Osteogenesis Imperfecta and Balance

NCT06010134 | Unknown

• 1 other identifier: P.T.REC/012/002577
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteogenesis Imperfecta

Keywords

Osteogenesis Imperfecta; Whole Body Vibration; Balance; Motor Control

Outcome Measures

Primary Outcomes (6)

• Over All Stabiity Index

  Stability Index

  at day 0

• Over All Stabiity Index

  Stability Index

  at day 90

• Medio lateral Stabiity Index

  Stability Index

  at day 0

• Medio lateral Stabiity Index

  Stability Index

  at day 90

• Antro posterior Stabiity Index

  Stabiity Index

  at day 0

• Antro posterior Stabiity Index

  Stabiity Index

  at day 90

Study Arms (2)

Control Group

EXPERIMENTAL

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

Study group

EXPERIMENTAL

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

Physical Therapy Program OTHER

Physical Therapy Program plus Whole Body Vibration

Control Group; Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 2805382 RESULT

• 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.

  PMID: 27448250 RESULT

• 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.

  PMID: 26987995 RESULT

• 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.

  PMID: 10831929 RESULT

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hanady Mohamed

  Faculty of Physical Therapy, Benha University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nehad Abo-zaid, Assistant Professor

CONTACT

+201008980727; dr.nehadahmed@svu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Physical Therapy

Model Details: 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

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 24, 2023
• Study Start: May 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)