance and Motor Control in Children With Osteogenesis Imperfecta
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
Keywords
Osteogenesis Imperfecta, Whole Body Vibration, Balance, Motor Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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).
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Study group
Arm Type
Experimental
Arm Description
Group 2 the study group received the same physical therapy program 15 min. plus Whole Body Vibration for 15 min.
Intervention Type
Other
Intervention Name(s)
Physical Therapy Program
Intervention Description
Physical Therapy Program plus Whole Body Vibration
Primary Outcome Measure Information:
Title
Over All Stabiity Index
Description
Stability Index
Time Frame
at day 0
Title
Over All Stabiity Index
Description
Stability Index
Time Frame
at day 90
Title
Medio lateral Stabiity Index
Description
Stability Index
Time Frame
at day 0
Title
Medio lateral Stabiity Index
Description
Stability Index
Time Frame
at day 90
Title
Antro posterior Stabiity Index
Description
Stabiity Index
Time Frame
at day 0
Title
Antro posterior Stabiity Index
Description
Stabiity Index
Time Frame
at day 90

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Children with visual or auditory problems. Children with any cognitive problems. Children without deformity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nehad Abo-zaid, Assistant Professor
Phone
+201008980727
Email
dr.nehadahmed@svu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanady Mohamed
Organizational Affiliation
Faculty of Physical Therapy, Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qina
ZIP/Postal Code
83523
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2805382
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.
Results Reference
result
PubMed Identifier
27448250
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.
Results Reference
result
PubMed Identifier
26987995
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.
Results Reference
result
PubMed Identifier
10831929
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.
Results Reference
result

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Osteogenesis Imperfecta and Balance

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